At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 160 enrolled
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Pembrolizumab 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab and Lenvatinib for Renal Cell Carcinoma. Completed, enrolled 160 participants across 56 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesAustralia, Canada, France, Hungary, Ireland, Italy, Poland, Russia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsEisai Inc.
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJan 2021
Enrollment StartFeb 2021
Primary CompletionJan 2025
Study CompletionOct 2025
TodayJul 2026
First PostedJan 11, 2021
Enrollment StartFeb 23, 2021
Primary CompletionJan 27, 2025
Study CompletionOct 21, 2025
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 5.5 years ago
Interventions
Pembrolizumabbiological
Pembrolizumab 400 mg, every 6 weeks (Q6W) intravenous (IV) up to 18 infusions or up to progressive disease or discontinuation.
Lenvatinibdrug
Lenvatinib 20 mg, daily (QD), oral, until progressive disease or discontinuation.