KEYNOTE-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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18-120Age 18-120

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Systemic therapy | Urinary systemRenal cell carcinoma

Trial Overview Read MoreRead more

This Phase II trial is trying to understand the potential benefits of immunotherapy (pembrolizumab) in combination with targeted therapy (lenvatinib) in people with previously untreated advanced or metastatic non-clear cell renal cell carcinoma.
 

This trial is treating patients with non-clear cell renal cell carcinoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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)

Commercial Sponsor

Merck

Summary

This is a single-arm, open label trial. All participants will receive pembrolizumab + lenvatinib. Pembrolizumab (400mg) will be administered every 6 weeks (Q6W) via intravenous infusions up to 18 infusions or up to progressive disease or discontinuation. Lenvatinib (20mg) will be administered daily (QD) orally, until progressive disease or discontinuation.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Genitourinary Research Study Coordinator
gu.oncresearch@monashhealth.org
0436387664

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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