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Joint Clinical Trials Office

A Randomized, Phase III Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First-line Treatment of HER2-positive Gastric Cancer

This clinical trial is designed for men and women with HER2 positive gastric cancer.
   

A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of BHV-1510 (Previously PBI-410) as Monotherapy and in Combination with Anti-Cancer Agents in Participants with Advanced Solid Tumors

This study is being done to evaluate the safety and potential effectiveness of BHV-1510 alone and BHV-1510 in combination with cemiplimab in participants with certain solid tumor cancers. This study will be conducted in 2 parts called “phases.”

A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy with Lumen-Apposing Metal Stent for Gastric Outlet Obstruction from Malignant Unresectable Disease

This study is for female and male patients who are 18 years of age and older and have Gastric Outlet Obstruction (GOO). GOO is the inability of the stomach to empty its contents into the duodenum.

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection (ECLIPSE 1)

The primary objective of the study is to evaluate the safety of tobevibart+elebsiran in participants with chronic hepatitis Delta virus (HDV) infection. 

Checking In: The Role of Sleep in Cardiovascular Health Among Men Living with HIV

The purpose of this study is to learn more about the daily experiences, including thoughts, feelings, social interactions, medication adherence, and overall health and well-being of gay or bisexual men living with HIV ages 45-64.

There are three study visits:

  1. Day 1/screening visit
  2. 6 month visit
  3. 12 month visit.

Participation will last about 12 months. After the Day 1 study visit, participants are asked to complete a daily diary survey and wear a watch that measures sleep and activity for 30 days.  

A Phase 3b, open label, randomized, standard-of-care control arm, multicenter, superiority study evaluating the efficacy, safety and tolerability of injectable CAB LA + RPV LA in viremic participants living with HIV-1 (CROWN)

The purpose of this study is to evaluate a potential long-acting injectable HIV treatment option for people whose HIV is not undetectable.

The study drug is a long-acting HIV treatment. It is given by injection every other month after 2 started doses. This is in contrast to oral ART, which is designed to be taken daily.

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States

The purpose of this study is to advance HIV prevention research for women in the United States, explore whether cisgender women prefer getting injections of Lenacapavir (LEN) or taking Truvada (F/TDF) pills.

Participants will be randomized into one of two groups. Randomized means the study treatment will be chosen by chance—like flipping a coin.

Group 1 will receive LEN injection on Day 1 and Week 26.   Participants in this group will also receive 4 tablets of a loading dose of LEN to take on Days 1 and 2 (two tablets each day).

A Phase 2 Crossover Study Of On-Demand Prep Formulations Comparing Rectal And Oral Tenofovir-Based Prep Evaluating Extended Safety, Acceptability, And Pharmacokinetics/Pharmacodynamics

This study is comparing rectal and oral Tenofavir-based prep. The rectal study product is a rectal douche, or enema, that contains the anti-HIV drug tenofovir (TFV). The other study product is taken by mouth and is a combination of two drugs, called emtricitabine (FTC or F) and tenofovir disoproxil fumarate (TDF).

Tenofovir (TFV) rectal douche is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA). Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) is FDA-approved and used according to FDA labeling.

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer

This study examines which patients who have undergone surgical removal of bladder, kidney, ureter or urethra, require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back and if those patients can be identified by a blood test. This study also aims to find out if this approach is better or worse than the usual approach for urothelial cancer.

Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction (GORE REDEFINE Study, TBR 22-07)

This research study will look at breast reconstruction during mastectomy procedures. Data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device. The study will look at the safety of the study device and the success of the participants' breast reconstruction.

The TRBR Device is investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for this treatment.