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New hope for kidney cancer patients whose tumors return after immunotherapy

NCT ID NCT07049926

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 8 times

Summary

This study tests experimental drug combinations for people with advanced kidney cancer (clear cell type) that came back during or within 2 years of finishing immunotherapy. About 140 participants will receive these combinations to see if they are safe and can shrink tumors. The goal is to control the disease, not cure it, as ongoing treatment is expected.

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 140 people

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

Started

Jul 2025

Expected to finish

Oct 2031

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 to 120 years

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.

The main inclusion criteria include but are not limited to the following: * Has a histologically confirmed diagnosis of unresectable locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component * Has received no other prior systemic therapy for treatment of advanced/metastatic clear cell renal cell carcinoma (ccRCC) except for adjuvant programmed cell death ligand 1 (PD-(L)1) therapy * Has disease recurrence during adjuvant anti- PD-(L)1 therapy or ≤24 months following the last dose of adjuvant anti-PD-(L)1 therapy * Is able to swallow oral medication * Submits an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Participants receiving bone resorptive therapy (must have therapy initiated at least 2 weeks before allocation/randomization) * Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140/90 mm Hg with no change in antihypertensive medications within 1 week before allocation/randomization * Has adequate organ function The main exclusion criteria include but are not limited to the following: * Has clinically significant hematuria, hematemesis, or hemoptysis of (\>2.5 mL) of red blood, or other history of significant bleeding * Has clinically significant cardiovascular disease within 12 months from first dose of study intervention * Has deep vein thrombosis within 3 months before allocation/randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before allocation/randomization * Has history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis * Has serious wound, ulcer or bone fracture or has had major surgery within 8 weeks before first dose of study intervention * Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage in the last 4 weeks before allocation/randomization * Has gastrointestinal (GI) disorders, including those associated with a high risk of perforation or fistula formation * Has malabsorption due to prior GI surgery or GI disease * Has moderate to severe hepatic impairment * Has received colony-stimulating factors within 28 days prior to intervention allocation/randomization * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Is currently receiving strong inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study * Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention * Is currently receiving anticoagulants or platelet inhibitors that cannot be discontinued for the duration of the study * Have been previously allocated/randomized to study intervention in any sub study of protocol MK-3475-U03 * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation * Has active autoimmune disease that has required systemic treatment in the past 2 years * Has an active infection requiring systemic therapy * Has history of human immunodeficiency virus (HIV) infection * Has hepatitis B or hepatitis C virus infection

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Conditions

The condition(s) this trial relates to.

nonpapillary renal cell carcinoma renal cell carcinoma

As listed by the trial registrant

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

Renal cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    28 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center ( Site 5800)

    RECRUITING

    Seoul, 05505, South Korea

  • Bradfordhill ( Site 6101)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • C.H.U. de Strasbourg Hopital de Hautepierre ( Site 5203)

    RECRUITING

    Strasbourg, Bas-Rhin, 67098, France

  • Centre Eugene Marquis ( Site 5205)

    RECRUITING

    Rennes, Ille-et-Vilaine, 35042, France

  • Centro de Estudios Clínicos SAGA ( Site 6110)

    RECRUITING

    Santiago, Region M. de Santiago, 7500653, Chile

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 6201)

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

  • Duke Cancer Institute ( Site 5015)

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Gustave Roussy ( Site 5202)

    RECRUITING

    Villejuif, Île-de-France Region, 94805, France

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 5302)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28007, Spain

  • Hospital Universitari Vall d'Hebron ( Site 5300)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Ramon y Cajal ( Site 5301)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Institut Claudius Regaud ( Site 5200)

    RECRUITING

    Toulouse, Haute-Garonne, 31059, France

  • Institut De Cancerologie De Lorraine ( Site 5204)

    RECRUITING

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54513, France

  • Laura and Isaac Perlmutter Cancer Center ( Site 5016)

    RECRUITING

    New York, New York, 10016, United States

  • Memorial Sloan Kettering Cancer Center ( Site 5002)

    RECRUITING

    New York, New York, 10065, United States

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie ( Site 6203)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5026)

    RECRUITING

    Mineola, New York, 11501, United States

  • Rabin Medical Center ( Site 5502)

    ACTIVE_NOT_RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 5500)

    ACTIVE_NOT_RECRUITING

    Haifa, 3109601, Israel

  • Samsung Medical Center ( Site 5801)

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital ( Site 5802)

    RECRUITING

    Seoul, 03722, South Korea

  • Sheba Medical Center ( Site 5501)

    ACTIVE_NOT_RECRUITING

    Ramat Gan, 5265601, Israel

  • Sourasky Medical Center ( Site 5503)

    ACTIVE_NOT_RECRUITING

    Tel Aviv, 6423906, Israel

  • St Bartholomew's Hospital ( Site 5401)

    RECRUITING

    London, London, City of, EC1A7BE, United Kingdom

  • The Beatson West of Scotland Cancer Centre ( Site 5405)

    RECRUITING

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • The Christie NHS Foundation Trust ( Site 5400)

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • UCSF Medical Center at Mission Bay ( Site 5008)

    RECRUITING

    San Francisco, California, 94158, United States

  • UPMC Cancer Center/Hillman Cancer Center ( Site 5017)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Uniwersyteckie Centrum Kliniczne ( Site 6202)

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Vanderbilt University Medical Center ( Site 5004)

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Velindre Cancer Centre ( Site 5407)

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Western General Hospital ( Site 5402)

    RECRUITING

    Edinburgh, Edinburgh, City of, EH42XU, United Kingdom

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