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HIF-2alpha Inhibitor
Belzutifan + Lenvatinib vs. Cabozantinib for Kidney Cancer
Phase 3
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
Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC)
Adequately controlled blood pressure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 44 months
Awards & highlights
Study Summary
This trial will compare the effectiveness of two different drugs for people with a specific type of kidney cancer.
Who is the study for?
This trial is for adults with advanced renal cell carcinoma who have seen their cancer progress after anti-PD-1/L1 therapy. They should have measurable disease, a Karnofsky performance status of at least 70%, and no more than two prior systemic treatments. Participants must not be pregnant or breastfeeding and agree to use contraception.Check my eligibility
What is being tested?
The study tests the effectiveness of combining Belzutifan with Lenvatinib against Cabozantinib alone in treating renal cell carcinoma. The main goal is to see if the combination leads to longer survival without cancer progression compared to Cabozantinib.See study design
What are the potential side effects?
Potential side effects include high blood pressure, fatigue, nausea, diarrhea, decreased appetite, weight loss, vomiting, constipation, and joint/muscle pain. There may also be risks related to liver function changes and protein levels in urine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer cannot be surgically removed and has spread.
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My blood pressure is under control.
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I have had 2 or fewer previous treatments for my condition.
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My kidney cancer worsened after PD-1/L1 therapy.
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My kidney cancer cannot be removed by surgery and has spread.
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I am mostly independent and can care for myself.
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I am mostly able to care for myself but may not be able to do active work.
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I have had one prior treatment with antiPD-1/L1 for kidney cancer.
Select...
My kidney cancer worsened after PD-1/L1 therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 44 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 44 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experienced One or More Adverse Events (AEs)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Belzutifan + LenvatinibExperimental Treatment2 Interventions
Belzutifan 120 mg and lenvatinib 20 mg orally once a day
Group II: CabozantinibActive Control1 Intervention
Cabozantinib 60 mg orally once a day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
2018
Completed Phase 1
~40
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,427 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,059,227 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
158,263 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are working well.Your disease can be measured using a specific set of criteria called RECIST 1.1 by the study doctor in your area.Your heart's electrical activity takes too long, more than 480 milliseconds.I am currently being treated for an infection.I have not had significant bleeding in the last 3 months.I am a man who will not have sex or will use birth control during and after the treatment.I have had a solid organ transplant.I cannot take pills by mouth or have a condition that affects how my body absorbs medication.My kidney cancer cannot be surgically removed and has spread.I have been treated with cabozantinib before.I've had up to 2 treatments for my cancer, including one that targeted PD-1/L1.My blood pressure is under control.I have had one prior treatment with antiPD-1/L1 for my kidney cancer.I have a severe fistula.I have been treated with lenvatinib before.I have a history of HIV infection.I am not pregnant or breastfeeding and agree to follow the contraceptive guidelines if applicable.I haven't had active treatment for another cancer, except skin or in situ cancers, in the last 3 years.My liver is not working well.I have had hepatitis B or currently have hepatitis C.I have had 2 or fewer previous treatments for my condition.My cancer has spread to my brain or spinal cord.My kidney cancer worsened after PD-1/L1 therapy.My kidney cancer cannot be removed by surgery and has spread.I have fluid in my chest causing symptoms like coughing or trouble breathing.I haven't had serious heart problems in the last 6 months.I have been treated with belzutifan or a similar drug before.I am mostly independent and can care for myself.I need extra oxygen sometimes or all the time.I have not taken any colony-stimulating factors in the last 28 days.Your disease can be measured using specific criteria by the local study investigator.I am mostly able to care for myself but may not be able to do active work.I have had one prior treatment with antiPD-1/L1 for kidney cancer.My kidney cancer worsened after PD-1/L1 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib
- Group 2: Belzutifan + Lenvatinib
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the possible negative health effects of taking Belzutifan?
"Belzutifan has received a safety score of 3. This is due to the fact that it is in Phase 3 clinical trials, meaning that there is some evidence supporting its efficacy as well as multiple rounds of data affirming its safety."
Answered by AI
What are the clinical goals of this research study?
"The primary goal of this study, which will last for approximately 34 months, is to monitor the Overall Survival (OS) of patients. Additionally, researchers will track secondary outcomes including the Objective Response Rate (ORR), Duration of Response (DOR), and number of participants who need to discontinue study treatment due an Adverse Event (AE)."
Answered by AI
Has this sort of treatment been done before?
"Research into Belzutifan began in 2012 with a study sponsored by Exelixis. This initial trial had 86 participants and following its success, the medication received Phase 2 drug approval. At present, there are 272 active trials for Belzutifan taking place in 2009 cities across 56 countries."
Answered by AI
Are people with the required criteria able to sign up for this research project?
"Indeed, this trial is still recruiting patients according to the latest update on clinicaltrials.gov from November 11th, 2021. The posting for the trial went up on February 25th, 2021."
Answered by AI
What health concerns does Belzutifan address?
"While it is typically given to patients who have already tried anti-VEGF treatments, belzutifan can also be used as a first line of defense for high risk patients or those with renal cell carcinoma and sorafenib."
Answered by AI
Are there any similar drugs to Belzutifan that have been studied in the past?
"The drug known as Belzutifan was first researched in 2012 at the Memorial Sloan Kettering Commack. In total, there have been one hundred and eight completed studies thus far. Currently, there are two hundred and seventy-two actively recruiting clinical trials; a majority of these taking place in Seattle, Washington."
Answered by AI
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