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HIF-2alpha Inhibitor

Belzutifan for Kidney Cancer

Phase 1
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 a histologically-confirmed diagnosis of unresectable, locally advanced/metastatic RCC with clear cell component (with or without sarcomatoid features) (may include participants with a diagnosis of von Hippel-Lindau [VHL] associated ccRCC)
Has experienced disease progression on or after having received at least one previous systemic treatment for advanced ccRCC
Screening 3 weeks
Treatment Varies
Follow Up up to ~49.5 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new drug for people with kidney cancer that has spread. They want to see if it is safe and how it affects the body.

Who is the study for?
This trial is for adults with advanced clear cell renal cell carcinoma who've had disease progression after at least one systemic treatment. They must have good organ function, agree to use contraception, and not be pregnant or breastfeeding. Exclusions include those with hypoxia, other active cancers within 3 years (except certain skin/in situ cancers), HIV/hepatitis infections, prior belzutifan treatment, recent anticancer antibodies or radiotherapy, major surgery within 3 weeks, brain metastasis, severe heart/liver conditions or infections.Check my eligibility
What is being tested?
The study tests the safety and effects of different doses of Belzutifan in patients with advanced kidney cancer as a second-line treatment. It aims to understand how the body handles the drug (pharmacokinetics) and its tolerability when given after another therapy has failed.See study design
What are the potential side effects?
While specific side effects for Belzutifan are not listed here, similar drugs may cause fatigue, nausea, liver issues like increased enzymes indicating damage or inflammation; anemia; decreased appetite; changes in taste; coughing; shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My kidney cancer cannot be surgically removed and has spread.
My kidney cancer has worsened after at least one treatment.
My organs are functioning well.
I am a male willing to use contraception or abstain from sex during and 7 days after the study.
I am not pregnant, breastfeeding, and if able to have children, I am using contraception or abstaining from sex.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~49.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~49.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Discontinue Study Treatment Due to an AE
Percentage of Participants Who Experience at Least One Adverse Event (AE)
Percentage of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)
+1 more
Secondary outcome measures
Area Under the Plasma Concentration Time Curve (AUC) of Belzutifan
Maximum Observed Plasma Concentration (Cmax) of Belzutifan
Minimum Observed Plasma Concentration (Cmin) of Belzutifan

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Belzutifan 200 mg TIDExperimental Treatment1 Intervention
Participants will receive belzutifan 200 mg orally TID. Treatment will continue until progressive disease or discontinuation.
Group II: Belzutifan 160 mg TIDExperimental Treatment1 Intervention
Participants will receive belzutifan 160 mg orally three times daily (TID). Treatment will continue until progressive disease or discontinuation.
Group III: Belzutifan 160 mg BIDExperimental Treatment1 Intervention
Participants will receive belzutifan 160 mg orally twice daily (BID). Treatment will continue until progressive disease or discontinuation.
Group IV: Belzutifan 120 mg QDExperimental Treatment1 Intervention
Participants will receive belzutifan 120 mg orally once daily (QD). Treatment will continue until progressive disease or discontinuation.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,610 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,844 Previous Clinical Trials
5,045,843 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,754 Previous Clinical Trials
8,058,472 Total Patients Enrolled

Media Library

Belzutifan (HIF-2alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04846920 — Phase 1
Renal Cell Carcinoma Research Study Groups: Belzutifan 160 mg BID, Belzutifan 160 mg TID, Belzutifan 200 mg TID, Belzutifan 120 mg QD
Renal Cell Carcinoma Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT04846920 — Phase 1
Belzutifan (HIF-2alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04846920 — Phase 1

Frequently Asked Questions

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

How many participants has the clinical trial enrolled thus far?

"Yes indeed, the information on clinicaltrials.gov specifies that recruitment for this experiment is in progress. It was published on June 14th 2021 and edited lastly on June 23rd 2022 with a requirement of 52 participants from 4 distinct medical sites."

Answered by AI

Has the FDA granted clearance for Belzutifan?

"Due to its Phase 1 designation, Belzutifan has only limited clinical data on both safety and efficacy prompting us at Power to rate it a score of 1."

Answered by AI

What is the number of medical facilities that are currently administering this trial?

"This research is recruiting patients at the University of Michigan in Ann Arbor, Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Centre in Nashville, and the MD Anderson Cancer Centre's Genitourinary Oncology Department. There are several other sites as well."

Answered by AI

Are there any opportunities to join this research project currently available?

"Affirmative. The information on clinicaltrials.gov confirms that this study is presently recruiting; the original post was dated June 14th 2021 and it underwent an update as recently as June 23rd 2022. This experiment requires 52 volunteers from 4 diverse sites to participate."

Answered by AI

What condition is Belzutifan commonly used to alleviate?

"Belzutifan has been medically proven to help tackle malignant neoplasms, anemia, sickle cell disease and the inherited disorder von Hippel Lindau."

Answered by AI

Could you detail any other investigations conducted on Belzutifan?

"Currently, the investigation of Belzutifan is being conducted in 16 different studies. Out of these experiments, three are actively recruiting subjects and have reached Phase 3. Although most research sites are located in Cardiff, Wales there exist 859 medical facilities running trials for this treatment."

Answered by AI

Is this a pioneering or unprecedented research endeavor?

"Research into Belzutifan began in 2016, and the initial study was sponsored by Peloton Therapeutics, Inc. In this original trial 120 patients were involved which allowed for a Phase 1 drug approval to be issued. As of now 16 trials are ongoing within 44 countries across 372 cities worldwide."

Answered by AI
~17 spots leftby Jul 2025