Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04704219
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab 400 mg, every 6 weeks (Q6W) intravenous (IV) up to 18 infusions or up to progressive disease or discontinuation.
  • Lenvatinib — DRUG
    Lenvatinib 20 mg, daily (QD), oral, until progressive disease or discontinuation.

Study Details

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.

Key Dates

Start date
Feb 23, 2021
Status verified
Nov 2025
Primary completion
Jan 27, 2025
Completion
Oct 21, 2025

Study Design

Enrollment
160 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Lenvatinib
    Pembrolizumab 400 mg, every 6 weeks (Q6W) intravenous (IV) up to 18 infusions or up to progressive disease or discontinuation PLUS Lenvatinib 20 mg, daily (QD), oral, until progressive disease or discontinuation.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 47 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Georgetown University Medical Center ( Site 0001)Washington D.C.District of Columbia20007-
St. Vincent Frontier Cancer Center ( Site 0004)BillingsMontana59102-
Comprehensive Cancer Centers of Nevada ( Site 0010)Las VegasNevada89169-
Memorial Sloan Kettering Cancer Center ( Site 0015)New YorkNew York10065-
Fox Chase Cancer Center ( Site 0011)PhiladelphiaPennsylvania19111-
Vanderbilt University Medical Center ( Site 0008)NashvilleTennessee37232-
Seattle Cancer Care Alliance ( Site 0014)SeattleWashington98109-
MEDICAL COLLEGE OF WISCONSIN ( Site 0006)MilwaukeeWisconsin53226-

Related coverage on Hipa.ai

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