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New drug combo aims to control advanced kidney cancer

NCT ID NCT05468697

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 4 times

Summary

This study tests a new drug combination (belzutifan plus palbociclib) against belzutifan alone in people with advanced clear-cell kidney cancer that has worsened after at least two prior treatments. The main goals are to check safety and find the best dose of palbociclib when used with belzutifan. About 60 adults will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

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

Started

Aug 2022

Expected to finish

Oct 2026

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 histologically confirmed diagnosis of unresectable Stage IV (per American Joint Committee on Cancer \[AJCC\], 8th Edition) RCC with clear-cell component * Has had disease progression on or after having received at least 2 systemic treatments for unresectable Stage IV RCC with prior anti-programmed cell death 1 ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination * Has measurable disease per RECIST 1.1 as assessed by the investigator and verified by blinded independent central review (BICR) * Has recovered from all AEs due to previous therapies Exclusion Criteria: * Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known central nervous system (CNS) metastases and/or carcinomatous meningitis * Has clinically significant cardiac disease * Has moderate to severe hepatic impairment * Has a known history of human immunodeficiency virus (HIV) infection * Has a history of hepatitis B (HBV) or known active hepatitis C (HCV) infection * Has received prior treatment of belzutifan or palbociclib * Has received prior radiotherapy ≤2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids * Has had major surgery ≤3 weeks prior to first dose of study intervention * Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin \[EPO\]) ≤28 days prior to the first dose of study intervention

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma kidney cancer renal cell carcinoma

As listed by the trial registrant

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

Renal cell carcinoma

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001)

    Boston, Massachusetts, 02215, United States

  • Emek Medical Center-oncology ( Site 3003)

    Afula, 1834111, Israel

  • Frankston Hospital-Oncology and Haematology ( Site 2005)

    Frankston, Victoria, 3199, Australia

  • Georgetown University Medical Center ( Site 1002)

    Washington D.C., District of Columbia, 20007, United States

  • Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004)

    Salt Lake City, Utah, 84112, United States

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 2001)

    Macquarie University, New South Wales, 2109, Australia

  • One Clinical Research ( Site 2008)

    Nedlands, Western Australia, 6009, Australia

  • Rabin Medical Center-Oncology ( Site 3004)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology ( Site 3000)

    Haifa, 3109601, Israel

  • Shaare Zedek Medical Center-Oncology ( Site 3002)

    Jerusalem, 9103102, Israel

  • Sourasky Medical Center ( Site 3005)

    Tel Aviv, 6423906, Israel

  • University of Chicago Medical Center ( Site 1007)

    Chicago, Illinois, 60637, United States

  • Westmead Hospital ( Site 2006)

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.