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HIF-2 Alpha Inhibitor

Belzutifan + Pembrolizumab for Kidney Cancer

Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 89 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help prevent ccRCC from coming back after surgery.

Who is the study for?
This trial is for adults who've had kidney cancer surgery within the last 12 weeks. They should have a certain level of risk for their cancer returning but no current evidence of disease spread, and must be in good physical condition (ECOG 0-1). Participants need proper organ function and can't join if they've had major recent surgeries, severe heart issues, active infections or autoimmune diseases, other cancers within 3 years, or specific lung conditions.Check my eligibility
What is being tested?
The study tests if taking belzutifan pills with pembrolizumab injections works better than placebo pills with pembrolizumab for preventing kidney cancer from coming back after surgery. The main goal is to see which combination leads to longer periods without the disease returning.See study design
What are the potential side effects?
Possible side effects include immune system reactions that could affect organs like lungs or intestines, fatigue, skin problems, hormonal gland issues (like thyroid), and infusion-related reactions from the IV treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will continue using birth control for at least 7 days after my last dose.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organs are functioning well.
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My kidney cancer is at an intermediate-high, high risk, or I have no signs of cancer after it spread.
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I have kidney cancer with limited spread that can be surgically removed.
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I had surgery to remove a kidney or cancer spread within the last 12 weeks.
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I had surgery to remove my primary cancer and any isolated spread.
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I agree to use birth control during and up to 120 days after the study.
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My kidney cancer diagnosis includes clear cell characteristics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 89 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 89 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
Disease-Free Survival (DFS)
Secondary outcome measures
Kidney
Change From Baseline in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
+6 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo + PembrolizumabExperimental Treatment2 Interventions
Participants receive placebo orally QD for up to approximately 54 weeks PLUS pembrolizumab 400 mg via IV infusion once Q6W for up to 9 administrations (up to approximately 54 weeks).
Group II: Belzutifan + PembrolizumabExperimental Treatment2 Interventions
Participants receive belzutifan 120 mg orally once daily (QD) for up to approximately 54 weeks PLUS pembrolizumab 400 mg via intravenous (IV) infusion once every 6 weeks (Q6W) for up to 9 administrations (up to approximately 54 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
2018
Completed Phase 1
~40
Placebo
1995
Completed Phase 3
~2670
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,868 Previous Clinical Trials
5,050,243 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,770 Previous Clinical Trials
8,060,293 Total Patients Enrolled

Media Library

Belzutifan (HIF-2 Alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05239728 — Phase 3
Renal Cell Carcinoma Research Study Groups: Placebo + Pembrolizumab, Belzutifan + Pembrolizumab
Renal Cell Carcinoma Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT05239728 — Phase 3
Belzutifan (HIF-2 Alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05239728 — Phase 3

Frequently Asked Questions

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

How many people suffering from this disease will be given the chance to try this new treatment?

"Yes, according to the latest information available on clinicaltrials.gov, this study is still recruiting patients. The trial was first posted on March 15th, 2022 and last updated November 11th, 2022. So far, 31 different centres have enrolled 1600 participants in total."

Answered by AI

Has Pembrolizumab received clearance from the FDA?

"Pembrolizumab has received a score of 3 for safety by our team at Power. Phase 3 trials have some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Are there any vacancies in this trial for new participants?

"That is correct. The information available on clinicaltrials.gov does show that the trial is still recruiting patients. It was initially posted on March 15th, 2022 and was last updated November 11th, 2022. Currently, they are looking for 1600 people to participate at 31 different sites."

Answered by AI

Are there any hospitals or clinics in North America conducting this research?

"31 locations are currently running this clinical trial, some notable ones being The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C in Columbus, Dana-Farber Cancer Institute-GU ( Site 3505) in Boston, and Sanford Cancer Center ( Site 3551) in Sioux Falls."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
How old are they?
18 - 65
What site did they apply to?
Englewood Hospital and Medical Center ( Site 3557)
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 35
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
~982 spots leftby Oct 2026