← Back to Search

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

Summary

This trial is testing a new treatment combining three drugs to help patients with difficult-to-treat cancers. The treatment aims to stop cancer growth, help the immune system fight the cancer, and cut off the blood supply to 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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
2017
Completed Phase 4
~2040
Pembrolizumab
2017
Completed Phase 2
~2070
Belzutifan
2018
Completed Phase 1
~50

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Belzutifan, a HIF-2α inhibitor, targets hypoxia-inducible factors to hinder tumor growth under low oxygen conditions. Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to attack cancer cells by blocking the PD-1 pathway. Lenvatinib, a multi-kinase inhibitor, targets multiple receptor tyrosine kinases involved in tumor angiogenesis and growth. These mechanisms are vital for colorectal cancer patients as they offer targeted approaches to disrupt cancer progression and improve treatment outcomes.
Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.New and emerging combination therapies for esophageal cancer.The long and winding road to useful predictive factors for anti-EGFR therapy in metastatic colorectal carcinoma: the KRAS/BRAF pathway.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,849 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,253 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,050 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
~327 spots leftby Mar 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top