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HIF-2alpha Inhibitor

Triple Drug Combo for Solid Cancers

Phase 2
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 60 months
Awards & highlights

Study Summary

This trial will investigate the safety and effectiveness of a combination of drugs in treating multiple solid tumors.

Who is the study for?
This trial is for adults with certain advanced solid tumors, including liver, colorectal, pancreatic, biliary tract, endometrial, and esophageal cancers. Participants must have measurable disease progression and agree to contraceptive measures. Exclusions include active second malignancies within 3 years, severe lung or liver conditions, HIV/Hepatitis infections (with some exceptions), and prior treatments with specific drugs.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining belzutifan with pembrolizumab and lenvatinib in treating various solid tumors. It aims to see how well patients respond to this combination therapy without formal hypothesis testing.See study design
What are the potential side effects?
Potential side effects may include high blood pressure that needs medication control; fatigue; digestive issues like nausea or diarrhea; skin reactions; immune-related complications affecting organs such as lungs or intestines; increased risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 60 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
Arm 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Arm 1: Number of Participants Who Experience at Least One Adverse Event (AE)
Arm 1: Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)
+1 more
Secondary outcome measures
Arm 2: Number of Participants Who Discontinued Study Treatment Due to an AE
Arm 2: Number of Participants Who Experienced an Adverse Event (AE)
DCR Per mRECIST 1.1 for HCC as Assessed by BICR
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Participants with IO resistant ESCC will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered via intravenous (IV) infusion once every 6 weeks (Q6W) for a maximum of 18 doses (approximately 2 years). Lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.
Group II: Arm 1: Pembrolizumab + Belzutifan + LenvatinibExperimental Treatment3 Interventions
Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg (For HCC: 8 mg [body weight <60kg] or 12 mg [body weight ≥ 60 kg]). Pembrolizumab will be administered via intravenous (IV) infusion once every 6 weeks (Q6W) for a maximum of 18 doses (approximately 2 years). Belzutifan and lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2005
Completed Phase 4
~2690
Pembrolizumab
2017
Completed Phase 2
~2010
Belzutifan
2018
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,405 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,059,941 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,010 Total Patients Enrolled

Media Library

Belzutifan (HIF-2alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04976634 — Phase 2
Colorectal Cancer Research Study Groups: Arm 2: Pembrolizumab + Lenvatinib, Arm 1: Pembrolizumab + Belzutifan + Lenvatinib
Colorectal Cancer Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT04976634 — Phase 2
Belzutifan (HIF-2alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04976634 — Phase 2

Frequently Asked Questions

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

What is the estimated number of participants in this research undertaking?

"This research project will be conducted by Merck Sharp & Dohme LLC and necessitates 730 participants that meet the specified criteria. Two of their medical centres, Memorial Sloan Kettering Cancer Center (Site 5050) in New york, NY and City of Hope Comprehensive Cancer Center ( Site 5002) in Duarte, CA are expected to have a prominent role throughout the trial."

Answered by AI

In what localities can participants access this research endeavor?

"The trial is available at 14 sites, including Memorial Sloan Kettering Cancer Center (Site 5050) in New york City, City of Hope Comprehensive Cancer Center (Site 5002) in Duarte CA, and Cedars-Sinai Medical Center ( Site 5045 )in Los Angeles. Additionally there are other locations offering the drug treatment."

Answered by AI

What health conditions is Belzutifan most commonly employed to address?

"Belzutifan has been shown to be an effective treatment for patients with unresectable melanoma, microsatellite instability high conditions as well as those at risk of relapse."

Answered by AI

Are there any openings still available for participation in this experiment?

"Affirmative. Clinicaltrials.gov data confirms that this medical trial, which was launched on August 18th 2021 is still actively recruiting patients from 14 different sites with a goal of 730 participants in total."

Answered by AI

What safety considerations should be taken into account when utilizing Belzutifan?

"Despite being at Phase 2, our team believes that Belzutifan is reasonably safe and has thus assigned a score of 2. As the trial is still ongoing, clinical efficacy data remains unavailable."

Answered by AI

Could you elaborate on the other empirical tests conducted with Belzutifan?

"Belzutifan was initially studied in 2010 by City of Hope. This has since been followed up with 303 completed studies, and there are currently 1042 ongoing clinical trials primarily operating from New york City."

Answered by AI

What is the objective of this clinical research effort?

"Merck Sharp & Dohme LLC, the founder of this trial, reports that its primary objective is to measure adverse events in participants over a period of 21 days. Additionally, other secondary outcomes include progression-free survival per RECIST 1.1 and best overall response (CR/PR/SD) after 6 weeks measured by BICR as well as participant Adverse Events when treated with pembrolizumab plus lenvatinib."

Answered by AI
~328 spots leftby Aug 2026