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HIF-2alpha Inhibitor

Belzutifan for Kidney Cancer

Phase 2
Waitlist Available
Research Sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has at least 1 measurable solid RCC tumor and no RCC tumor that requires immediate surgical intervention. The diagnosis of RCC can be radiologic (histologic diagnosis not required). Participants may have VHL disease-associated tumors in other organ systems
Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights

Study Summary

This trial will test if belzutifan can shrink tumors in people with von Hippel-Lindau disease-related kidney cancer.

Who is the study for?
This trial is for individuals with von Hippel Lindau disease who have at least one measurable kidney cancer tumor but don't need immediate surgery. They shouldn't have used belzutifan or similar drugs before, had any cancer treatments like anti-VEGF therapy, require urgent tumor surgery, or have metastatic disease.Check my eligibility
What is being tested?
The study tests belzutifan as a potential treatment for kidney cancer associated with von Hippel Lindau disease. It aims to understand the effectiveness and safety of this medication in patients diagnosed with VHL-related renal cell carcinoma.See study design
What are the potential side effects?
While specific side effects of belzutifan in this trial are not listed here, common side effects may include fatigue, nausea, anemia (low red blood cell count), and hypoxia (low oxygen levels).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a measurable kidney cancer tumor that doesn't need immediate surgery.
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I have been diagnosed with von Hippel Lindau disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years 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) in VHL Disease-Associated RCC Tumors
Secondary outcome measures
Belzutifan Metabolite Plasma Concentration
Belzutifan Plasma Concentration
DOR in VHL Disease-Associated Non-RCC Tumors
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open Label BelzutifanExperimental Treatment1 Intervention
Participants receive 120 mg belzutifan orally once daily. Participants may continue to receive belzutifan in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
2018
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor
7 Previous Clinical Trials
408 Total Patients Enrolled
Peloton Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
408 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,782 Previous Clinical Trials
8,066,266 Total Patients Enrolled

Media Library

Belzutifan (HIF-2alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03401788 — Phase 2
Renal Cell Carcinoma Research Study Groups: Open Label Belzutifan
Renal Cell Carcinoma Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT03401788 — Phase 2
Belzutifan (HIF-2alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03401788 — Phase 2

Frequently Asked Questions

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

Is this research still recruiting patients to participate?

"No, this study is not actively recruiting participants. The clinical trial was originally posted on 5/2/2018 and last updated on 11/1/2022. There are 4128 other clinical trials currently accepting participants at this time."

Answered by AI

Is this the initial study of its kind to be conducted on humans?

"There are currently 16 ongoing trials for the use of Belzutifan globally. The first trial was conducted in 2016 and, although it has only been 5 years since the initial study, 1 additional trial has already been completed."

Answered by AI

Are there any known adverse effects of Belzutifan?

"Belzutifan's score is a 2. This means that while there is some evidence supporting its safety, none of the available data suggests that it is an effective medication."

Answered by AI

How many different research institutions are participating in this study?

"NIH Clinical Center in Bethesda, MD, Huntsman Cancer Institute in Salt Lake City, UT, and University of Pennsylvania Medical Center in Philadelphia are some of the places where this trial is enrolling patients. There are also 8 other sites."

Answered by AI

Do we have any prior experience with Belzutifan?

"16 different clinical trials for Belzutifan are ongoing, with 3 of those in Phase 3. The majority of these studies originate from Omaha, Nebraska, but there are 849 research sites total conducting investigations into Belzutifan."

Answered by AI

What are the common indications for Belzutifan?

"Belzutifan can be used to ameliorate the symptoms of malignant neoplasms, anemia, sickle cell, and von hippel lindau disease."

Answered by AI

How many test subjects are a part of this research?

"As of right now, this clinical trial has no open positions. However, it is important to note that the date range for this study was from May 2nd, 2018 to November 1st, 2022. If you are looking for other trials enrolling participants with carcinoma or renal cell, there are 4112 and 16 studies respectively that may have open positions."

Answered by AI
~12 spots leftby Mar 2026