Kidney Cancer Clinical Trial

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B)

Summary

Substudy 03B 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 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) 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 experienced disease progression on or after having received systemic. treatment for locally advanced or metastatic RCC with a 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 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

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

370

Study ID:

NCT04626518

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 51 Locations for this study

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University of California at San Francisco ( Site 3008)
San Francisco California, 94158, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 3011)
New Haven Connecticut, 06510, United States
University of Chicago ( Site 3013)
Chicago Illinois, 60637, United States
University of Iowa ( Site 3012)
Iowa City Iowa, 52242, United States
Henry Ford Health System ( Site 3014)
Detroit Michigan, 48202, United States
Laura and Isaac Perlmutter Cancer Center ( Site 3016)
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center ( Site 3002)
New York New York, 10065, United States
Duke Cancer Institute ( Site 3015)
Durham North Carolina, 27710, United States
UPMC Cancer Center/Hillman Cancer Center ( Site 3017)
Pittsburgh Pennsylvania, 15232, United States
Vanderbilt University Medical Center ( Site 3004)
Nashville Tennessee, 37232, United States
UTSW Medical Center ( Site 3003)
Dallas Texas, 75390, United States
Western Sydney Local Health District ( Site 3601)
Blacktown New South Wales, 2148, Australia
St George Hospital ( Site 3602)
Kogarah New South Wales, 2217, Australia
Royal Brisbane and Women s Hospital ( Site 3603)
Herston Queensland, 4029, Australia
Austin Health ( Site 3600)
Melbourne Victoria, 3084, Australia
Princess Margaret Cancer Centre ( Site 3101)
Toronto Ontario, M5G 1, Canada
Jewish General Hospital ( Site 3100)
Montreal Quebec, H3T 1, Canada
James Lind Centro de Investigación del Cáncer ( Site 4108)
Temuco Araucania, 48008, Chile
CIDO SpA-Oncology ( Site 4106)
Temuco Araucania, 48101, Chile
FALP-UIDO ( Site 4100)
Santiago Region M. De Santiago, 75009, Chile
Bradfordhill-Clinical Area ( Site 4101)
Santiago Region M. De Santiago, 84203, Chile
ONCOCENTRO APYS-ACEREY ( Site 4103)
Viña del Mar Valparaiso, 25205, Chile
Institut De Cancerologie De Lorraine ( Site 3204)
Vandoeuvre les Nancy Ain, 54519, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 3203)
Strasbourg Alsace, 67033, France
Institut Claudius Regaud ( Site 3200)
Toulouse Cedex 9 Haute-Garonne, 31059, France
Gustave Roussy ( Site 3202)
Villejuif Val-de-Marne, 94800, France
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 4301)
Budapest Pest, 1122, Hungary
Rambam Health Care Campus-Oncology Division ( Site 3500)
Haifa , 31096, Israel
Hadassah Medical Center-Oncology ( Site 3504)
Jerusalem , 91120, Israel
Rabin Medical Center ( Site 3502)
Petah Tiqwa , 49414, Israel
Sheba Medical Center - Oncology Division ( Site 3501)
Ramat Gan , 52621, Israel
Sourasky Medical Center ( Site 3503)
Tel Aviv , 64239, Israel
Asan Medical Center ( Site 3800)
Songpagu Seoul, 05505, Korea, Republic of
Severance Hospital ( Site 3802)
Seoul , 03722, Korea, Republic of
Samsung Medical Center ( Site 3801)
Seoul , 06351, Korea, Republic of
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 4402)
Amsterdam Noord-Holland, 1066 , Netherlands
Erasmus Medisch Centrum ( Site 4401)
Rotterdam Zuid-Holland, 3015 , Netherlands
Auckland City Hospital ( Site 3700)
Auckland , 1023, New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 4201)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 4200
Warszawa Mazowieckie, 02-78, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 4202)
Gdańsk Pomorskie, 80-95, Poland
Hospital Universitari Vall d Hebron ( Site 3300)
Barcelona Cataluna, 08035, Spain
Hospital Universitario Ramon y Cajal ( Site 3301)
Madrid , 28034, Spain
Southampton General Hospital ( Site 3403)
Southampton England, SO16 , United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 3405)
Glasgow Glasgow City, G12 0, United Kingdom
Royal Preston Hospital ( Site 3406)
Preston Lancashire, PR2 9, United Kingdom
Leicester Royal Infirmary ( Site 3408)
Leicester Leicestershire, LE1 5, United Kingdom
Barts Health NHS Trust ( Site 3401)
London London, City Of, EC1A , United Kingdom
Western General Hospital ( Site 3402)
Edinburgh Midlothian, EH42X, United Kingdom
Velindre Cancer Centre Hospital ( Site 3407)
Cardiff Wales, CF14 , United Kingdom
The Christie NHS Foundation Trust ( Site 3400)
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

370

Study ID:

NCT04626518

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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