Trials / Active Not Recruiting
Active Not RecruitingNCT04626518
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B in Second-Line Metastatic Participants
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 370 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
Substudy 03B 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 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) 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 200 mg Q3W or 400 mg Q6W |
| BIOLOGICAL | MK-4830 | Administered via IV infusion at a dose of 800 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 |
| BIOLOGICAL | Favezelimab/Pembrolizumab | Administered via IV infusion at a dose of 800 mg/200 mg Q3W |
Timeline
- Start date
- 2020-12-17
- Primary completion
- 2026-05-31
- Completion
- 2026-05-31
- First posted
- 2020-11-12
- Last updated
- 2025-07-25
Locations
51 sites across 13 countries: United States, Australia, Canada, Chile, France, Hungary, Israel, Netherlands, New Zealand, Poland, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04626518. Inclusion in this directory is not an endorsement.