A Phase 3 interventional study of Belzutifan and Nivolumab in Von Hippel-Lindau Disease and Malignant Neoplasms, sponsored by Merck Sharp & Dohme LLC. Recruiting at 57 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
Among 33 studies in von Hippel-Lindau Disease with a site in United States — 8 open to participants now, 11 under way, 1 of them phase 3. von Hippel-Lindau Disease · United States.
Among the 33 studies in von Hippel-Lindau Disease with a site in United States, this one is the 3rd largest by planned enrollment of the 23 interventional ones, is the only one that started in 2026, is the only one in phase 3, and was the 33rd registered.
55 studies on the registry are indexed under von Hippel-Lindau Disease; 23 are open to participants now.
This study's planned enrollment of 450 is above the median of 28 across 31 interventional studies indexed under von Hippel-Lindau Disease.
Browse von Hippel-Lindau Disease studies →8 of the 33 studies in von Hippel-Lindau Disease with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 20 von Hippel-Lindau Disease studies recruiting now, 16 (80%) set no upper age limit and 0 (0%) stop at 75 or younger; 9 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →33 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 1 started in 2026.
Median enrollment 15 across the 23 interventional studies, 300 across the 10 observational. Of the 22 that completed or were terminated, 9 (41%) have results posted.
6 of 33 have an industry lead sponsor. The 10 most frequent:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Merck Sharp & Dohme LLC has 3 studies filed under von Hippel-Lindau Disease — fewer than ten, so there is no comparison to draw.
3 of the studies in von Hippel-Lindau Disease with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05955014M.D. Anderson Cancer CenterData Collection Protocol for Patients With Von Hippel Lindau Disease | 2026-12-31 |
| NCT03401788Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004) | 2027-04-29 |
| NCT05737602Massachusetts General HospitalPromoting Stress Management and Resilience Among Individuals With Von Hippel- Lindau Disease | 2027-05-01 |
Among the 33 studies in von Hippel-Lindau Disease with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors:
Researchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Participants on active treatment assigned to belzutifan monotherapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Drug: Belzutifan
Participants on active treatment assigned to a belzutifan combination therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Drug: Belzutifan · Drug: Nivolumab · Drug: Lenvatinib · Drug: Cabozantinib
Participants on active treatment assigned to a non-belzutifan therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Drug: Lenvatinib · Drug: Cabozantinib
Belzutifan is administered orally at 120 mg once daily (qd) OR 200 mg qd until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Also known as: MK-6482, PT2977, WELIREG
Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Cohort A and Cohort B: Overall Survival (OS)
Overall survival is defined as the time from randomization or the first dose of any study intervention in the parent study to death due to any cause.
Time frame: Up to approximately 7 years
Number of Participants Who Experience One or More Adverse Events (AE)
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time frame: Up to approximately 2 years
Number of Participants Who Discontinued Study Intervention Due to an AE
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time frame: Up to approximately 2 years
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Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Started Mar 2026 (actual). Primary completion is estimated for Apr 2034, 96 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Belzutifan · Cabozantinib