- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04626479
Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Toll Free Number
- Phone Number: 1-888-577-8839
- Email: Trialsites@merck.com
Study Locations
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Western Sydney Local Health District ( Site 1601)
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Kogarah, New South Wales, Australia, 2217
- St George Hospital ( Site 1602)
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Queensland
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Herston, Queensland, Australia, 4029
- Royal Brisbane and Women s Hospital ( Site 1603)
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Austin Health ( Site 1600)
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Ontario
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Toronto, Ontario, Canada, M5G 1Z5
- Princess Margaret Cancer Centre ( Site 1101)
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital ( Site 1100)
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Araucania
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Temuco, Araucania, Chile, 4800827
- James Lind Centro de Investigación del Cáncer ( Site 2108)
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Temuco, Araucania, Chile, 4810148
- CIDO SpA-Oncology ( Site 2106)
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Region M. De Santiago
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Santiago, Region M. De Santiago, Chile, 7500921
- FALP-UIDO ( Site 2100)
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Santiago, Region M. De Santiago, Chile, 7510032
- Oncovida ( Site 2107)
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Santiago, Region M. De Santiago, Chile, 8420383
- Bradfordhill-Clinical Area ( Site 2101)
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
- ONCOCENTRO APYS-ACEREY ( Site 2103)
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Cesar
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Valledupar, Cesar, Colombia, 200001
- Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1905)
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Cordoba
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Montería, Cordoba, Colombia, 230002
- Oncomédica S.A.S ( Site 1904)
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Distrito Capital De Bogota
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Bogota, Distrito Capital De Bogota, Colombia, 111321
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1900)
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia, 760032
- Fundación Valle del Lili ( Site 1901)
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Ain
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Vandoeuvre les Nancy, Ain, France, 54519
- Institut De Cancerologie De Lorraine ( Site 1204)
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Alsace
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Strasbourg, Alsace, France, 67200
- Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203)
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Haute-Garonne
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Toulouse Cedex 9, Haute-Garonne, France, 31059
- Institut Claudius Regaud ( Site 1200)
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Val-de-Marne
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Villejuif, Val-de-Marne, France, 94800
- Gustave Roussy ( Site 1202)
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Pest
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Budapest, Pest, Hungary, 1122
- Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 2301)
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Haifa, Israel, 3525408
- Rambam MC ( Site 1500)
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Jerusalem, Israel, 9112001
- Hadassah Medical Center-Oncology ( Site 1504)
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Petah Tiqwa, Israel, 4941492
- Rabin Medical Center ( Site 1502)
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Ramat Gan, Israel, 52621
- Sheba Medical Center - Oncology Division ( Site 1501)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 1503)
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Seoul, Korea, Republic of, 03722
- Severance Hospital ( Site 1802)
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center ( Site 1801)
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Seoul
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Songpagu, Seoul, Korea, Republic of, 05505
- Asan Medical Center ( Site 1800)
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1066CX
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402)
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Zuid-Holland
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Rotterdam, Zuid-Holland, Netherlands, 3015 GD
- Erasmus Medisch Centrum ( Site 2401)
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Auckland, New Zealand, 1023
- Auckland City Hospital ( Site 1700)
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Kujawsko-pomorskie
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Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2201)
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Mazowieckie
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Warszawa, Mazowieckie, Poland, 02-781
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 2200
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Pomorskie
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Gdańsk, Pomorskie, Poland, 80-952
- Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2202)
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Madrid, Spain, 28034
- Hospital Universitario Ramon y Cajal ( Site 1301)
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Cataluna
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Barcelona, Cataluna, Spain, 08035
- Hospital Universitari Vall d Hebron ( Site 1300)
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Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust ( Site 1400)
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England
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Southampton, England, United Kingdom, SO16 6YD
- Southampton General Hospital ( Site 1403)
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Glasgow City
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Glasgow, Glasgow City, United Kingdom, G12 0YN
- The Beatson West of Scotland Cancer Centre ( Site 1405)
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Lancashire
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Preston, Lancashire, United Kingdom, PR2 9HT
- Royal Preston Hospital ( Site 1406)
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Leicestershire
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Leicester, Leicestershire, United Kingdom, LE1 5WW
- Leicester Royal Infirmary ( Site 1408)
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London, City Of
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London, London, City Of, United Kingdom, EC1A 7BE
- Barts Health NHS Trust ( Site 1401)
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Midlothian
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Edinburgh, Midlothian, United Kingdom, EH4 2XU
- Western General Hospital ( Site 1402)
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Wales
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Cardiff, Wales, United Kingdom, CF14 2TL
- Velindre Cancer Centre Hospital ( Site 1407)
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California
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San Francisco, California, United States, 94158
- University of California at San Francisco ( Site 1008)
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale-New Haven Hospital-Yale Cancer Center ( Site 1011)
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago ( Site 1013)
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa ( Site 1012)
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System ( Site 1014)
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New York
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New York, New York, United States, 10016
- Laura and Isaac Perlmutter Cancer Center ( Site 1016)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center ( Site 1002)
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Cancer Institute ( Site 1015)
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC Cancer Center/Hillman Cancer Center ( Site 1017)
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Texas
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Dallas, Texas, United States, 75390
- UTSW Medical Center ( Site 1003)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg.
Pembrolizumab/quavonlimab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 17 administrations (up to ~2 years).
Lenvatinib will be administered orally once-daily (QD) until progressive disease or discontinuation.
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Administered via oral capsule at a dose of 20 mg QD
Other Names:
Administered via IV infusion at a dose of 400 mg/25 mg Q6W
Other Names:
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Experimental: Coformulation Favezelimab/Pembrolizumab+ Lenvatinib
Participants will receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg) PLUS lenvatinib 20 mg.
Favezelimab/Pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years).
Lenvatinib will be administered orally QD until progressive disease or discontinuation.
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Administered via oral capsule at a dose of 20 mg QD
Other Names:
Administered via IV infusion at a dose of 800 mg/200 mg Q3W
Other Names:
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Experimental: Pembrolizumab + Belzutifan + Lenvatinib
Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg.
Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to ~2 years).
Both belzutifan and lenvatinib will be administered orally QD until progressive disease or discontinuation.
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Administered via oral capsule at a dose of 20 mg QD
Other Names:
Administered via IV infusion at a dose of 400 mg Q6W
Other Names:
Administered via oral tablet at a dose of 120 mg QD
Other Names:
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Experimental: Pembrolizumab + Lenvatinib
Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg.
Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to ~ 2 years).
Lenvatinib will be administered orally QD until progressive disease or discontinuation.
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Administered via oral capsule at a dose of 20 mg QD
Other Names:
Administered via IV infusion at a dose of 400 mg Q6W
Other Names:
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Experimental: Coformulation Vibostolimab/Pembrolizumab+Belzutifan
Participants will receive vibostolimab/pembrolizumab (coformulation of 200 mg vibostolimab and pembrolizumab 200 mg).
Vibostolimab/pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years).
Belzutifan will be administered orally QD until progressive disease or discontinuation.
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Administered via oral tablet at a dose of 120 mg QD
Other Names:
Administered via IV infusion at a dose of 200 mg/200 mg Q6W
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Lead-in Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs)
Time Frame: Up to ~21 days
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DLTs are defined as one or more of the following toxicities: (1) grade (gr) 4 nonhematologic toxicity (2) gr 4 hematologic toxicity lasting >7 days OR gr 4 platelet count decreased of any duration OR gr 3 platelet count decreased if associated with bleeding (3) gr 3 nonhematologic toxicity except gr 3 fatigue (lasting ≤3 days), diarrhea, nausea, vomiting or rash without standard of care (4) gr 3 or 4 nonhematologic abnormality if medical intervention is required or if it leads to hospitalization or persists for >1 week (5) gr 3 or 4 febrile neutropenia (6) gr 3 or 4 alanine aminotransferase, aspartate aminotransferase and/or bilirubin laboratory value (7) treatment related adverse event (AE) causing study intervention discontinuation during the first 21 days (8) treatment related AE causing intervention administration delay for >14 days during the first 21 days (9) gr 5 toxicity.
The number of participants who experience one or more DLTs in the safety lead-in phase will be presented.
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Up to ~21 days
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Safety Lead-in Phase: Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to ~21 days
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants who experience one or more AEs in the safety lead-in phase will be presented.
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Up to ~21 days
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Safety Lead-in Phase: Number of participants who discontinue study treatment due to an AE
Time Frame: Up to ~21 days
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants who discontinue study treatment due to an AE in the safety lead-in phase will be presented.
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Up to ~21 days
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Efficacy Phase: Number of participants who experience one or more DLTs
Time Frame: Up to ~21 days
|
DLTs are defined as one or more of the following toxicities: (1) grade (gr) 4 nonhematologic toxicity (2) gr 4 hematologic toxicity lasting >7 days OR gr 4 platelet count decreased of any duration OR gr 3 platelet count decreased if associated with bleeding (3) gr 3 nonhematologic toxicity except gr 3 fatigue (lasting ≤3 days), diarrhea, nausea, vomiting or rash without standard of care (4) gr 3 or 4 nonhematologic abnormality if medical intervention is required or if it leads to hospitalization or persists for >1 week (5) gr 3 or 4 febrile neutropenia (6) gr 3 or 4 alanine aminotransferase, aspartate aminotransferase and/or bilirubin laboratory value (7) treatment related adverse event (AE) causing study intervention discontinuation during the first 21 days (8) treatment related AE causing intervention administration delay for >14 days during the first 21 days (9) gr 5 toxicity.
The number of participants who experience one or more DLTs in the efficacy phase will be presented.
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Up to ~21 days
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Efficacy Phase: Number of participants who experience one or more AEs
Time Frame: Up to ~43 months
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants who experience one or more AEs in the efficacy phase will be presented.
|
Up to ~43 months
|
Efficacy Phase: Number of participants who discontinue study treatment due to an AE
Time Frame: Up to ~43 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants who discontinue study treatment due to an AE in the efficacy phase will be presented.
|
Up to ~43 months
|
Efficacy Phase: Objective response rate (ORR)
Time Frame: Up to ~43 months
|
ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters).
Responses are according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
|
Up to ~43 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy Phase: Duration of response (DOR)
Time Frame: Up to ~43 months
|
For participants in the analysis population who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), DOR is defined as the time from first documented evidence of CR or PR until progressive disease or death due to any cause, whichever occurs first.
Responses are according to RECIST 1.1 by BICR.
|
Up to ~43 months
|
Efficacy Phase: Progression-free survival (PFS)
Time Frame: Up to ~43 months
|
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first.
Responses are according to RECIST 1.1 by BICR.
|
Up to ~43 months
|
Efficacy Phase: Overall survival (OS)
Time Frame: Up to ~43 months
|
OS is defined as the time from randomization to death due to any cause.
|
Up to ~43 months
|
Efficacy Phase: Clinical benefit rate (CBR)
Time Frame: Up to ~43 months
|
CBR is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) of ≥6 months.
Responses are according to RECIST 1.1 by BICR.
|
Up to ~43 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- Immune Checkpoint Inhibitors
- Pembrolizumab
- Lenvatinib
- Belzutifan
Other Study ID Numbers
- 3475-03A
- MK-3475-03A (Other Identifier: Merck)
- 2019-003609-84 (EudraCT Number)
- 2023-506838-68-00 (Registry Identifier: EU CT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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