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HIF-2 Alpha Inhibitor

Belzutifan for Kidney Cancer

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 received no more than 3 prior systemic regimens for locally advanced or metastatic RCC

A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 27 months

Awards & highlights

Study Summary

This trial will compare the effectiveness of two doses of belzutifan in people with advanced kidney cancer that has spread after previous treatment. The higher dose is expected to be better in terms of tumor shrinkage.

Who is the study for?

This trial is for adults with advanced renal cell carcinoma who have previously been treated with anti-PD-1/L1 therapy. They must be in good physical condition (KPS score ≥70%), able to use contraception, and not pregnant or breastfeeding. Participants should have no more than three prior treatments for RCC, only one of which can be anti-PD-1/L1 therapy.Check my eligibility

What is being tested?

The study tests two different doses of belzutifan to see which one works better for treating advanced renal cell carcinoma after previous therapies. The main goal is to compare the objective response rates between the standard dose and a higher dose.See study design

What are the potential side effects?

Potential side effects of belzutifan may include fatigue, nausea, anemia (low red blood cells), hypoxia (low oxygen levels), and issues affecting liver function. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have had 3 or fewer treatments for advanced kidney cancer.

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I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control during and after the study.

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I am mostly able to care for myself and am up more than 50% of my waking hours.

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I am a man who will not have sex or will use birth control during and for 7 days after the study.

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My kidney cancer has spread and shows clear cell features.

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I have had one prior treatment with anti-PD-1/L1 for advanced kidney cancer.

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I have recovered from side effects of past treatments, except for mild nerve pain or hormone issues.

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My kidney cancer worsened after treatment with specific immune therapies.

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I can provide a sample of my tumor that hasn't been treated with radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 27 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

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Secondary outcome measures

Clinical Benefit Rate (CBR) Per RECIST 1.1 as Assessed by BICR

Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

Maximum Plasma Concentration (Cmax) of Belzutifan

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Belzutifan 200 mgExperimental Treatment1 Intervention

Participants receive 200 mg of belzutifan by oral administration, once a day (QD), until disease progression or discontinuation.

Group II: Belzutifan 120 mgExperimental Treatment1 Intervention

Participants receive 120 mg of belzutifan by oral administration, QD, until disease progression or discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belzutifan

2018

Completed Phase 1

~40

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,668 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,417 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,326 Total Patients Enrolled

Media Library

Belzutifan (HIF-2 Alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04489771 — Phase 2

Renal Cell Carcinoma Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT04489771 — Phase 2

Renal Cell Carcinoma Research Study Groups: Belzutifan 120 mg, Belzutifan 200 mg

Belzutifan (HIF-2 Alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04489771 — Phase 2

Frequently Asked Questions

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

Has Belzutifan been given the green light by the FDA?

"Our experts at Power judged belzutifan's safety to be a two, as it is in the second phase of testing with initial data showing its security but no evidence yet regarding effectiveness."

Answered by AI

What medical conditions is Belzutifan typically employed to address?

"Belzutifan is a viable treatment for malignant neoplasms, anemia, sickle cell disease, and von Hippel-Lindau syndrome."

Answered by AI

Is this an unprecedented research venture?

"Since first being studied in 2016, Belzutifan has been carefully researched. Initially sponsored by Peloton Therapeutics, Inc., the initial clinical trial involved 120 patients and led to Phase 1 drug approval. Currently there are 16 active studies investigating its efficacy across 372 cities and 44 countries worldwide."

Answered by AI

What is the geographic scope of this investigative research?

"This medical experiment is presently seeking participants from 19 distinct sites, including Dallas, Philadelphia and Albany. To receive the full benefits of participating in this trial, it's advisable to select a site close to you so travelling demands are minimized."

Answered by AI

What is the aggregate count of individuals partaking in this research?

"This clinical trial has ceased recruiting participants. Initially posted on September 13th 2020 and last edited July 8th 2022, the study has concluded its patient recruitment phase. If you are looking for a different medical trial, there are 2580 studies currently enrolling patients with carcinoma renal cell and 16 trials offering Belzutifan treatment which have yet to meet their participant quota."

Answered by AI

What evidence has been collected regarding Belzutifan through prior experiments?

"At the time of writing, there are 16 trials researching Belzutifan with 3 in their terminal phase. Despite being headquartered in Cardiff, Wales, 859 locations worldwide have elected to participate in these studies."

Answered by AI

Does this research endeavor currently accept participants?

"Unfortunately, this research is not presently recruiting any more participants. Originally posted on September 13th 2020 and last edited July 8th 2022; those seeking other medical studies may find solace in the 2580 trials actively enrolling patients with carcinoma, renal cell or 16 Belzutifan specific clinical trials that are currently searching for individuals to join them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)

2020. "A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04489771.

All > Renal Cell Carcinoma