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New pill shows promise for rare kidney cancer in VHL patients

NCT ID NCT03401788

Disease control Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing a daily pill called belzutifan in 50 people with VHL disease who have kidney cancer. The goal is to see if the drug can shrink tumors. Researchers are also monitoring how long any tumor shrinkage lasts and checking for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Belzutifan (a pill taken once daily)
What this could lead to
If successful, belzutifan could become a new treatment option to shrink kidney tumors in people with VHL disease, potentially reducing the need for surgery.
What could go wrong
This is a small, early-phase trial with only 50 participants, so results may not apply to everyone. The drug may not work for all patients or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2018

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration * 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 Exclusion Criteria: * Has received prior treatment with belzutifan or another HIF-2α inhibitor * Has had any systemic anti-cancer therapy (includes anti-vascular endothelial growth factor \[VEGF\] therapy or any systemic investigational anti-cancer agent) * Has an immediate need for surgical intervention for tumor treatment * Has evidence of metastatic disease on screening imaging

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Conditions

The condition(s) this trial relates to.

hereditary clear cell renal cell carcinoma renal cell carcinoma von Hippel-Lindau disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

VHL - von Hippel-Lindau syndrome VHL gene inactivation VHL gene mutation VHL syndrome VHL-associated clear cell renal cell carcinoma VHL-associated renal cell carcinoma

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Cambridge University Hospital

    Cambridge, United Kingdom

  • Hospital Georges Pompidou

    Paris, France

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232, United States

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