Kidney Cancer Clinical Trial

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

Summary

Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

400

Study ID:

NCT04626479

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 55 Locations for this study

See Locations Near You

University of California at San Francisco ( Site 1008)
San Francisco California, 94158, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 1011)
New Haven Connecticut, 06510, United States
University of Chicago ( Site 1013)
Chicago Illinois, 60637, United States
University of Iowa ( Site 1012)
Iowa City Iowa, 52242, United States
Henry Ford Health System ( Site 1014)
Detroit Michigan, 48202, United States
Laura and Isaac Perlmutter Cancer Center ( Site 1016)
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center ( Site 1002)
New York New York, 10065, United States
Duke Cancer Institute ( Site 1015)
Durham North Carolina, 27710, United States
UPMC Cancer Center/Hillman Cancer Center ( Site 1017)
Pittsburgh Pennsylvania, 15232, United States
UTSW Medical Center ( Site 1003)
Dallas Texas, 75390, United States
Western Sydney Local Health District ( Site 1601)
Blacktown New South Wales, 2148, Australia
St George Hospital ( Site 1602)
Kogarah New South Wales, 2217, Australia
Royal Brisbane and Women s Hospital ( Site 1603)
Herston Queensland, 4029, Australia
Austin Health ( Site 1600)
Heidelberg Victoria, 3084, Australia
Princess Margaret Cancer Centre ( Site 1101)
Toronto Ontario, M5G 1, Canada
Jewish General Hospital ( Site 1100)
Montreal Quebec, H3T 1, Canada
James Lind Centro de Investigación del Cáncer ( Site 2108)
Temuco Araucania, 48008, Chile
CIDO SpA-Oncology ( Site 2106)
Temuco Araucania, 48101, Chile
FALP-UIDO ( Site 2100)
Santiago Region M. De Santiago, 75009, Chile
Oncovida ( Site 2107)
Santiago Region M. De Santiago, 75100, Chile
Bradfordhill-Clinical Area ( Site 2101)
Santiago Region M. De Santiago, 84203, Chile
ONCOCENTRO APYS-ACEREY ( Site 2103)
Viña del Mar Valparaiso, 25205, Chile
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1905)
Valledupar Cesar, 20000, Colombia
Oncomédica S.A.S ( Site 1904)
Montería Cordoba, 23000, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1900)
Bogota Distrito Capital De Bogota, 11132, Colombia
Fundación Valle del Lili ( Site 1901)
Cali Valle Del Cauca, 76003, Colombia
Institut De Cancerologie De Lorraine ( Site 1204)
Vandoeuvre les Nancy Ain, 54519, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203)
Strasbourg Alsace, 67200, France
Institut Claudius Regaud ( Site 1200)
Toulouse Cedex 9 Haute-Garonne, 31059, France
Gustave Roussy ( Site 1202)
Villejuif Val-de-Marne, 94800, France
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 2301)
Budapest Pest, 1122, Hungary
Rambam MC ( Site 1500)
Haifa , 35254, Israel
Hadassah Medical Center-Oncology ( Site 1504)
Jerusalem , 91120, Israel
Rabin Medical Center ( Site 1502)
Petah Tiqwa , 49414, Israel
Sheba Medical Center - Oncology Division ( Site 1501)
Ramat Gan , 52621, Israel
Sourasky Medical Center ( Site 1503)
Tel Aviv , 64239, Israel
Asan Medical Center ( Site 1800)
Songpagu Seoul, 05505, Korea, Republic of
Severance Hospital ( Site 1802)
Seoul , 03722, Korea, Republic of
Samsung Medical Center ( Site 1801)
Seoul , 06351, Korea, Republic of
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402)
Amsterdam Noord-Holland, 1066C, Netherlands
Erasmus Medisch Centrum ( Site 2401)
Rotterdam Zuid-Holland, 3015 , Netherlands
Auckland City Hospital ( Site 1700)
Auckland , 1023, New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2201)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 2200
Warszawa Mazowieckie, 02-78, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2202)
Gdańsk Pomorskie, 80-95, Poland
Hospital Universitari Vall d Hebron ( Site 1300)
Barcelona Cataluna, 08035, Spain
Hospital Universitario Ramon y Cajal ( Site 1301)
Madrid , 28034, Spain
Southampton General Hospital ( Site 1403)
Southampton England, SO16 , United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1405)
Glasgow Glasgow City, G12 0, United Kingdom
Royal Preston Hospital ( Site 1406)
Preston Lancashire, PR2 9, United Kingdom
Leicester Royal Infirmary ( Site 1408)
Leicester Leicestershire, LE1 5, United Kingdom
Barts Health NHS Trust ( Site 1401)
London London, City Of, EC1A , United Kingdom
Western General Hospital ( Site 1402)
Edinburgh Midlothian, EH4 2, United Kingdom
Velindre Cancer Centre Hospital ( Site 1407)
Cardiff Wales, CF14 , United Kingdom
The Christie NHS Foundation Trust ( Site 1400)
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

400

Study ID:

NCT04626479

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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