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HIF-2 Alpha Inhibitor
Belzutifan vs Everolimus for Renal Cell Carcinoma
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
Has had disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with both Programmed cell death 1 ligand 1 (PD-1/L1) checkpoint inhibitor and a vascular endothelial growth factor - tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
Has unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 49 months
Awards & highlights
Study Summary
This trial is comparing two cancer drugs to see which one is more effective in terms of survival rate and progression-free survival.
Who is the study for?
This trial is for adults with advanced renal cell carcinoma who've had no more than three prior treatments, are not pregnant or breastfeeding, and agree to use contraception. They must have progressed after treatment with specific cancer drugs (PD-1/L1 inhibitors and VEGF-TKIs) and have good organ function. Exclusions include other active cancers within 3 years, brain metastases, significant heart issues, allergies to the study drugs, recent major surgery or certain medications.Check my eligibility
What is being tested?
The study aims to see if Belzutifan improves survival without cancer progression compared to Everolimus in patients with advanced kidney cancer. It's a head-to-head comparison of these two drugs' effectiveness over time.See study design
What are the potential side effects?
Possible side effects of Belzutifan and Everolimus may include fatigue, nausea, decreased appetite, changes in blood counts leading to increased risk of infections or bleeding problems; high blood pressure; mouth sores; skin rash; abnormal liver tests suggesting liver injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer worsened after treatment with PD-1/L1 and VEGF-TKI.
Select...
My kidney cancer cannot be surgically removed and has spread.
Select...
I have had 3 or fewer treatments for advanced kidney cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 49 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 49 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 Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
Change From Baseline in Disease Symptoms Using the FKSI-DRS Items 1-9 Score
Change From Baseline in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BelzutifanExperimental Treatment1 Intervention
Participants receive 120 mg of belzutifan orally once daily (QD)
Group II: EverolimusActive Control1 Intervention
Participants receive 10 mg of Everolimus orally once daily (QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
2018
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,547 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,238 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,128 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take pills by mouth or have a condition that affects how my body absorbs medication.I haven't had any cancer treatment with antibodies in the last 4 weeks.I have not had major surgery in the last 3 weeks.I am not pregnant or breastfeeding and, if able to have children, I agree to use contraception as advised.I have brain metastases or cancer in the lining of my brain but have been stable for at least 4 weeks.My kidney cancer worsened after treatment with PD-1/L1 and VEGF-TKI.I have not received a live vaccine in the last 30 days.I have not had active treatment for another cancer, except for certain skin cancers or localized cancers, in the last 3 years.I do not have severe heart problems like recent heart attacks or advanced heart failure.I have been treated with belzutifan or a similar drug before.I have been treated with drugs targeting specific cancer pathways before.You have been diagnosed with HIV, or you may need to get tested for HIV based on local health guidelines.I have active tuberculosis.My kidney cancer cannot be surgically removed and has spread.I am currently being treated for an infection.I am taking strong or moderate medication that affects liver enzymes and cannot stop during the study.I have a history of Hepatitis B or active Hepatitis C.You are allergic to the main ingredient or any part of the study drugs belzutifan or everolimus.I am taking medication that strongly or moderately affects liver enzymes and cannot stop during the study.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have had 3 or fewer treatments for advanced kidney cancer.My organs are functioning well.Your blood pressure is consistently too high, with a systolic blood pressure of 150 or higher and/or a diastolic blood pressure of 90 or higher.I had radiotherapy less than 2 weeks ago.I am a man who will not have sex or will use birth control during and for 7 days after the study.My liver is not working well (moderate to severe issues).
Research Study Groups:
This trial has the following groups:- Group 1: Everolimus
- Group 2: Belzutifan
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.
How many people are allowed to take part in this experiment?
"This particular trial is not currently looking for new patients, though this may change in the future. This study was first made public on February 27th, 2020 and was last updated on July 28th, 2022. There are presently 2652 studies actively admitting patients with carcinoma, renal cell and 114 studies for Belzutifan actively recruiting participants."
Answered by AI
Has Belzutifan undergone FDA testing for efficacy and safety?
"There is some efficacy data as well as multiple rounds of data supporting safety, Belzutifan received a score of 3."
Answered by AI
What is the clinical data that has been gathered on Belzutifan to date?
"The first trial for Belzutifan was completed over a decade ago, in 2008. Since then, there have been a total of 404 studies. Right now, there are 114 studies in progress. The majority of these active trials are based in Birmingham, Alabama."
Answered by AI
Could you please explain the most common medical procedures that utilize Belzutifan?
"Belzutifan is most often used as an immunosuppressant to prevent organ transplant rejection. Additionally, it has shown efficacy in treating cancer, waldenstrom macroglobulinemia, and lung conditions."
Answered by AI
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