Clinical Trials

NCT04267878: Alchemist: Integration of immunotherapy into adjuvant therapy for resected non-small cell lung cancer.

Study Sponsor: National Cancer Institute

Study Status: Recruiting

The purpose of this study is to test the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery.

Key Inclusion Criteria:

• A female of childbearing potential is a sexually mature female who
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)
• Local testing of ALK with no ALK rearrangement

Hafez Halawani, MD

NCT06692738: Artemide Lung-02: A Phase III, Randomized, Double-blind of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous NSCLC Whose Tumors Express PD-L1 Study

Study Sponsor: AstraZeneca

Study Status: Recruiting

The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Key Inclusion Criteria:

• Histologically or cytologically documented squamous NSCLC.
• Stage IV mNSCLC not amenable to curative treatment.

Key Exclusion Criteria:

• Any severe or uncontrolled systemic diseases, including, but not limited to, uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; ILD, serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease), active non-infectious skin disease requiring systemic treatment, psychiatric illness/social situations, substance abuse, or significant cardiac conditions which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.

Hafez Halawani, MD

NCT06627647: Artemide Lung-03: A Phase III, Randomized, Double-blind, of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 Study

Study Sponsor: AstraZeneca

Study Status: Recruiting

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.

Key Inclusion Criteria:

• Histologically or cytologically documented non-squamous NSCLC. 3 Stage IV mNSCLC not amenable to curative treatment.
• Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.

Key Exclusion Criteria:

As judged by the investigator, any severe or uncontrolled systemic diseases, including, but not limited to, uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; ILD, serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease), active non-infectious skin disease requiring systemic treatment, psychiatric illness/social situations, substance abuse, or significant cardiac conditions which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.

Hafez Halawani, MD

Advanced Precision Observational Lung Living Outcomes (APOLLO): Lung Cancer Screening Study

Study Sponsor: Prognomiq

Study Status: Recruiting

PrognomiQ aims to leverage the latest advances in proteomics to generate direct information of a subject’s biological state, including state of disease.

Key Inclusion Criteria:

• Any gender and ≥ 50 to 80 years of age documented at the time of enrollment
• Current Smoker with ≥ 20 pack-years (pack years = number of packs per day X number of years smoked)
• Reformed Smoker with ≥20 pack-years history with quit date within the past 15 years.

Key Exclusion Criteria:

• Prior history of any cancer 5 years prior to enrollment, except basal cell carcinoma
• Any history of organ transplantation
• Any history of blood product transfusion within 90 days prior to enrollment

Hafez Halawani, MD

Study Sponsor: Shanghai Henlius Biotech

Study Status: Recruiting

Key Inclusion Criteria:

• Male or female > 18 years of age
• Histologically or cytologically diagnosed with ES-SCLC
• No prior systemic therapy for ES-SCLC
• Patients who have received chemoradiotherapy for previous limited stage SCLC must be treated with curative intent and have a treatment-free interval of a least 6 months from the last course of chemotherapy, radiotherapy, or chemoradiotherapy to the diagnosis of extensive stage SCLC
• At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization

Key Exclusion Criteria

• Histologically or cytologically confirmed mixed SCLC.
• Other active malignancies within 5 years or at the same time. Localized tumors that have been cured, such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical cancer in situ and breast cancer in situ are acceptable.
• Patients who are preparing for or have received an organ or bone marrow transplant.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters are allowed regardless of drainage frequency.

Hafez Halawani, MD

URCC21038: Disparities in Results of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti- PD-L1 Immunotherapy in a Community Oncology Setting

Study Sponsor: National Cancer Institute

Study Status: Recruiting

This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

Key Inclusion Criteria:

• Self-identify as African/African American/Black (AA), or European American/Caucasian/white (EA)
• Patients may identify a Hispanic/Latino ethnicity in combination with an AA or EA racial identity
• Have a current diagnosis of invasive cancer at stage I-IV
• Patients may have a history of previous cancer diagnosis and cancer treatment not involving immunotherapy
• Be scheduled to receive anti-PD-1/-L1 ICI-containing therapy alone or in combination with co-treatments (including alternative ICIs)

Key Exclusion Criteria:

• Identify as Asian, Pacific Islander, or American Indian/Alaskan Native
• Be diagnosed with melanoma
• Currently participate in any trials of cancer therapeutic nature
• Have received prior immunotherapy for cancer, including checkpoint inhibitors, CAR-T therapy, cytokine therapy, and/or Bacillus Calmette-Guerin (BCG) for bladder cancer

Hafez Halawani, MD

NCT06018337: DYNASTY-Breast02

Study Sponsor: Dualitybio, Inc.

Study Status: Recruiting

The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323, an anti-HER2 ADC, compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry [IHC]2+/in situ hybridization [ISH]- and IHC 1+) population.

Key Inclusion Criteria:

• Advanced metastatic breast cancer
• HER2-low expression (IHC 1+ or IHC 2+/ISH-) as determined by the central laboratory result.
• Was never previously reported as HER2-positive (IHC 3+ or ISH+)
• Is documented as HR+ (either estrogen receptor [ER] and/or progesterone receptor [PgR] positive [ER or PgR ≥1%]).
• Disease progression on endocrine therapy for metastatic disease.
• No prior chemotherapy for advanced or metastatic breast cancer.

Key Exclusion Criteria:

• Uncontrolled intercurrent illness, including ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement or compromise the ability of the subject to give written informed consent.
• Previous treatment with anti-HER2 therapy.

Andrea Teague, MD

NCT06657144 A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors

Study Sponsor: Coherus Oncology, Inc.

Study Status: Recruiting

The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.

Key Inclusion Criteria:

• At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.
• Cohort A: Histologically or cytologically documented unresectable, locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma that is human epidermal growth factor receptor 2 (HER2) - negative and microsatellite stable (MSS)/proficient mismatch repair (pMMR).
• Progressed during or after first line systemic therapy that includes a platinum and fluoropyrimidine doublet with or without anti-programmed death receptor 1 (PD-1)/programmed death ligand 1 (PD-L1)-directed therapy (that is, in the second line setting). OR
• Cohort B: Histologically or cytologically documented unresectable, locally advanced or metastatic Esophogeal Squamous Cell Carcinoma (ESCC).
• Progressed during or after first line systemic therapy including a doublet of platinum and fluoropyrimidine or paclitaxel with or without anti-PD-1/PD-L1-directed therapy or anti-CTLA-4 and anti-PD-1/PD-L1-directed combination therapy. OR
• Cohort C: Histologically or cytologically documented unresectable, locally advanced or metastatic Esophogeal Squamous Cell Carcinoma (ESCC). (1L treatment)

Key Exclusion Criteria:

• Symptomatic or untreated central nervous system metastases
• Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.

Andrea Teague, MD

NCT06764875 A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

Study Sponsor: AstraZeneca

Study Status: Recruiting

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

Key Inclusion Criteria:

• HER2 positive for gastric cancer on a tumor biopsy.
• PD-L1 combined positive score (CPS) ≥ 1.
• Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.

Key Exclusion Criteria:

• Spinal cord compression or brain metastases unless asymptomatic, treated and stable
• History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).

Andrea Teague, MD

NCT05434234: YL201-INT-101-01

Study Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Study Status: Recruiting

This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2).

Part 1 will estimate the maximum tolerated dose in cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available.

Part 2 will include patients with selected advanced solid tumor types, to better define the safety profile and evaluate the efficacy of YL201.

Key Inclusion Criteria:

• Good functional status
• Adequate organ and bone marrow function
• Life expectancy of ≥3 months
• Pathologically confirmed diagnosis of an advanced solid tumor for which prior standard treatment had proven to be ineffective or intolerable, or no standard treatment is available

Key Exclusion Criteria:

• Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and Dxd.
• Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 2 weeks before the first dose of study drug.

Andrea Teague, MD

NCT06629779: MEVPRO-2 (C2321003)

Study Sponsor: Pfizer Inc.

Study Status: Recruiting

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

Key Inclusion Criteria

• Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
• Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
• Progressive disease in the setting of medical or surgical castration.

Key Exclusion Criteria

• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that make the participant inappropriate for the study.
• Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment.

Andrea Teague, MD

NCT05434234: YL201-INT-101-01

Study Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Study Status: Recruiting

This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2).

Part 1 will estimate the maximum tolerated dose in cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available.

Part 2 will include patients with selected advanced solid tumor types, to better define the safety profile and evaluate the efficacy of YL201.

Key Inclusion Criteria:

• Good functional status
• Adequate organ and bone marrow function
• Life expectancy of ≥3 months
• Pathologically confirmed diagnosis of an advanced solid tumor for which prior standard treatment had proven to be ineffective or intolerable, or no standard treatment is available

Key Exclusion Criteria:

• Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and Dxd.
• Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 2 weeks before the first dose of study drug.

Andrea Teague, MD

NCT05434234: YL201-INT-101-01

Study Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Study Status: Recruiting

This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2).

Part 1 will estimate the maximum tolerated dose in cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available.

Part 2 will include patients with selected advanced solid tumor types, to better define the safety profile and evaluate the efficacy of YL201.

Key Inclusion Criteria:

• Good functional status
• Adequate organ and bone marrow function
• Life expectancy of ≥3 months
• Pathologically confirmed diagnosis of an advanced solid tumor for which prior standard treatment had proven to be ineffective or intolerable, or no standard treatment is available

Key Exclusion Criteria:

• Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and Dxd.
• Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 2 weeks before the first dose of study drug.

Andrea Teague, MD

NCT06679985: CHS-388-202

Study Sponsor: Coherus BioSciences, Inc.

Study Status: Recruiting

The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.

Key Inclusion Criteria:

• Unresectable locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic participants.
• Disease that is not amenable to curative surgical and/or locoregional therapies or progressive disease (PD) after surgical and/or locoregional therapies.

Key Exclusion Criteria:

• Has received prior systemic therapy for HCC.
• Has previously received an anti-IL-27 antibody (Ab) or anti-IL-27-targeted therapy.
• Has known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• Has moderate or severe ascites.

Andrea Teague, MD

NCT06624085: GO44900

Study Sponsor: F. Hoffmann-La Roche Ltd.

Study Status: Recruiting

The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Key Inclusion Criteria:

• Histologically confirmed DLBCL, not otherwise specified (NOS)
• Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed < 6 months after completion of the last line of therapy) disease
• At least one prior line of systemic therapy
• Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)

Key Exclusion Criteria:

• Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
• Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease

Andrea Teague, MD

NCT05552222: MajesTEC-7

Study Sponsor: Janssen Research & Development, LLC

Study Status: Recruiting

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

Key Inclusion Criteria:

• Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
• Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment

Key Exclusion Criteria:

• Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams [mg] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 mg of dexamethasone within 14 days before randomization

Andrea Teague, MD

NCT06657144: A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors

Study Sponsor: Coherus Oncology, Inc.

Study Status: Recruiting

The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.

Key Inclusion Criteria:

• Histologically and/or cytologically documented unresectable advanced or metastatic colorectal adenocarcinoma.
• Participants who have no approved standard therapies with a proven clinical benefit available in the participant's country.
• Participants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxalipatin-based therapy in the metastatic setting.

Key Exclusion Criteria:

• Symptomatic or untreated central nervous system metastases
• Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.
• Active uncontrolled bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.

Andrea Teague, MD

NCT06455475: Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

Study Sponsor: Royal Wound-X

Study Status: Recruiting

This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers.

Key Inclusion Criteria:

• Subjects 18 years of age or older. At least 50% of the enrolled population must be > 65 years of age.
• Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and/or insulin replacement therapy.
• A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.

Key Exclusion Criteria:

• Subject has ulcers that are completely necrotic or fibrotic tissue
• Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
• Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).

Anna Young, MD

LCHBOT2025

Study Sponsor: Investigator-Initiated Study

Study Status: Recruiting

This is a survey-based study designed to gather information about Long Covid symptoms and treatment outcomes in patients who have undergone Hyperbaric Oxygen Therapy (HBOT). These surveys will assess the effects of HBOT on various health outcomes, but participants will not be receiving the HBOT treatment itself as part of this study. The focus is solely on evaluating these outcomes through survey responses.

Anna Young, MD

C2H - Create to Heal: A Study on the Impact of the Pilot Create to Heal Program on Patients’ Quality of Life and Ability to Communicate, Create, and Manage Stress at Different Stages of Cancer Care.

Study Status: Not Recruiting, last cohort in session - Permanent offering coming soon

This study uses patient-facing questionnaires and demographic data to investigate the impact of Create to Heal- an interactive course designed to incorporate meditation, gratefulness, and creativity into patient care and provide patients with skills to enhance their communication and emotional management.

The goal of this study is to evaluate the impact of the Create to Heal Program on various facets of cancer patients’ experience, including physical pain, stress, communication, and creativity. The study also assesses which patients are most likely to participate in and benefit from similar activities, and intends to quantitatively investigate the benefits of the pilot Create to Heal program so that it may be a permanent option for patients receiving care at the CSV Cancer Center.

Caitlyn Pallas, MS and Patricia Varga, BA

NCT03053193: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles (FLEX)

Study Sponsor: Flex/Agendia

Study Status: Recruiting

Key Inclusion Criteria:

• Receiving or received adjuvant therapy after definitive surgery
• Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing as standard of care (male or female)
• Informed consent form signed on the same day or before enrollment
• New primary lesion
• 18 years of age or older

Key Exclusion Criteria:

• Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria, or insufficient material to obtain full genome data
• Metastatic disease
• Recurrent disease
• Stage 0 disease

Swetha Panati, MD

NCT059296798: A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)

Study Sponsor: Herdera

Study Status: Active, closed for enrollment at our site

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination with Phesgo Versus Phesgo after Induction Therapy with Phesgo + Taxane in Patients with Previously Untreated HER2 –Positive, Estrogen Receptor-Positive , Estrogen Receptor –Postively Locally-Advanced or Metastatic Breast Cancer

Key Inclusion Criteria:

• HER2+/ER+ histologically or cytologically confirmed mBC or LABC not amenable to curative resection.
• At least one measurable lesion and/or non-measurable disease evaluable according to RECIST version 1.1
• Disease-Free interval from completion of adjuvant or neoadjuvant systemic nonhormonal treatment to recurrence of >6 months
• ECOG 0 –1

Key Exclusion Criteria:

• Previous systemic non-hormonal anti-cancer therapy in the MBC or ABC setting
• Prior treatment with a SERD (e.g., fulvestrant)
• Known active uncontrolled or symptomatic central nervous system (CNS).

Swetha Panati, MD

NCT03053193: BF1 NSCL & Non-Cancer

Study Sponsor: Aurora Research Institute

Study Status: Recruiting

Procurement of Human Biospecimens for the Discovery and Validation of Biomarkers for the Prediction, Diagnosis and Management of Disease.

Key Inclusion Criteria - Lung Cancer:

• Age 50 to 80 years old
• Current or Former Smoker
  • Former smokers within the past 15 years
• ≥ 20 pack-years
• Suspicion of Lung Cancer based on CT or confirmation by any method

Key Inclusion Criteria - Non-Cancer:

• Age 50 to 80 years old
• Current or Former Smoker
• ≥ 20 pack-years
• No clinical and/or radiological findings that indicate suspicion of lung cancer (i.e. no lung nodules, <6mm lung="" nodules,="" or="">6mm lung nodules with no change from prior CT scan)

Key Exclusion Criteria - Both Cohorts:

• Any history of previous cancer or therapy for cancer
• Any history of hematologic malignancies or myelodysplasia
• Any history of organ tissue transplantation
• Any history of blood product transfusion
• Current pregnancy

Swetha Panati, MD

NCT06295731: INBRX Head & Neckr

Study Sponsor: Inhibrix Biosciences, Inc.

Study Status: Active, Recruiting

HexAgon-HN: Phase 2/3 study of hexavalent OX40 agonist INBRXX-106 add on to pembrolizumab in 1L R/M HNSCC with PD-L1 CPS >20

Key Inclusion Criteria:

• R/M HNSCC considered incurable by local therapies
• Primary location: oral cavity, oropharynx, hypopharynx, or larynx
• Measurable disease by RECIST 1.1
• PD-L1 CPS >20 by central PD-L1 IHC 22C3 pharmDx
• For Oropharyngeal cancer only: HPV status by central p16 IHC
• Prior curative-intent treatment or locoregionally advanced HNSCC allowed if progressive disease occurred >6 months after completion of treatment.

Key Inclusion Criteria - Non-Cancer:

• Age 50 to 80 years old
• Current or Former Smoker
• ≥ 20 pack-years
• No clinical and/or radiological findings that indicate suspicion of lung cancer (i.e. no lung nodules, <6mm lung="" nodules,="" or="">6mm lung nodules with no change from prior CT scan)

Key Exclusion Criteria

• Rapidly progressing disease, high risk of tumor-associated bleeding, or uncontrolled tumor pain
• Current or history of active autoimmune disease
• Prior systemic treatment for R/M HNSCC

Swetha Panati, MD

NCT04910269: OTAC

Study Status: Active, Recruiting

An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19

Key Inclusion Criteria:

• Clinical risk based on age >55 yrs or an adult (age ≥18 years) with an immunosuppressed condition.
• Positive Test for SARS-CoV-2 within ≤5
• Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV02 infection.

Key Exclusion Criteria

• Asymptomatic and had prior symptoms from the current infection that have now resolved (for >24hrs).

Srikanth Ramachandruni, MD

NCT04910269: BASIC PRoject

Study Sponsor: University of Michigan

Study Status: Active, Recruiting

Brain Attack Surveillance in Corpus Christi

Key Inclusion Criteria:

• Nueces County resident at least 6 months a year
• English or Spanish speaking
• Community dwelling or nursing home

Key Exclusion Criteria

• None

Study Population: Residents of Nueces County, Texas

Morgan Campbell, MD

Lewis Morgenstern, MD

NCT05267821: Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)

Study Sponsor: PRECISE

Study Status: Recruiting

The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyper-inflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).

NCT03896763: PROSpect: Prone and Oscillation Pediatric Clinical Trial

Study Sponsor: PROSPECT

Study Status: Recruiting

Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is to identify the best positional and/or ventilation practice that leads to improved patient outcomes in these critically ill children.

NCT06420297: OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Study Sponsor: ACADIA Pharmaceuticals Inc.

Study Status: Enrolling by Invitation

This is a long-term, OLE study to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS. Subjects who complete the antecedent double-blind study (ACP-101-302) will be invited to participate in the present study.

Elizabeth Roeder, MD

NCT06144645: A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS (VNS4PWS)

Study Sponsor: Foundation for Prader-Willi Research

Study Status: Recruiting

The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.

Elizabeth Roeder, MD

Study Status: Recruiting

The primary objective of the study is to improve the quality of clinical research and medical care for people with Prader-Willi syndrome (PWS) across the lifespan through collaborative investigation and research to support evidence-based care. This objective will be accomplished by establishing a central repository for the consistent collection of data from participants who receive medical care at PWS-Clinical Investigation Collaborative (PWS-CLIC) member sites. This study will expand the shared evidence base and support learning from every patient.

Key Inclusion Criteria:

• Male and Female individuals with Prader-Willi Syndrome

Elizabeth Roeder, MD

Cancer Genetics

Study Sponsor: ACCESS/REDIAL

Study Status: Recruiting

Multi-site study data and blood registry seeking to understand risk factors for the development of childhood cancers, tumors, benign tumors, histiocytic disease, and blood disorders. This study is funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

Key Inclusion Criteria:

• Diagnosis of a childhood cancer, benign tumor, histiocytic disease, or hematological condition
• Age 21 years or younger at diagnosis

Inclusion Criteria for Control Group:

• Any infant/child/adolescent 21 years of age or younger who is not diagnosed or treated for cancer or a hematological condition.
• OR Any healthy siblings of children and adolescents diagnosed with cancer or hematological condition 21 years of age or younger.

Dimarys Sanchez, MD

NCT05255601: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma (RELATIVITY-069)

Study Sponsor: Bristol-Myers Squibb

Study Status: Recruiting

The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.

Latha Prasannan, MD

Childhood Cancer Studies

Study Sponsor: Children's Oncology Group

Study Status: Recruiting

Research studies for the treatment of:

• Hematologic malignancies
• Solid tumors
• Central Nervous System (Brain) Tumors
• Rare cancers

Julie Voeller, MD

NCT04621279: Cool Prime Comparative Effectiveness Study for Mild HIE (COOLPRIME)

Study Sponsor: University of Texas Southwestern Medical Center

Study Status: Recruiting

To determine the effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family. Determine heterogeneity of the treatment effect across key subgroups obtained in the first 6 hours after birth prior to the decision to initiate therapy.

Kaashif Ahmad, MD

NCT02774746: Gastroschisis Outcomes of Delivery (GOOD) Study

Study Sponsor: Medical College of Wisconsin

Study Status: Recruiting

The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks.

Reinaldo Acosta, MD

NCT06082453: Modernizing Perinatal Syphilis Testing

Study Sponsor: The University of Texas Health Science Center, Houston

Study Status: Recruiting

The primary objective of the study is to evaluate the testing performance of two diagnostic molecular techniques [quantitative polymerase chain reaction (qPCR) and transcription-mediated amplification (TMA)] for the detection of Treponema pallidum in maternal and neonatal specimens from participants with the diagnosis of syphilis using the Centers for Disease Control's (CDC's) Sexually Transmitted Infections (STI) Treatment Guidelines for adult and congenital syphilis.

James Hill, MD

NCT04174157: Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)

Study Sponsor: Novartis Pharmaceuticals

Study Status: Recruiting

The purpose of this registry is to assess the long-term outcomes of patients with SMA in the context of advances in treatment options and also to characterize and assess long-term safety and effectiveness of OAV-101.

Melissa Svoboda, MD

NCT05232929: Long-term Follow-up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA) (WeSMA)

Study Sponsor: Genentech, Inc.

Study Status: Active, Not Recruiting

A multi-center, longitudinal, prospective, non-comparative study to investigate the long-term safety and effectiveness of risdiplam, prescribed based on clinician judgment as per the Evrysdi® U.S. Package Insert (USPI) in adult and pediatric participants with SMA. In this study, participants will be followed for the duration of the study or until withdrawal of consent, loss to follow-up, or death. Participants who discontinue risdiplam may still remain in the study, if they agree to continue participating in the follow-up assessments.

Melissa Svoboda, MD

NCT03672422: Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

Study Sponsor: Aliye Uc

Study Status: Completed

The investigators will enroll a total of 628 patients under 18 years of age with ARP or CP. Included in the total are the 357patients in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years. Patient questionnaires and physician surveys will be applied at the time of enrollment and annually thereafter as long as possible. At the first study visit after turning 18 years of age, the patient will sign the informed consent to continue in the study. Specifically, the investigators will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae.

R. Adam Noel, MD

A012103: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

Study Sponsor: Alliance

Study Status: Recruiting

This study compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

Key Inclusion Criteria:

Triple Negative Breast Cancer

• Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of diagnosis, as determined by the investigator in radiologic assessment, clinical assessment or both.
• Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual DCIS is allowed. Isolated tumor cells are considered node-negative.

Prior Treatment

• Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles.
• An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.

Key Exclusion Criteria:

• No stage IV (metastatic) breast cancer
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Neelima Chintapalli, MD

NRG-BR009: Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER+/HER2- Breast Cancer and Oncotype ≤ 25

Study Sponsor: NRG Oncology

Study Status: Recruiting

This Phase III study will determine whether adjuvant chemotherapy added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Key Inclusion Criteria:

• Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry.
• Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.

Oncotype DX RS requirements*:

• If node-negative:
  • Oncotype DX RS must be RS 21-25, or
  • Oncotype DX RS must be 16-20 and disease must be high clinical risk
• If 1-3 nodes involved:
  • Oncotype DX RS must be < 26.
    • The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks.

Key Exclusion Criteria:

• Evidence of metastatic disease.
• pT4 tumors, including inflammatory breast cancer.

Neelima Chintapalli, MD

MK-6482-029: A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)

Study Sponsor: Merck

Study Status: Recruiting

The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) unresectable metastatic breast cancer.

Key Inclusion Criteria:

• Has a diagnosis of ER+/HER2- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent.
• Has documented radiographic confirmation of disease progression during or after the last administered ET prior to entering the study.
• Has received ET in the noncurative setting AND has:
  • Radiographic disease progression on 12 months or more of ET in combination with CDK4/6 inhibitor in the noncurative setting. OR
  • Received at least 2 lines of ET in the noncurative setting including CDK4/6 inhibitor where the CDK 4/6 inhibitor was discontinued due to intolerance (not due to progression).

Note: Prematurely discontinued CDK4/6 inhibitor in combination with ET does not need to be the most recent therapy in the noncurative setting. Refer to Section 8.1.4.2 for definitions of prior lines of therapy.

Key Exclusion Criteria:

• Breast cancer amenable to treatment with curative intent.
• Tumor known to harbor ESR1 mutation.
• Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting.

Christopher Snead, MD

BGB-3111-308: A Phase 3 Randomized, Open-Label, Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Study Sponsor: BeiGene

Study Status: Recruiting

The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab in participants with relapsed/refractory (R/R) follicular lymphoma.

Key Inclusion Criteria:

• Histologically confirmed Grade 1-3a Follicular Lymphoma
• Previously treated with at least one line of systemic therapy including anti-CD20 monoclonal antibody (≥ 4 doses as consecutive monotherapy or ≥ 2 doses as consecutive combination therapy).
• Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy.

Key Exclusion Criteria:

Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma or Grade3b FL. If transformation is suspected, a biopsy of the suspected area is required to exclude transformation.

Deepika Ralla, MD

PROCLAIM 20170770: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

Study Sponsor: Amgen

Study Status: Recruiting

This Phase 3 study is for the treatment of chemotherapy induced thrombocytopenia (CIT) in adult subjects receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer.

Key Inclusion Criteria:

• Stage I, II, III or IV locally advanced or metastatic of the following tumor types: NSCLC, breast cancer, or ovarian cancer (includes fallopian tube epithelial carcinomas and peritoneal epithelial carcinoma of unknown primary), or any stage recurrent disease.
• Must be receiving cancer treatment with 21- or 28-day cycles, using a carboplatinum-based combination chemotherapy regimens.
• Must have a local platelet count ≤ 85 x 109 /L on study day 1.
• Must have at least 3 remaining planned cycles of chemotherapy at study enrollment.

Key Exclusion Criteria:

• New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. To be eligible, must have received at least 14 days of anticoagulation for a new thrombotic event and considered to be stable and suitable for continued therapeutic anticoagulation during trial participation.

Christopher Snead, MD

WF-1901: Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

Study Sponsor: Wake Forest

Study Status: Recruiting

To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in pain severity and pain interference from baseline to the post-intervention assessment for cancer survivors with persistent pain.

Key Inclusion Criteria:

• Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy. Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
• May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.
• Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment.
• Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment.

Key Exclusion Criteria:

• Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).

Neelima Chintapalli, MD

ORACLE: Observation of ResiduAl Cancer with Liquid biopsy Evaluation

Study Sponsor: Guardant Health

Study Status: Recruiting

The purpose of this study is to demonstrate the ability of a novel ctDNA assay to detect recurrence in individuals treated for early-stage solid tumors.

Key Inclusion Criteria:

Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:

Primary Study Cohorts:

• Cohort 1: Muscle invasive (stage II-III) urothelial carcinoma of the bladder or upper urinary tract (i.e.urethra,ureter, or renal pelvis
• Cohort 2: Non-small cell lung cancer (stage IB-III)
  • Cohort 2A: Resectable
  • Cohort 2B: Unresectable
• Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following:
  • Cohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR
  • Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR
  • Cohort 3C: High-risk3 HR-positive/HER2-negative invasive breast carcinoma
• Cohort 4: Stage IIB-III cutaneous melanoma or limited stage IV (meaning metastatic sites are considered treatable with curative intent) melanoma
• Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)
• Cohort 6: Gastric adenocarcinoma (stage II-III)
• Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection
• Cohort 8: Invasive squamous cell carcinoma of the head and neck4
• Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma5
• Cohort 10: Endometrial carcinoma (FIGO stage II-III)
• Cohort 11: High-risk renal cell carcinoma7

Exploratory Cohort:

• Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge)

Steven Scott Boniol, MD

Artemide Lung-02: A Phase III, Randomized, Double-blind of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous NSCLC Whose Tumors Express PD-L1 Study

Study Sponsor: AstraZenca

Study Status: Recruiting

The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Key Inclusion Criteria:

• Histologically or cytologically documented squamous NSCLC.
• Stage IV mNSCLC not amenable to curative treatment.

• Any severe or uncontrolled systemic diseases, including, but not limited to, uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; ILD, serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease), active non-infectious skin disease requiring systemic treatment, psychiatric illness/social situations, substance abuse, or significant cardiac conditions which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.

Neelima Chintapalli, MD

Artemide Lung-03: A Phase III, Randomized, Double-blind, of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 Study

Study Sponsor: AstraZeneca

Study Status: Recruiting

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.

Key Inclusion Criteria:

• Histologically or cytologically documented non-squamous NSCLC. 3 Stage IV mNSCLC not amenable to curative treatment.
• Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.

Key Exclusion Criteria:

• As judged by the investigator, any severe or uncontrolled systemic diseases, including, but not limited to, uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; ILD, serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease), active non-infectious skin disease requiring systemic treatment, psychiatric illness/social situations, substance abuse, or significant cardiac conditions which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.

Neelima Chintapalli, MD

NCT05296798: PROACT Lung

Study Sponsor: Hoffmann-La Roche

Study Status: Recruiting

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer

This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.

Sunil Patel, MD

CARIS Solid Tumor

Study Sponsor: Caris Life Sciences

Study Status: Recruiting

Solid Tumor Matched Tissue & Blood Collection

Key Inclusion Criteria:

• Patients with confirmed Stage Ill or IV disease of any solid tumor type
• Patients scheduled for or recently undergone a biopsy or surgical resection as part of their routine care who agree to have their blood drawn for research purposes
• Patients who are scheduled to submit or have submitted recently procured tissue for Caris Molecular Intelligence testing as a part of their routine care
• Patients able to provide blood sample in close proximity to biopsy or surgical procedure

Key Exclusion Criteria:

• Patients diagnosed with a second primary cancer with the exception of non-melanoma skin cancer
• Patients actively receiving systemic therapy for treatment of cancer
• Patients pregnant at the time of blood draw and/or tissue procurement
• Specimens sent for CMI that include Fine Needle Aspirate (FNA), Cytology, Bone Marrow, or Bone

Sunil Patel, MD

CARIS Fusion

Study Sponsor: Caris Life Sciences

Study Status: Recruiting

Fusion Blood Collection

Key Inclusion Criteria:

• Patients with confirmed Driver Fusions (RET, ROS1, ALK, NTRK, FGFR)
• Patients must have active disease at the time of enrollment
• Patients who are scheduled to submit or have submitted recently procured tissue for Caris Molecular Intelligence testing as a part of their routine care

Key Exclusion Criteria:

• Patients in remission/complete response
• Patients diagnosed with a second primary cancer with the exception of non-melanoma skin cancer

Sunil Patel, MD

PRECISION ONC-22

Study Sponsor: PRECISION for Medicine

Study Status: Recruiting

NSCLC Serum and Streck Plasma

Key Inclusion Criteria:

• Subject must have a histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).
  • Subject can have a documented diagnosis of a secondary cancer.
• Subject must be treatment naïve; no history of curative surgery, radiation therapy, and/or therapeutic regimen for NSCLC.

Key Exclusion Criteria:

• Subject with a NSCLC subtype of not otherwise specified (NOS).
• Subject previously treated with excisional surgery, radiation, or therapeutics.

Sunil Patel, MD

PRECISION ONC-37

Study Sponsor: PRECISION for Medicine

Study Status: Recruiting

Diffuse Large B-Cell Lymphoma

Key Inclusion Criteria:

• Subject must have a histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).
• The subject must be at least 45 years of age and deemed competent to give informed consent by the physician, study nurse or other health care professional interviewing the subject.

Key Exclusion Criteria:

• Subject with any condition, in the opinion of the investigator, that would interfere with the ability to complete the study or for which collection of the biospecimens would result in significant risk to the subject.
• Pregnant or lactating subjects.
• Subject with prior CAR-T therapy treatment history.
• Subject with recent infusion therapy within the past 14 days of collection.
• Subject with recent radiation treatment within the past 30 days of collection.

Sunil Patel, MD

PRECISION ONC-34

Study Sponsor: PRECISION for Medicine

Study Status: Recruiting

Suspicious Lung Nodules – Blood Collection

Key Inclusion Criteria:

• Subjects must have at least ONE suspicious nodule with a diameter between 5 – 30mm identified by radiology that has not been biopsied or undergone surgery.

Key Exclusion Criteria:

• Subject must not have any condition that in the opinion of the investigator, would interfere with the ability of the potential subject to complete the study or for which collection of the biospecimens would result in significant risk to the subject.
• Subjects that have any surgical prep, including fasting or anesthesia. Biospecimens cannot be taken from an IV or should not be collected on the day of surgery.
• Subjects that have had any portion of the lung removed (this includes needle biopsies and bronchoscopy).

Sunil Patel, MD

PRECISION ONC-52

Study Sponsor: PRECISION for Medicine

Study Status: Recruiting

Colorectal Cancer Collection

Key Inclusion Criteria:

• Subject must self-report negative for HIV, or Hepatitis A, B, or C.

Key Exclusion Criteria:

• Subject with any condition, in the opinion of the investigator, that would interfere with the ability to complete the study or for which collection of the biospecimens would result in significant risk to the subject.

Sunil Patel, MD

AUD Sow-15

Study Sponsor: Audubon Bioscience

Study Status: Recruiting

Biomarker Discovery

Key Inclusion Criteria:

• Has at least one indeterminant nodule with a diameter between 5 and 30mm identified by radiology that has not been biopsied or received surgery.
• One of the following criteria is met:
  • Solitary Pulmonary Nodule (SPN; Mayo Clinic Model) probability of malignancy above 1% for at least one nodule.
  • Meets USPSTF guidelines for screening:
    • ≥50 years old
    • ≥20 pack-years smoking history
• The patient and the treating physician intend to conduct a biopsy procedure performed by the treating physician as the next step in the differential diagnosis of the patient’s indeterminate lung nodule.

Key Exclusion Criteria:

• The patient has received surgical prep, including antibiotics, anesthesia, etc. Fasting is not exclusionary.
• Previous cancer diagnosis of any origin (basal cell carcinoma of the skin and squamous cell carcinoma of the skin is not exclusionary so long as the only treatment received was surgery and the treating physician does not suspect the lung nodule is a metastasis of the previous cancer).

Sunil Patel, MD

PRECISION ONC-47

Study Sponsor: PRECISION for Medicine

Study Status: Recruiting

Sunil Patel, MD

APOLLO

Study Sponsor: prognomiQ

Study Status: Recruiting

Advanced Precision Observational Lung Living Outcomes (APOLLO): Lung Cancer Screening Study

The objective of this study is to develop new and/or validate a panel of blood-based biomarkers and candidate classifiers developed by PrognomiQ for lung cancer detection in patients undergoing lung cancer screening.

Reginald Baptiste, MD

NCT05478304: LeAAPS

Study Sponsor: AtriCure, Inc.

Study Status: Active, Not Enrolling

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Key Inclusion Criteria:

• Subjects ≥ 18 years of age
• Documentation of any of the following clinical criteria:
  • CHA2DS2-VASc ≥ 4 with age ≥ 65
  • CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
  • CHA2DS2-VASc = 3 with age ≥ 75
  • CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
  • CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP

Key Exclusion Criteria:

• Clinically significant atrial fibrillation or atrial flutter:
  • Anytime in the past and
  • Documented by an electrocardiographic recording and
  • Episode lasting 6 minutes or longer
• Prior procedure involving opening the pericardium or entering the pericardial space
• Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
• Planned cardiac surgical procedure using non-sternotomy approaches
  • Partial sternotomies will be allowed.
• Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
• Active endocarditis

James Caccitolo, MD

NCT06122077: PROACT Lung

Study Sponsor: Freenome Holdings, Inc.

Study Status: Recruiting

The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine, standard-of-care screening Low-Dose Computed Tomography (LDCT).

Key Inclusion Criteria:

• Age 50 years or older within 30 days of enrollment
• Current or former smoker with a cumulative smoking history of ≥ 20 pack-year
• Able to comprehend and willing to sign and date the informed consent and HIPAA authorization documents 

Key Exclusion Criteria:

• Any active therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy at the time of enrollment
• History of any malignancy within prior 5 years of enrollment (except for non-melanoma skin cancer)
• History of organ, tissue, and bone marrow transplantation
• Screened for lung cancer or having chest CT scan 12 months before enrollment

Suman Sinha, MD

Advanced Precision Observational Lung Living Outcomes (APOLLO): Lung Cancer Screen Study

Study Sponsor: PrognomiQ

Study Status: Recruiting

The objective of this study is to develop new and/or validate a panel of blood-based biomarkers and candidate classifiers developed by PrognomiQ for lung cancer detection in patients undergoing lung cancer screening.

Key Inclusion Criteria:

• Subject is 50 - 80 years of age documented at time of enrollment
• The subject is a current smoker with ≥ 20-pack years (pack years = number of packs per day x number of years smoked) OR the subject is a reformed smoker with ≥ pack-year history with quit date within past 15 years.
• The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
• The subject is willing to comply with study-related procedures.
• The subject is willing and able to donate up to 50 mL of blood via venipuncture.

Key Exclusion Criteria:

• The subject has a prior history of any cancer 5 years prior to enrollment, except basal cell carcinoma.
• The subject has any history of organ transplantation.
• The subject has any history of blood transfusion within 90 days, prior to enrollment.
• The subject is unable to comply with study-related procedures.

Suman Sinha, MD

Venclose

Study Sponsor: Becton Dickinson and Company (BD)

Study Status: Follow-up

A Post-Market, Multi-Center, Prospective, Interventional Study using the Venclose™ System and Venclose MAVEN™ System for Treatment of Chronic Venous Insufficiency of the Great and Small Saphenous Veins and Incompetent Perforator Veins Study Type: Post-Market Interventional.

The purpose of this clinical investigation is to provide clinical evidence to demonstrate reasonable assurance of safety and effectiveness of the Venclose devices for Great Saphenous Vein and Small Saphenous Vein (GSV/SSV) and Incompetent Perforator Vein (IPV) treatment of Chronic Venous Disease (CVD).

Jeffrey Carr, MD

NCT02910414: TARGET BPI

Study Sponsor: Ablative Solutions, Inc.

Study Status: Follow-up

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension

Jeffrey Carr, MD

NCT05055297: SELUTION BTK

Study Sponsor: MedAlliance, LLC

Study Status: Start up

SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.

Key Inclusion Criteria:

• Subject age is ≥ 18 years or older depending on local regulations
• Subject life expectancy is ≥ 1 year
• Subject has documented chronic limb-threatening ischemia in the target limb with Rutherford classification category 4 or 5 and symptoms of ≥ 2 weeks duration

Key Exclusion Criteria:

• Subject has extensive tissue loss (Rutherford category 6) extending above the trans metatarsal level, salvageable only with complex food reconstruction or non-traditional trans metatarsal amputations. This includes subjects with:
  • Osteomyelitis involving proximal to the metatarsal head(s)
  • Any heel wound or wound with calcaneal bone involvement

NCT05868148: shoulder iD

Study Sponsor: Stryker Trauma and Extremities

Study Status: Enrolling

Shoulder ID™ Primary Reversed Glenoid Outcomes Clinical Study (SiD)

The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.

Key Inclusion Criteria

• 18 years or older at the time of the informed consent or non-opposition (when applicable).
• Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
• Willing and able to comply with the requirements of the study protocol.
• Considered a candidate for shoulder arthroplasty using a study device.

Key Exclusion Criteria

• Patients who are not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times).
• Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred to as a "vulnerable subject" in section 3.44 of the ISO 14155:2020).
• Active local or systemic infection, sepsis, or osteomyelitis

Azael Arizpe, MD

PROVECRC 

Study Status: Enrolling

Collection of Samples from the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance

The Sponsor has identified cfDNA (circulating free-DNA) alterations (including methylation, fragmentation, and copy-number variance) that allow specific detection of colorectal cancer (CRC) advanced pre-cancerous lesions (APL) and is in the process of developing a blood-based test for early detection of colorectal cancer. The Sponsor is performing the current study to evaluate and optimize the performance of a preliminary panel of markers to finalize the assay for the use for US population. This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.

Key Inclusion Criteria

• Subject is 45- 84 years of age.
• Have a clinical or pathological confirmation of colorectal cancer diagnosis.
• Is treatment naive.
• Able to comprehend, sign, and date the written consent document.

Key Exclusion Criteria

• Patient with curative biopsy during colonoscopy.
• Patient underwent any cancer related treatment.
• Patient had a colonoscopy less than 3 days prior to blood sample collection.
• Patient has gone through complete CRC tumor removal, prior to enrollment.
• History of colorectal cancer.

David Smith, MD

IMPACT CRC

Study Sponsor: Exact Sciences Corp.

Study Status: Enrolling

Specimen Collection from Participants Due for Colorectal Cancer Screening, Surveillance, or Treatment: IMPACT

To collect de-identified, clinically characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays and devices for early detection of colorectal neoplasia.

Key Inclusion Criteria

• Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant personally identifiable information (PII).
• Participant is willing to provide all specimen(s) as requested.

Key Exclusion Criteria

• Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) or cancer-related treatment (e.g., chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years. (Note for Cohort 2: “previous cancer diagnosis” refers to diagnosis prior to their current condition.)
• Participant has any condition that in the opinion of the Investigator should preclude participation in the study.
• Participant has enrolled in any other Exact Sciences study within the past year or has previously enrolled in this study.

David Smith, MD

NCT03499236: RELIEVE HF

Study Sponsor: V-Wave Ltd.

Study Status: Closing

RELIEVE-HF TRIAL: Reducing Lung CongestIon Symptoms In Advanced Heart Failure

The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

Stanislav Weiner, MD

NCT05855135: Integra-D

Study Sponsor: Impulse Dynamics

Study Status: Enrolling

Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects with Heart Failure and Reduced Ejection Fraction

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%).

Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.

Key Inclusion Criteria

• Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure
• Patient has HFrEF (LVEF ≤40%)
• Patient is on GDMT for heart failure
• Patient has a Class I or Class II indication for an ICD
• Patient has a reasonable expectation of meaningful survival of > 1 year

Key Exclusion Criteria

• Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR
• Patients who have undergone mitral valve repair or clip within 90 days prior to study consent
• Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent

Stanislav Weiner, MD

CARVTOP-ICD

Study Sponsor: Patient Centered Outcomes Research Institute (PCORI)

Study Status: Enrolling

Comparative Effectiveness of Carvedilol versus Metoprolol Succinate in Heart Failure Patients with an Implantable Cardioverter Defibrillator (CARVTOP-ICD)

Key Inclusion Criteria

• Age ≥18 years (no upper limit)
• ICD implanted for primary prevention for HFrEF (either ICM or NICM) with remote monitoring capability
• Current treatment with metoprolol succinate and willing to switch to carvedilol
• LVEF <50% during the past 12 months prior to consent

Key Exclusion Criteria

• Unwilling or unable to follow the protocol
• Treatment with any other beta-blocker (βB) than metoprolol succinate or no βB treatment
• Known prior intolerance or contraindication to carvedilol
• Systolic blood pressure <100 mmHg
• Enrollment in another clinical trial
• Inability or unwillingness to consent

NCT06118281: ARTEMIS

Study Sponsor: Novo Nordisk A/S

Study Status: Enrolling

ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in their stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

Key Inclusion Criteria

• Age ≥18 years
• • Hospitalization for acute myocardial infarction with evidence of type 1 myocardial infarction (MI) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities. OR
• Non-ST-segment myocardial infarction with all the following: a) Relevant onset of symptoms suggestive of cardiac ischemia within 24 hours before hospitalization, at the investigator's discretion. b) Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit.
• Possibility for both randomization and administration of the loading dose of study intervention as early as possible after invasive procedure, and latest within 36 hours of hospitalization (time 0) for STEMI, and latest within 72 hours of hospitalization (time 0) for NSTEMI.

Key Exclusion Criteria

• Use of fibrinolytic therapy for treatment of the current AMI.
• Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV.
• Ongoing haemodynamic instability defined as any of the following: a) Killip Class III or IV. b) Sustained and/or symptomatic hypotension (systolic blood pressure less than 90 millimeters of mercury (mmHg)).
• Severe kidney impairment defined as any of the following: a) eGFR less than 15 mililitre per minute per 1.73 m^2. b) Chronic haemodialysis or peritoneal dialysis.
• Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal (reference range) (ULN).

NCT03970343: OPTIMIZER PAS

A Prospective, Multi-center, Non-randomized, Single Arm Open Label Study of 620 Subjects Receiving the OPTIMIZER Smart with CCM Therapy As Standard of Care

The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%

Key Inclusion Criteria

• Male or non-pregnant female, aged 18 or older
• Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
• NYHA Class III heart failure symptoms
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Patient has been treated with guideline-directed medical therapy

Key Exclusion Criteria

• Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
• IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
• Myocardial infarction within 90 days prior to implant
• Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
• Prior heart transplant or ventricular assist device

Stanislav Weiner, MD

NCT01524276: Medtronic PSR

Study Sponsor: Medtronic

Study Status: Enrolling

Medtronic Product Surveillance Registry

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading-edge performance assessment via the least burdensome approach.

Key Inclusion Criteria

• Patient has or is intended to receive or be treated with an eligible Medtronic product
• Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Key Exclusion Criteria

• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Stanislav Weiner, MD

NCT06307652: BalanceD-HF

Study Sponsor: AstraZeneca

Study Status: Start up

A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function

This is a Phase III, international, multi-centre, randomized, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

Key Inclusion Criteria

• Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
• Having had a recent HF event within 6 months (hospitalization or urgent visit)
• Have a LVEF value from an assessment within the last 12 months
• Managed with SoC therapy for HF and renal impairment according to local guidelines

Key Exclusion Criteria

• Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
• Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or planned to undergo any of these operations
• History of hypertrophic obstructive cardiomyopathy
• Complex congenital heart disease or severe uncorrected primary valvular disease

NCT05988411: ULTRA HFIB Redo

Study Sponsor: Vivek Reddy

Study Status: Enrolling

Ultrasound-Based Renal Sympathetic Denervation As Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: a Pilot Study

This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Key Inclusion Criteria

• Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation, must have been completed). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.)
• History of hypertension and either: Documented history of SBP≥160 or DBP≥100, or; Receiving ≥1 antihypertensive medication;
• Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

Key Exclusion Criteria

• Long-standing persistent AF (>12 months); >3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium.
• Individual with valvular AF or AF due to a reversible cause
• Prior treatment with other devices for hypertension, including but not limited to ROX Coupler, Mobius stent, and/or the CVRx barostimulator device.
• NYHA class IV congestive heart failure;

Stanislav Weiner, MD

NCT06521463: SIMPLAAFY

Study Sponsor: Boston Scientific Corporation

Study Status: Enrolling

WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy

This study is a prospective, randomized, open-label, triple-arm, multi-center trial. Subjects will be randomized 1:1:1 to one of the three therapy arms and remain on treatment through the end of study (12 months):

• Aspirin only
• Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)
• DAPT

Key Inclusion Criteria

• Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use.
• Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms.
• The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
• The subject is able and willing to return for required follow-up visits and examinations.

Key Exclusion Criteria

• Subject's device implant procedure was aborted (i.e., failed implant).
• Subject has a device margin residual leak > 0mm at time of implant.
• Occurrence of complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure, post-procedure, or prior to randomization.

Stanislav Weiner, MD

NCT05963698: LAAOS-4

Study Sponsor: Hamilton Health Sciences Corporation

Study Status: Enrolling

The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)

LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

Key Inclusion Criteria

• (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
• Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. [Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).
• Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.

Key Exclusion Criteria

• Current left atrial appendage thrombus
• Prior left atrial appendage occlusion or removal (surgical or percutaneous)
• Prior percutaneous atrial septal defect or patent foramen ovale closure
• Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
• Planned atrial fibrillation ablation within 90 days of enrollment
• Individuals being treated with direct thrombin inhibitors

Stanislav Weiner, MD

NCT05905835: SENSATION

Study Sponsor: Synaptic Medical Corporation

Study Status: Active, Not Recruiting

Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System

A multi-center, open-label, prospective, single-arm, pre-market clinical study. Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure. Data will be collected at enrollment, procedure, discharge, 1, 3, 6 and 12- months to assess the safety and effectiveness of the System. Testing for recurrence of atrial fibrillation will include a 12-lead ECG at 1, 3, 6 and 12-months post-ablation, weekly event recorder transmissions after the 3- month follow-up visit through the 12-month follow up, and a 24-h continuous Holter ECG recording at 6 and 12-months post ablation. Symptom triggered rhythm monitoring will be used throughout the effectiveness post-ablation period.

Key Inclusion Criteria

• Diagnosis of symptomatic Paroxysmal Atrial Fibrillation (PAF), defined as atrial fibrillation that terminates spontaneously or with intervention (either through procedure or drug therapy) within seven (7) days of onset.
• Refractory or intolerant to at least one (1) Class I or III anti-arrhythmic medication or contraindicated to any class I or III medication.

Key Exclusion Criteria

• Diagnosis of persistent AF, i.e., continuous AF lasting longer than seven (7) days from onset
• History of previous left atrial ablation or surgical treatment for AF/AFL/AT
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
• Body Mass Index (BMI) ≥ 40
• Structural heart disease

Stanislav Weiner, MD

NCT06096337: AVANT GUARD

Study Sponsor: Boston Scientific Corporation

Study Status: Active, Not Recruiting

A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation

The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.

Stanislav Weiner, MD

NCT05809596: HEAL-LAA

Study Sponsor: Boston Scientific Corporation

Study Status: Active, Not Recruiting

HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device

The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.

Stanislav Weiner, MD

NCT04680026: HBIO

Study Sponsor: HUYABIO International, LLC

Study Status: Active, Not Recruiting

A Phase 2, Two-Stage, Serial Cohort Dose Escalation and Expansion Study of a Single Intravenous Infusion of HBI 3000 for the Conversion of Atrial Fibrillation (AF) of Recent Onset

This Phase 2 study is a two-stage, serial cohort dose escalation and expansion study of a single 30-minute (IV) infusion of HBI-3000 for the conversion of patients with recent-onset atrial fibrillation (AF).

Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts, up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). Three different dose levels are planned to be administered serially, lowest to highest, with assessment of safety, tolerability, and efficacy prior to proceeding to the next dose level group.

Following Stage A, the iDMC will recommend up to two doses of HBI-3000 to be further explored in Stage B. Stage B is a serial, randomized, double-blind and placebo-controlled cohort of two different doses of HBI-3000, with a dose decision after the first cohort. Stage B will be powered to show a difference between HBI-3000 and placebo in conversion rate at each of the two dose levels.

Stanislav Weiner, MD

NCT05147792: CONFORM

Study Sponsor: Conformal Medical, Inc.

Study Status: Enrolling

An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion

The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.

Key Inclusion Criteria

• Male or non-pregnant female aged ≥18 years
• Documented non-valvular AF (paroxysmal, persistent, or permanent)
• High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
• Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation

Key Exclusion Criteria

• Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
• Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO/ASD closure device, history of surgical ASD repair or history of surgical LAAO closure)
• Atrial fibrillation that is defined by a single occurrence or that is transient or reversible

Stanislav Weiner, MD

NCT05478304: LeAAPS

Study Sponsor: AtriCure, Inc.

Study Status: Active, Not recruiting

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Key Inclusion Criteria

• Documentation of any of the following clinical criteria:
  • CHA2DS2-VASc ≥ 4 with age ≥ 65
  • CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
  • CHA2DS2-VASc = 3 with age ≥ 75
  • CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
  • CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP

Key Exclusion Criteria

• Clinically significant atrial fibrillation or atrial flutter:
  • Anytime in the past and
  • Documented by an electrocardiographic recording and
  • Episode lasting 6 minutes or longer
• Prior procedure involving opening the pericardium or entering the pericardial space
• Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
• Planned cardiac surgical procedure using non-sternotomy approaches
  • Partial sternotomies will be allowed.
• Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
• Active endocarditis

James Caccitolo, MD

NCT05712200: LILAC

Study Sponsor: Anthos Therapeutics, Inc.

Study Status: Enrolling

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)

A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.

Key Inclusion Criteria

• Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
• Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3
• Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study
• At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls

Key Exclusion Criteria

• AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
• Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF
• Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
• Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization
• Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
• Patients on dialysis at screening or who are planned to start dialysis within 6 months

Stanislav Weiner, MD