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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4.5 years
Awards & highlights

KEYNOTE-B61 Trial 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).Check my eligibility
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.See study design
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.

KEYNOTE-B61 Trial 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.
Select...
My cancer is at stage IV.
Select...
My kidney cancer is not of the clear cell type.

KEYNOTE-B61 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Clinical Benefit Ratio (CBR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+4 more

KEYNOTE-B61 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 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690

Find a Location

Who is running the clinical trial?

Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,868 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,670 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,419 Total Patients Enrolled

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04704219 — Phase 2
Kidney Cancer Research Study Groups: Pembrolizumab + Lenvatinib
Kidney Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04704219 — Phase 2
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04704219 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively involved in this clinical experiment?

"This medical trial has since ceased recruitment of new patients; it was initially posted on the 23rd February 2021 and edited for the final time on 31st January 2022. Alternatively, there are 2,582 studies recruiting participants with carcinoma renal cell and 1,032 seeking individuals to participate in pembrolizumab trials."

Answered by AI

Has the FDA authorized Pembrolizumab as a viable treatment option?

"Pembrolizumab is classified as a "2" on the safety scale due to its Phase 2 status. This denotes that there are some data points affirming safety, but none yet verifying efficacy."

Answered by AI

How many locales are overseeing this experiment?

"A dozen sites are recruiting for this medical trial, including Memorial Sloan Kettering Cancer Center (Site 0015) in New york, Comprehensive Cancer Centers of Nevada (Site 0010) in Las Vegas, and BC Cancer Vancouver-Clinical Trials Unit ( Site 1500) in Vancouver."

Answered by AI

What maladies have been remedied through the use of Pembrolizumab?

"Pembrolizumab is frequently administered to combat malignant neoplasms, as well as unresectable melanoma, microsatellite instability high cases and chemotherapy-resistant progessions."

Answered by AI

Is the elderly population being considered for participation in this trial?

"This clinical trial only includes individuals aged 18 to 120. For those under the age of consent, there are 116 studies available and 3581 for elderly patients above 65 years old."

Answered by AI

Could you inform me of any prior research studies involving Pembrolizumab?

"Back in 2010, City of Hope was the first to explore pembrolizumab. Since then, 302 trials have been concluded and an additional 1032 studies are underway. With a concentration of these ongoing experiments based out of New york City."

Answered by AI

Who meets the criteria to be admitted into this research trial?

"This medical trial is seeking 152 individuals with renal cell carcinoma aged between 18 and 120. To be eligible, they must fulfill the following criteria: Present a histologically-confirmed diagnosis of non-clear cell RCC., Exhibit advanced/metastasized disease (i.e. Stage IV per AJC guidelines), Demonstrate adequately regulated blood pressure with or without antihypertensive medication, Have no prior systemic therapy for nccRCC within 12 months before recruitment (exception made in case of neoadjuvant/adjuvant treatment). Furthermore, male participants must agree to use contraception for at least 7 days after the last"

Answered by AI

Are there any opportunities currently available to join this experiment?

"According to the information hosted on clinicaltrials.gov, this research endeavour is not currently open for participant recruitment. This trial was initially made available February 23rd 2021 and last updated January 31st 2022; however, there are 3,614 other studies that presently seeking participants."

Answered by AI
~11 spots leftby Aug 2024