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New drug combo shows promise for rare kidney cancer

NCT ID NCT04704219

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a combination of two drugs, pembrolizumab and lenvatinib, in 160 people with a rare type of advanced kidney cancer (non-clear cell renal cell carcinoma) that had not been treated before. The goal was to see if the drugs could shrink tumors. The study found that some patients experienced tumor shrinkage, but ongoing treatment is needed to control the disease.

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

160 people

The number who actually took part.

Started

Feb 2021

Finished

Oct 2025

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: 1. Must have a histologically confirmed diagnosis of nccRCC. 2. Has locally advanced/metastatic disease (ie, Stage IV per the American Joint Committee on Cancer). 3. Has received no prior systemic therapy for advanced nccRCC. Note: Prior neoadjuvant/adjuvant therapy for nccRCC is acceptable if completed \>12 months prior to allocation. 4. Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of study medication, or refrain from heterosexual intercourse during this period. 5. Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last. 6. Has measurable disease per RECIST 1.1 as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 7. Has submitted an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. 8. Has Karnofsky Performance Status (KPS) ≥70% as assessed within 10 days prior to the start of study intervention. 9. Has adequately controlled blood pressure with or without antihypertensive medications 10. Have adequate organ function. Exclusion Criteria: 1. Has collecting duct histology. 2. A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study intervention. 3. Has a left ventricular ejection fraction below the institutional (or local laboratory) normal range. 4. Has radiographic encasement or invasion of a major blood vessel, or of intratumoral cavitation. 5. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention. 6. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib. 7. Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug. 8. Has had major surgery within 3 weeks prior to first dose of study intervention. 9. Has received prior therapy with an anti-programmed cell-death 1 (PD-1), anti-programmed cell-death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). 10. Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to allocation. 11. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease. 12. Has received a live or attenuated vaccine within 30 days before the first dose of study intervention. 13. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. 14. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. 15. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 16. Has known active CNS metastases and/or carcinomatous meningitis. 17. Has severe hypersensitivity (≥Grade 3) to pembrolizumab, lenvatinib and/or any of their excipients. 18. Has an active autoimmune disease that has required systemic treatment in past 2 years 19. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 20. Has an active infection requiring systemic therapy. 21. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority. 22. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus. 23. Has a known history of active tuberculosis (TB; Bacillus tuberculosis). 24. 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 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

  • Ankara University Hospital Cebeci ( Site 1105)

    Ankara, 06100, Turkey (Türkiye)

  • Asan Medical Center-Department of Oncology ( Site 1300)

    Seoul, 05505, South Korea

  • Ashford Cancer Centre Research ( Site 0404)

    Kurralta Park, South Australia, 5037, Australia

  • Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 0900)

    Terni, 05100, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0902)

    Verona, Veneto, 37134, Italy

  • BC Cancer Vancouver-Clinical Trials Unit ( Site 1500)

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C

    Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

  • CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 1502)

    Québec, Quebec, G1R 3S1, Canada

  • CNPE "Regional Center of Oncology"-oncourology department ( Site 0502)

    Kharkiv, Kharkiv Oblast, 61070, Ukraine

  • Calvary Mater Newcastle ( Site 0403)

    Waratah, New South Wales, 2298, Australia

  • Cambridge University Hospital ( Site 1200)

    Cambridge, England, CB2 0QQ, United Kingdom

  • Centre François Baclesse ( Site 1000)

    Caen, Calvados, 14076, France

  • Centre de Cancérologie du Grand Montpellier ( Site 1005)

    Montpellier, Languedoc-Roussillon, 34070, France

  • Cherkasy Regional Oncology Dispensary ( Site 0504)

    Cherkassy, Cherkasy Oblast, 18009, Ukraine

  • Chernihiv Medical Center of Modern Oncology ( Site 0509)

    Chernihiv, Chernihiv Oblast, 14029, Ukraine

  • Comprehensive Cancer Centers of Nevada ( Site 0010)

    Las Vegas, Nevada, 89169, United States

  • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0300)

    Debrecen, 4032, Hungary

  • Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 0508)

    Dnipro, Dnipropetrovsk Oblast, 49005, Ukraine

  • Ege University Medicine of Faculty ( Site 1102)

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Fiona Stanley Hospital ( Site 0402)

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0903)

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 0901)

    Rome, Lazio, 00168, Italy

  • Fox Chase Cancer Center ( Site 0011)

    Philadelphia, Pennsylvania, 19111, United States

  • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0202)

    Valencia, Valenciana, Comunitat, 46009, Spain

  • Georgetown University Medical Center ( Site 0001)

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

  • Gustave Roussy ( Site 1002)

    Villejuif, Val-de-Marne, 94800, France

  • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1103)

    Istanbul, 34722, Turkey (Türkiye)

  • Hacettepe Universitesi-oncology hospital ( Site 1101)

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0201)

    Barcelona, 08035, Spain

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0200)

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1007)

    Strasbourg, Alsace, 67200, France

  • Istanbul Universitesi Cerrahpasa ( Site 1104)

    Istanbul- Fatih, Istanbul, 34098, Turkey (Türkiye)

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0303)

    Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

  • Luxmed Onkologia sp. z o. o. ( Site 0802)

    Warsaw, Masovian Voivodeship, 01-748, Poland

  • MEDICAL COLLEGE OF WISCONSIN ( Site 0006)

    Milwaukee, Wisconsin, 53226, United States

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 0405)

    Macquarie Park, New South Wales, 2109, Australia

  • Memorial Sloan Kettering Cancer Center ( Site 0015)

    New York, New York, 10065, United States

  • Monash Health ( Site 0400)

    Clayton, Victoria, 3168, Australia

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0605)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia

  • Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 0304)

    Budapest, Pest County, 1122, Hungary

  • Princess Margaret Cancer Centre ( Site 1504)

    Toronto, Ontario, M5G 2M9, Canada

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

    Brisbane, Queensland, 4029, Australia

  • Russian Scientific Center of Radiology-Russian Scientific Center of Radiology ( Site 0602)

    Moscow, Moscow, 117485, Russia

  • SHBI Leningrad Regional Clinical Oncology Dispensary-Clinical Trials Department ( Site 0607)

    Saint Petersburg, 188663, Russia

  • Samsung Medical Center ( Site 1301)

    Seoul, 06351, South Korea

  • Seattle Cancer Care Alliance ( Site 0014)

    Seattle, Washington, 98109, United States

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1302)

    Seoul, 03722, South Korea

  • St. Vincent Frontier Cancer Center ( Site 0004)

    Billings, Montana, 59102, United States

  • Sunnybrook Health Sciences Centre ( Site 1501)

    Toronto, Ontario, M4N 3M5, Canada

  • Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-chemotherapy department ( Site 0800)

    Poznan, Greater Poland Voivodeship, 60-569, Poland

  • Tallaght University Hospital ( Site 1600)

    Dublin, D24 NR0A, Ireland

  • The Christie ( Site 1205)

    Manchester, M20 4BX, United Kingdom

  • Vanderbilt University Medical Center ( Site 0008)

    Nashville, Tennessee, 37232, United States

  • Volga District Medical Center-Urology Department ( Site 0604)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603074, Russia

  • centre hospitalier lyon sud ( Site 1003)

    Pierre-Bénite, Rhone, 69310, France

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