Pembrolizumab + Lenvatinib for Kidney Cancer
(KEYNOTE-B61 Trial)

Recruiting in Palo Alto (17 mi)

+55 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with advanced/metastatic non-clear cell renal cell carcinoma who haven't had systemic therapy for it. They must have a confirmed diagnosis, measurable disease, good performance status (KPS ≥70%), and adequate organ function. Women of childbearing potential must agree to contraception during treatment and afterwards (120 days post pembrolizumab or 30 days post lenvatinib).

Inclusion Criteria

My organs are functioning well.

My cancer can be measured and has grown in areas previously treated with radiation.

My cancer is at stage IV.

See 7 more

Exclusion Criteria

My heart's pumping ability is below the normal range.

I have coughed up bright red blood recently.

My kidney cancer is of a type called collecting duct.

See 21 more

Treatment Details

Interventions

Lenvatinib (Tyrosine Kinase Inhibitor)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe study tests the combination of two drugs, Pembrolizumab and Lenvatinib, in patients with untreated kidney cancer that has spread. It's an open-label study where all participants receive the same treatment to quickly assess its benefits.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions

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.

Lenvatinib is already approved in United States, European Union, European Union for the following indications:

🇺🇸 Approved in United States as Lenvima for: