Kidney Cancer Clinical Trial
Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)
This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.
Must have a histologically-confirmed diagnosis of non-clear cell RCC.
Has locally advanced/metastatic disease (ie, Stage IV per the American Joint Committee on Cancer).
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.
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.
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.
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.
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.
Has Karnofsky Performance Status (KPS) ≥70% as assessed within 10 days prior to the start of study intervention.
Has adequately controlled blood pressure with or without antihypertensive medications
Have adequate organ function.
Has collecting duct histology.
A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study intervention.
Has a left ventricular ejection fraction below the institutional (or local laboratory) normal range.
Has radiographic encasement or invasion of a major blood vessel, or of intratumoral cavitation.
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
Has had major surgery within 3 weeks prior to first dose of study intervention.
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).
Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to allocation.
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.
Has received a live or attenuated vaccine within 30 days before the first dose of study intervention.
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.
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.
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.
Has known active CNS metastases and/or carcinomatous meningitis.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, lenvatinib and/or any of their excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus.
Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
Has had an allogenic tissue/solid organ transplant.
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There are 56 Locations for this study
Washington District of Columbia, 20007, United States
Billings Montana, 59102, United States
Las Vegas Nevada, 89169, United States
New York New York, 10065, United States
Philadelphia Pennsylvania, 19111, United States
Nashville Tennessee, 37232, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53226, United States
Macquarie Park New South Wales, 2109, Australia
Waratah New South Wales, 2298, Australia
Brisbane Queensland, 4029, Australia
Kurralta Park South Australia, 5037, Australia
Clayton Victoria, 3168, Australia
Murdoch Western Australia, 6150, Australia
Vancouver British Columbia, V5Z 4, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Québec Quebec, G1R 3, Canada
Strasbourg Alsace, 67200, France
Caen Calvados, 14076, France
Montpellier Languedoc-Roussillon, 34070, France
Pierre-Bénite Rhone, 69310, France
Villejuif Val-de-Marne, 94800, France
Miskolc Borsod-Abauj-Zemplen, 3526, Hungary
Szolnok Jasz-Nagykun-Szolnok, 5000, Hungary
Budapest Pest, 1122, Hungary
Debrecen , 4032, Hungary
Dublin , D24 N, Ireland
Roma Lazio, 00168, Italy
Milan Lombardia, 20133, Italy
Verona Veneto, 37134, Italy
Terni , 05100, Italy
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Warszawa Mazowieckie, 01-74, Poland
Warszawa Mazowieckie, 02-78, Poland
Poznań Wielkopolskie, 60-56, Poland
Moscow Moskva, 11748, Russian Federation
Nizhniy Novgorod Nizhegorodskaya Oblast, 60308, Russian Federation
Nizhny Novgorod Nizhegorodskaya Oblast, 60307, Russian Federation
Sankt-Peterburg , 18866, Russian Federation
Madrid Madrid, Comunidad De, 28034, Spain
Valencia Valenciana, Comunitat, 46009, Spain
Barcelona , 08035, Spain
Istanbul- Fatih Istanbul, 34098, Turkey
Bornova Izmir, 35100, Turkey
Ankara , 06100, Turkey
Ankara , 06230, Turkey
Istanbul , 34722, Turkey
Cherkassy Cherkaska Oblast, 18009, Ukraine
Chernihiv Chernihivska Oblast, 14029, Ukraine
Dnipro Dnipropetrovska Oblast, 49005, Ukraine
Kharkiv Kharkivska Oblast, 61070, Ukraine
Cambridge England, CB2 0, United Kingdom
Manchester , M20 4, United Kingdom
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