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HIF-2alpha Inhibitor

Belzutifan + Cabozantinib for Kidney Cancer

Phase 2

Waitlist Available

Research Sponsored by Peloton Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has locally advanced or metastatic RCC with predominantly clear cell subtype

Has adequate organ function including absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL, and platelet count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years

Awards & highlights

Study Summary

This trial will study the effects of two drugs, belzutifan and cabozantinib, when taken together by people with advanced kidney cancer. The drugs will be taken orally once daily.

Who is the study for?

This trial is for adults with advanced clear cell renal cell carcinoma (ccRCC). Participants should have measurable tumors, good performance status, and proper organ function. Some can't join if they've had certain treatments for ccRCC or major surgery recently, uncontrolled hypertension, active infections needing treatment, or are in another clinical trial.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of combining two oral drugs: Belzutifan and Cabozantinib. It's an open-label Phase 2 study where all participants know which treatment they're getting and take the medications daily to treat advanced kidney cancer.See study design

What are the potential side effects?

Potential side effects from Belzutifan and Cabozantinib may include high blood pressure, fatigue, mouth sores, hand-foot syndrome (redness and pain on palms or soles), diarrhea, decreased appetite, weight loss, nausea/vomiting. Each person's experience with side effects might vary.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer is advanced or has spread and is mainly clear cell type.

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My blood tests show normal white blood cells, hemoglobin, and platelets.

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My total bilirubin level is 1.5 mg/dL or lower.

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I am fully active or can carry out light work.

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I have not had any systemic therapy for advanced kidney cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 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

Overall Response Rate (ORR)

Secondary outcome measures

Belzutifan Metabolite Plasma Concentration

Belzutifan Plasma Concentration

Cabozantinib Plasma Concentration

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Belzutifan + Cabozantinib: Treatment Naïve (Cohort 1)Experimental Treatment2 Interventions

Naïve participants will receive 120 mg belzutifan and 60 mg cabozantinib orally once daily (QD) at the same time.

Group II: Belzutifan + Cabozantinib: Prior Immunotherapy (Cohort 2)Experimental Treatment2 Interventions

Participants who have received prior immunotherapy will receive 120 mg belzutifan and 60 mg cabozantinib orally QD at the same time.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib

FDA approved

Belzutifan

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Peloton Therapeutics, Inc.Lead Sponsor

7 Previous Clinical Trials

340 Total Patients Enrolled

Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor

7 Previous Clinical Trials

340 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,366 Total Patients Enrolled

Media Library

Belzutifan (HIF-2alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03634540 — Phase 2

Renal Cell Carcinoma Research Study Groups: Belzutifan + Cabozantinib: Treatment Naïve (Cohort 1), Belzutifan + Cabozantinib: Prior Immunotherapy (Cohort 2)

Renal Cell Carcinoma Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT03634540 — Phase 2

Belzutifan (HIF-2alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03634540 — Phase 2

Frequently Asked Questions

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

What pathologies does Belzutifan help to alleviate?

"Belzutifan is an effective remedy to treat malignant neoplasms, while also providing benefit for patients at risk of acquiring renal cell carcinoma and being treated with sorafenib."

Answered by AI

How many participants are involved in this medical research?

"This trial requires 118 eligible patients to partake in the research. Prospective participants may join from either Dana Farber Cancer Center (Site 0006) in Boston, MA or Karmanos Cancer Institute (Site 0033) in Detroit, MI."

Answered by AI

Could you describe the previous experiments utilizing Belzutifan?

"Belzutifan was first trialled in 2012 at the Memorial Sloan Kettering Commack. Since then, there have been 56 completed trials and 123 that are currently recruiting patients across various medical centres located mainly in Boston, MA."

Answered by AI

How many sites are involved in the implementation of this clinical trial?

"Nine medical facilities are participating in this study, such as Dana Farber Cancer Center (Site 0006) located in Boston, Karmanos Cancer Institute (Site 0033) based in Detroit, and Sylvester Comprehensive Cancer Center ( Site 0023) situated in Miami."

Answered by AI

Does this experiment represent a pioneering approach to medicine?

"Since 2012, Belzutifan has been studied extensively. The first research was conducted under the aegis of Exelixis and included 86 participants. Subsequent Phase 2 drug approval led to over 120 active trial sites spread out across 1470 cities and 51 countries."

Answered by AI

Are there any vacant positions for participants in this experiment?

"Indeed, according to clinicaltrials.gov the recruitment for this trial is still underway. Initially posted on September 27th 2018 and most recently amended on August 5th 2022, this study requires 118 participants from 9 medical locations."

Answered by AI

Has Belzutifan been granted sanction by the FDA?

"Belzutifan's safety has been partially confirmed through the evidence gathered in Phase 2 trials, earning it a score of two. Unfortunately, no efficacy data exists at this point."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)

2018. "A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03634540.

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