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New hope for kidney cancer: drug cocktails aim to shrink tumors

NCT ID NCT04626479

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 clinical trial is testing several new combinations of drugs for people with advanced kidney cancer that has spread. The study includes about 400 participants who have not had any prior treatment for their advanced disease. The goal is to see if these combinations are safe and effective at shrinking tumors or slowing the cancer's growth.

What this could mean

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

Active substance
Pembrolizumab, favezelimab/pembrolizumab, belzutifan, lenvatinib, pembrolizumab/quavonlimab, vibostolimab
What this could lead to
If successful, this could lead to better treatment options for people with advanced kidney cancer, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial (1b/2) with a small number of participants, so results may not apply to everyone. The drug combinations may cause serious side effects, and there is no guarantee they will work better than current treatments.

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 400 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 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.

Inclusion Criteria: * Has a histologically confirmed diagnosis of locally advanced/metastatic ccRCC * Has received no prior systemic therapy for advanced RCC; prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed ≥12 months before randomization/allocation. * 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 the most recent 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 or a combination of the aforementioned drugs, no contraception is needed * Female participants must not be pregnant and not be 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 for 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 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 drug; 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 1800)

    Songpagu, Seoul, 05505, South Korea

  • Auckland City Hospital ( Site 1700)

    Auckland, 1023, New Zealand

  • Austin Health ( Site 1600)

    Heidelberg, Victoria, 3084, Australia

  • Barts Health NHS Trust ( Site 1401)

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

  • Blacktown Hospital ( Site 1601)

    Blacktown, New South Wales, 2148, Australia

  • Bradfordhill-Clinical Area ( Site 2101)

    Santiago, Region M. de Santiago, 8420383, Chile

  • C.H.U. de Strasbourg Hopital de Hautepierre ( Site 1203)

    Strasbourg, Bas-Rhin, 67098, France

  • CIDO SpA-Oncology ( Site 2106)

    Temuco, Araucania, 4810148, Chile

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2201)

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

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1900)

    Bogotá, Bogota D.C., 111321, Colombia

  • Duke Cancer Institute ( Site 1015)

    Durham, North Carolina, 27710, United States

  • Erasmus Medisch Centrum ( Site 2401)

    Rotterdam, South Holland, 3015 GD, Netherlands

  • FALP-UIDO ( Site 2100)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fundación Valle del Lili ( Site 1901)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gustave Roussy ( Site 1202)

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

  • Hadassah Medical Center-Oncology ( Site 1504)

    Jerusalem, 9112001, Israel

  • Henry Ford Health System ( Site 1014)

    Detroit, Michigan, 48202, United States

  • Hospital Universitari Vall d Hebron ( Site 1300)

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario Ramon y Cajal ( Site 1301)

    Madrid, 28034, Spain

  • Institut Claudius Regaud ( Site 1200)

    Toulouse, Haute-Garonne, 31059, France

  • Institut De Cancerologie De Lorraine ( Site 1204)

    Vandœuvre-lès-Nancy, Ain, 54519, France

  • Instituto Médico de Alta Tecnologia S.A.S ( Site 1904)

    Montería, Departamento de Córdoba, 230002, Colombia

  • James Lind Centro de Investigacion del Cancer ( Site 2108)

    Temuco, Araucania, 4800827, Chile

  • Jewish General Hospital ( Site 1100)

    Montreal, Quebec, H3T 1E2, Canada

  • Laura and Isaac Perlmutter Cancer Center ( Site 1016)

    New York, New York, 10016, United States

  • Leicester Royal Infirmary ( Site 1408)

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Memorial Sloan Kettering Cancer Center ( Site 1002)

    New York, New York, 10065, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 2200)

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402)

    Amsterdam, North Holland, 1066 CX, Netherlands

  • ONCOCENTRO APYS-ACEREY ( Site 2103)

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oncovida ( Site 2107)

    Santiago, Region M. de Santiago, 7500994, Chile

  • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 2301)

    Budapest, Pest County, 1122, Hungary

  • Princess Margaret Cancer Centre ( Site 1101)

    Toronto, Ontario, M5G 1Z5, Canada

  • Rabin Medical Center ( Site 1502)

    Petah Tikva, 4941492, Israel

  • Rambam MC ( Site 1500)

    Haifa, 3525408, Israel

  • Royal Brisbane and Women's Hospital ( Site 1603)

    Herston, Queensland, 4029, Australia

  • Royal Preston Hospital ( Site 1406)

    Preston, Lancashire, PR2 9HT, United Kingdom

  • Samsung Medical Center ( Site 1801)

    Seoul, 06351, South Korea

  • Severance Hospital ( Site 1802)

    Seoul, 03722, South Korea

  • Sheba Medical Center - Oncology Division ( Site 1501)

    Ramat Gan, 52621, Israel

  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1905)

    Valledupar, Cesar Department, 200001, Colombia

  • Sourasky Medical Center ( Site 1503)

    Tel Aviv, 6423906, Israel

  • Southampton General Hospital ( Site 1403)

    Southampton, England, SO16 6YD, United Kingdom

  • St George Hospital ( Site 1602)

    Kogarah, New South Wales, 2217, Australia

  • The Beatson West of Scotland Cancer Centre ( Site 1405)

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • The Christie NHS Foundation Trust ( Site 1400)

    Manchester, M20 4BX, United Kingdom

  • UPMC Cancer Center/Hillman Cancer Center ( Site 1017)

    Pittsburgh, Pennsylvania, 15232, United States

  • UTSW Medical Center ( Site 1003)

    Dallas, Texas, 75390, United States

  • University of California at San Francisco ( Site 1008)

    San Francisco, California, 94158, United States

  • University of Chicago ( Site 1013)

    Chicago, Illinois, 60637, United States

  • University of Iowa ( Site 1012)

    Iowa City, Iowa, 52242, United States

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2202)

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Velindre Cancer Centre Hospital ( Site 1407)

    Cardiff, Wales, CF14 2TL, United Kingdom

  • Western General Hospital ( Site 1402)

    Edinburgh, Midlothian, EH4 2XU, United Kingdom

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 1011)

    New Haven, Connecticut, 06510, United States

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