Trials / Completed
CompletedNCT04704219
Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)
A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants With First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | Pembrolizumab 400 mg, every 6 weeks (Q6W) intravenous (IV) up to 18 infusions or up to progressive disease or discontinuation. |
| DRUG | Lenvatinib | Lenvatinib 20 mg, daily (QD), oral, until progressive disease or discontinuation. |
Timeline
- Start date
- 2021-02-23
- Primary completion
- 2025-01-27
- Completion
- 2025-10-21
- First posted
- 2021-01-11
- Last updated
- 2025-12-03
- Results posted
- 2025-12-03
Locations
56 sites across 14 countries: United States, Australia, Canada, France, Hungary, Ireland, Italy, Poland, Russia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04704219. Inclusion in this directory is not an endorsement.