Trials / Active Not Recruiting
Active Not RecruitingNCT04626479
Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A in First Line Metastatic Participants
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | Administered via IV infusion at a dose of 400 mg Q6W |
| BIOLOGICAL | Favezelimab/Pembrolizumab | Administered via IV infusion at a dose of 800 mg/200 mg Q3W |
| DRUG | Belzutifan | Administered via oral tablet at a dose of 120 mg QD |
| DRUG | Lenvatinib | Administered via oral capsule at a dose of 20 mg QD |
| BIOLOGICAL | Pembrolizumab/Quavonlimab | Administered via IV infusion at a dose of 400 mg/25 mg Q6W |
| DRUG | Vibostolimab/Pembrolizumab | Administered via IV infusion at a dose of 200 mg/200 mg Q6W |
Timeline
- Start date
- 2020-12-16
- Primary completion
- 2026-05-31
- Completion
- 2026-05-31
- First posted
- 2020-11-12
- Last updated
- 2026-02-12
Locations
55 sites across 14 countries: United States, Australia, Canada, Chile, Colombia, France, Hungary, Israel, Netherlands, New Zealand, Poland, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04626479. Inclusion in this directory is not an endorsement.