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Tyrosine Kinase Inhibitor

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

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has measurable disease per RECIST 1.1 as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions

Has locally advanced/metastatic disease (ie, Stage IV per the American Joint Committee on Cancer)

Must not have

Has a left ventricular ejection fraction below the institutional (or local laboratory) normal range

Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment on people who haven't been treated before to see if it's effective.

Who is the study for?

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).

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include high blood pressure which needs monitoring or medication; fatigue; digestive issues like nausea or diarrhea; liver problems; changes in thyroid hormone levels; risk of bleeding or clotting disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My cancer is at stage IV.

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My kidney cancer is not of the clear cell type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have coughed up bright red blood recently.

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My kidney cancer is of a type called collecting duct.

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I have received an organ or tissue transplant from another person.

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I have an active tuberculosis infection.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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My cancer is affecting a major blood vessel or has caused a cavity within the tumor.

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I have had serious heart problems in the last year.

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I have been treated with specific immune therapy for cancer.

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I have a history of Hepatitis B or active Hepatitis C.

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I have or had lung inflammation that needed steroids.

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I have active brain metastases or cancer in the lining of my brain.

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I have a condition that affects how my body absorbs medication.

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I am currently being treated for an infection.

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I have been treated for an autoimmune disease in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Clinical Benefit Ratio (CBR)

Disease Control Rate (DCR)

Duration of Response (DOR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Lenvatinib

2017

Completed Phase 4

~2070