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New hope for advanced kidney cancer: experimental combo therapies under study

NCT ID NCT04626518

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This study is testing experimental combinations of drugs for people with advanced kidney cancer (clear cell type) that has gotten worse after initial treatment. The goal is to see if these combinations are safe and can shrink tumors. About 370 participants will be enrolled in this early-phase trial.

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 370 people

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

Started

Dec 2020

Expected to finish

Aug 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 locally advanced/metastatic clear cell renal cell carcinoma (ccRCC) * Has experienced disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with a programmed cell death ligand 1 (PD-(L)1) checkpoint inhibitor (in sequence or in combination with a vascular endothelial growth factor. - tyrosine kinase inhibitor \[VEGF-TKI\]) where PD-(L)1 checkpoint inhibitor treatment progression is defined by meeting ALL of the following criteria: (a) has received ≥2 doses of an anti-PD-(L)1 monoclonal antibody (mAb) (b) has shown radiographic disease progression during or after an anti-PD-(L)1 mAb as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by investigator (c) disease progression has been documented within 12 weeks from the last dose of an anti-PD-(L)1 mAb * Has experienced disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with a VEGF-TKI (in sequence or in combination with a PD-\[L\]1 checkpoint inhibitor) where VEGF-TKI treatment progression is defined by meeting the following criterion: has shown radiographic disease progression during or after a treatment with a VEGF-TKI as defined by RECIST 1.1 by investigator. * Is able to swallow oral medication * Has adequate organ function * Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks before randomization/allocation * Has resolution of toxic effects of prior therapy to ≤Grade 1 * Has adequately controlled blood pressure (BP ≤150/90 mm Hg) with no change in hypertensive medications within 1 week before randomization/allocation * Male participants are abstinent from heterosexual intercourse or agree to use contraception during treatment with and for at least 7 days after the last dose of lenvatinib and /or belzutifan; 7 days after lenvatinib and/or belzutifan is stopped, if the participant is only receiving pembrolizumab, pembrolizumab/quavonlimab, favezelimab/pembrolizumab, MK-4830 or a combination of the aforementioned drugs, no contraception is needed * Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of pembrolizumab, pembrolizumab/quavonlimab, favezelimab/pembrolizumab, MK-4830 or 30 days after the last dose of lenvatinib or belzutifan, whichever occurs last and must abstain from breastfeeding during the study intervention period and for at least 120 days after study intervention Exclusion Criteria: * Has urine protein ≥1 g/24 hours and has any of the following: (a) a pulse oximeter reading \<92% at rest, or (b) requires intermittent supplemental oxygen, or (c) requires chronic supplemental oxygen (d) active hemoptysis within 3 weeks prior to the first dose of study intervention * Has clinically significant cardiovascular disease within 12 months from the first dose of study intervention administration * Has had major surgery within 3 weeks before first dose of study interventions * Has a history of lung disease * Has a history of inflammatory bowel disease * Has preexisting gastrointestinal (GI) or non-GI fistula * Has malabsorption due to prior GI surgery or disease * Has previously received treatment with a combination of pembrolizumab plus lenvatinib * Has received prior treatment with belzutifan * Has received prior radiotherapy within 2 weeks of start of study intervention * Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention; killed vaccines are allowed * Has received more than 4 previous systemic anticancer treatment regimens * Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Has 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 an active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection * Has a known history of Hepatitis B * Has had an allogenic tissue/solid organ transplant

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 nonpapillary renal cell carcinoma renal cell adenocarcinoma renal cell carcinoma

As listed by the trial registrant

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

Carcinoma, renal cell

Contacts and locations

Locations

  • Asan Medical Center ( Site 3800)

    Songpagu, Seoul, 05505, South Korea

  • Auckland City Hospital ( Site 3700)

    Auckland, 1023, New Zealand

  • Austin Health ( Site 3600)

    Melbourne, Victoria, 3084, Australia

  • Barts Health NHS Trust ( Site 3401)

    London, London, City of, EC1A 7BE, United Kingdom

  • Blacktown Hospital ( Site 3601)

    Blacktown, New South Wales, 2148, Australia

  • Bradfordhill-Clinical Area ( Site 4101)

    Santiago, Region M. de Santiago, 8420383, Chile

  • CIDO SpA-Oncology ( Site 4106)

    Temuco, Araucania, 4810148, Chile

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 4201)

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

  • Duke Cancer Institute ( Site 3015)

    Durham, North Carolina, 27710, United States

  • Erasmus Medisch Centrum ( Site 4401)

    Rotterdam, South Holland, 3015 GD, Netherlands

  • FALP-UIDO ( Site 4100)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Gustave Roussy ( Site 3202)

    Villejuif, Île-de-France Region, 94800, France

  • Hadassah Medical Center-Oncology ( Site 3504)

    Jerusalem, 9112001, Israel

  • Henry Ford Health System ( Site 3014)

    Detroit, Michigan, 48202, United States

  • Hospital Universitari Vall d Hebron ( Site 3300)

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario Ramon y Cajal ( Site 3301)

    Madrid, 28034, Spain

  • Institut Claudius Regaud ( Site 3200)

    Toulouse, Haute-Garonne, 31059, France

  • Institut De Cancerologie De Lorraine ( Site 3204)

    Vandœuvre-lès-Nancy, Ain, 54519, France

  • Institut de cancérologie Strasbourg Europe (ICANS) ( Site 3203)

    Strasbourg, Alsace, 67200, France

  • James Lind Centro de Investigacion del Cancer ( Site 4108)

    Temuco, Araucania, 4800827, Chile

  • Jewish General Hospital ( Site 3100)

    Montreal, Quebec, H3T 1E2, Canada

  • Laura and Isaac Perlmutter Cancer Center ( Site 3016)

    New York, New York, 10016, United States

  • Leicester Royal Infirmary ( Site 3408)

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Memorial Sloan Kettering Cancer Center ( Site 3002)

    New York, New York, 10065, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 4200)

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 4402)

    Amsterdam, North Holland, 1066 CX, Netherlands

  • ONCOCENTRO APYS-ACEREY ( Site 4103)

    Viña del Mar, Valparaiso, 2520598, Chile

  • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 4301)

    Budapest, Pest County, 1122, Hungary

  • Princess Margaret Cancer Centre ( Site 3101)

    Toronto, Ontario, M5G 1Z5, Canada

  • Rabin Medical Center ( Site 3502)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology Division ( Site 3500)

    Haifa, 3109601, Israel

  • Royal Brisbane and Women's Hospital ( Site 3603)

    Herston, Queensland, 4029, Australia

  • Royal Preston Hospital ( Site 3406)

    Preston, Lancashire, PR2 9HT, United Kingdom

  • Samsung Medical Center ( Site 3801)

    Seoul, 06351, South Korea

  • Severance Hospital ( Site 3802)

    Seoul, 03722, South Korea

  • Sheba Medical Center - Oncology Division ( Site 3501)

    Ramat Gan, 52621, Israel

  • Sourasky Medical Center ( Site 3503)

    Tel Aviv, 6423906, Israel

  • Southampton General Hospital ( Site 3403)

    Southampton, England, SO16 6YD, United Kingdom

  • St George Hospital ( Site 3602)

    Kogarah, New South Wales, 2217, Australia

  • The Beatson West of Scotland Cancer Centre ( Site 3405)

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • The Christie NHS Foundation Trust ( Site 3400)

    Manchester, M20 4BX, United Kingdom

  • UPMC Cancer Center/Hillman Cancer Center ( Site 3017)

    Pittsburgh, Pennsylvania, 15232, United States

  • UTSW Medical Center ( Site 3003)

    Dallas, Texas, 75390, United States

  • University of California at San Francisco ( Site 3008)

    San Francisco, California, 94158, United States

  • University of Chicago ( Site 3013)

    Chicago, Illinois, 60637, United States

  • University of Iowa ( Site 3012)

    Iowa City, Iowa, 52242, United States

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 4202)

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Vanderbilt University Medical Center ( Site 3004)

    Nashville, Tennessee, 37232, United States

  • Velindre Cancer Centre Hospital ( Site 3407)

    Cardiff, Wales, CF14 2TL, United Kingdom

  • Western General Hospital ( Site 3402)

    Edinburgh, Midlothian, EH4 2XU, United Kingdom

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 3011)

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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