A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Intervention:

  • Biological: Nivolumab
  • Drug: Cabozantinib
  • Drug: Sunitinib
  • Biological: Ipilimumab

Purpose: The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03141177

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Progression Free Survival (PFS) per blinded independent central review (BICR)
  • Time Frame: Up to 21 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall Survival (OS)
  • Time Frame: Up to 64 months
  • Safety Issue:
  • Measure: Objective Response Rate (ORR)
  • Time Frame: Approximately 16 months
  • Safety Issue:
  • Measure: Incidence of adverse events (AEs)
  • Time Frame: Up to 64 months
  • Safety Issue:
  • Measure: Incidence of Serious Adverse Events (SAEs)
  • Time Frame: Up to 64 months
  • Safety Issue:

Estimated Enrollment: 630

Study Start Date: July 11, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
  • No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy Exclusion Criteria:
  • Any active CNS metastases
  • Any active, known or suspected autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Other protocol defined inclusion/

Exclusion Criteria:

  • Any active CNS metastases
  • Any active, known or suspected autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Other protocol defined inclusion/exclusion criteria could apply

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • please email:

Locations:

  • Southern Cancer Center, Inc.
  • Daphne Alabama 36526 United States
  • Cancer Treatment Centers of America-Western
  • Goodyear Arizona 85338 United States
  • University of Arizona Cancer Center
  • Tucson Arizona 85724-5024 United States
  • CBCC Global Research, Inc.
  • Bakersfield California 93309 United States
  • Local Institution
  • Los Angeles California 90017 United States
  • UCLA Hematology Oncology
  • Los Angeles California 90095 United States
  • Cancer Care Associates Medical Group, Inc.
  • Redondo Beach California 90277 United States
  • Coastal Integrative Cancer Care
  • San Luis Obispo California 93401 United States
  • Central Coast Med Oncology
  • Santa Maria California 93454 United States
  • University Of Colorado Cancer Center
  • Aurora Colorado 80045 United States
  • University Cancer Blood Ctr
  • Athens Georgia 30607 United States
  • Southeastern Regional Medical Center - CTCA
  • Newnan Georgia 30265 United States
  • Rush University Med Ctr
  • Chicago Illinois 60612 United States
  • Midwestern Regional Medical Center
  • Zion Illinois 60099 United States
  • Ft. Wayne Med Onco-Hema Inc
  • Fort Wayne Indiana 46845 United States
  • Cancer Center Of Kansas
  • Wichita Kansas 67214 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Local Institution
  • Boston Massachusetts 02215 United States
  • University Of Michigan
  • Ann Arbor Michigan 48109 United States
  • HCA Midwest Division
  • Kansas City Missouri 64132 United States
  • Washington University School Of Medicine
  • Saint Louis Missouri 63110 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89169 United States
  • Roswell Park Cancer Institute
  • Buffalo New York 14263 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Local Institution
  • Cincinnati Ohio 45230 United States
  • Oregon Health & Science University
  • Portland Oregon 97239 United States
  • Lehigh Valley Health Network
  • Allentown Pennsylvania 18103 United States
  • Tennessee Oncology, PLLC
  • Nashville Tennessee 37203 United States
  • Texas Oncology
  • Austin Texas 78731 United States
  • Baylor Sammons Cancer Center
  • Dallas Texas 75246 United States
  • MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • Local Institution
  • Midland Texas 79701 United States
  • Local Institution
  • Plano Texas 75093 United States
  • Texas Cancer Center - Sherman
  • Sherman Texas 75090 United States
  • Local Institution
  • Salt Lake City Utah 84112 United States
  • Virginia Oncology Associates
  • Norfolk Virginia 23502 United States
  • Local Institution
  • Seattle Washington 98195 United States
  • Hospital Italiano De Buenos Aires
  • Ciudad Autonoma De Buenos Aire Buenos Aires 1181 Argentina
  • Local Institution
  • Córdoba Cordoba 5016 Argentina
  • Clinica Viedma S.A.
  • Viedma RIO Negro 8500 Argentina
  • Centro Medico San Roque
  • San Miguel De Tucuman Tucuman Argentina
  • Centro De Diagnostico Urologico S.R.L.
  • Buenos Aires 1120 Argentina
  • Local Institution
  • Caba 1426 Argentina
  • Instituto Oncologico De Cordoba
  • Cordoba 5000 Argentina
  • Clinica Privada Universitaria Reina Fabiola
  • Cordoba X5004FHP Argentina
  • The Kinghorn Cancer Centre
  • Darlinghurst New South Wales 2010 Australia
  • Macquarie University
  • North Ryde New South Wales Australia
  • Local Institution
  • Sydney New South Wales 2139 Australia
  • Local Institution
  • Westmead New South Wales 2145 Australia
  • Royal Brisbane and Women's Hospital
  • Herston Queensland 4006 Australia
  • Local Institution
  • South Brisbane Queensland 4101 Australia
  • Tasman Oncology Research Pty Ltd
  • Southport Queensland 4215 Australia
  • Cabrini Hospital
  • Malvern Victoria 3144 Australia
  • Affinity Clinical Research Services Pty Ltd
  • Doubleview Western Australia 6018 Australia
  • Local Institution
  • Elizabeth Vale 5112 Australia
  • PERSONAL Oncologia de Precisao e Personalizada
  • Belo Horizonte Minas Gerais 30130-090 Brazil
  • Associacao Hospital de Caridade Ijui
  • Ijui RIO Grande DO SUL 98700-000 Brazil
  • Hospital Sao Lucas Da Pucrs
  • Porto Alegre RIO Grande DO SUL 90610-000 Brazil
  • Hospital Nossa Senhora Da Conceicao
  • Porto Alegre RIO Grande DO SUL 91350-200 Brazil
  • Fundacao Pio Xii Hosp Cancer De Barretos
  • Barretos SAO Paulo 14784-400 Brazil
  • Local Institution
  • Rio De Janeiro 20231-050 Brazil
  • Hospital Alemao Oswaldo Cruz
  • Sao Paulo 01323-020 Brazil
  • Local Institution
  • Sao Paulo 05652-900 Brazil
  • Bradford Hill Centro de Investigaciones Clinicas
  • Recoleta Santiago DE Chile Chile
  • Klinika onkologie a radioterapie
  • Hradec Kralove 500 05 Czechia
  • Onkologicka klinika
  • Olomouc 779 00 Czechia
  • Local Institution
  • Bordeaux 33075 France
  • Local Institution
  • Caen 14000 France
  • Local Institution
  • Lyon Cedex 08 69373 France
  • Local Institution
  • Marseille Cedex 9 13009 France
  • Local Institution
  • Montpellier Cedex 34295 France
  • Local Institution
  • Nantes 44202 France
  • Local Institution
  • Paris 75015 France
  • Local Institution
  • Strasbourg Cedex 67091 France
  • Local Institution
  • Toulouse 31100 France
  • Local Institution
  • Villejuif 94805 France
  • Local Institution
  • Aachen 52074 Germany
  • Universitaetsklinikum Bonn
  • Bonn 53127 Germany
  • Klinik Essen-Mitte
  • Essen 45136 Germany
  • Universitaetsklinikum Jena
  • Jena 07747 Germany
  • Klinikum Rechts Der Isar Der Tum
  • Muenchen 81675 Germany
  • Klinikum Nuernberg Nord, Urologische Klinik
  • Nuernberg 90419 Germany
  • Uniklinik Tuebingen
  • Tuebingen 72076 Germany
  • Alexandra General Hospital
  • Athens 11528 Greece
  • Local Institution
  • Thessaloniki 54645 Greece
  • Local Institution
  • Haifa 3109601 Israel
  • Local Institution
  • Kfar Saba 44281 Israel
  • Local Institution
  • Petah Tikva 49414 Israel
  • Local Institution
  • Ramat Gan 52621 Israel
  • Ospedale S. Donato - Usl 8
  • Arezzo 52100 Italy
  • Ospedale San Raffaele
  • Milano 20132 Italy
  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
  • Napoli 80131 Italy
  • I.O.V. Istituto Oncologico Veneto Ircss
  • Padova Padova Italy
  • Comitato Etico ICS Maugeri
  • Pavia 27100 Italy
  • Local Institution
  • Pavia 27100 Italy
  • Local Institution
  • Terni 05100 Italy
  • Local Institution
  • Akita-shi Akita 0108543 Japan
  • Local Institution
  • Hirosaki-shi Aomori 036-8563 Japan
  • Local Institution
  • Chiba-shi Chiba 260-8717 Japan
  • Local Institution
  • Sapporo-shi Hokkaido 0608648 Japan
  • Local Institution
  • Sapporo Hokkaido 0608543 Japan
  • Local Institution
  • Kobe Hyogo 6500017 Japan
  • Local Institution
  • Morioka-shi Iwate 0208505 Japan
  • Local Institution
  • Yokohama-shi Kanagawa 2360004 Japan
  • Local Institution
  • Yokohama Kanagawa 2418515 Japan
  • Local Institution
  • Nagasaki-shi Nagasaki 8528501 Japan
  • Local Institution
  • Niigata-shi Niigata 9518520 Japan
  • Local Institution
  • Okayama-shi Okayama 7008558 Japan
  • Local Institution
  • Osaka-shi Osaka 5418567 Japan
  • Local Institution
  • Osaka-shi Osaka 5458586 Japan
  • Local Institution
  • Osakasayama-shi Osaka 5898511 Japan
  • Local Institution
  • Suita-shi Osaka 5650871 Japan
  • Local Institution
  • Hidaka-shi Saitama 3501298 Japan
  • Local Institution
  • Tokushima-shi Tokushima 7708503 Japan
  • Local Institution
  • Arakawa-ku Tokyo 1668567 Japan
  • Local Institution
  • Bunkyo-ku Tokyo 1138519 Japan
  • Local Institution
  • Minato-ku Tokyo 1058470 Japan
  • Local Institution
  • Shinjuku-Ku Tokyo 1608582 Japan
  • Local Institution
  • Yamagata-shi Yamagata 9909585 Japan
  • Local Institution
  • Bunkyo-ku 1138603 Japan
  • Local Institution
  • Fukuoka 812-8582 Japan
  • Comite Mexicano para la Prevenion de la Osteoporosis A.C.
  • Ciudad de Mexico Distrito Federal 06100 Mexico
  • Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.
  • Mexico Distrito Federal 14080 Mexico
  • Instituto Nacional De Cancerologia
  • Tlalpan Distrito Federal 14080 Mexico
  • Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.
  • Zapopan Jalisco 45030 Mexico
  • Local Institution
  • Monterrey Nuevo LEON 64000 Mexico
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Monterrey Nuevo LEON 64460 Mexico
  • Merida Investigacion Clincia
  • Merida Yucatan 97125 Mexico
  • Local Institution
  • Monterrey, NL 64060 Mexico
  • Hospital Medica Tec 100
  • Queretaro 76000 Mexico
  • WSS w Bialej Podlaskiej
  • Biala Podlaska 21-500 Poland
  • Ambulatorium Chemioterapii
  • Bydgoszcz 85-796 Poland
  • Wojewodzkie Centrum Onkologii
  • Gdansk 80-219 Poland
  • Instit. Prof.Dr.Ion Chiricuta
  • Cluj-Napoca 400015 Romania
  • Sf. Nectarie Oncology Center
  • Craiova 200347 Romania
  • Local Institution
  • Moscow 115478 Russian Federation
  • Local Institution
  • Moscow 117997 Russian Federation
  • Local Institution
  • Moscow 125284 Russian Federation
  • Local Institution
  • Nizhniy Novgorod 603109 Russian Federation
  • Local Institution
  • Saint-Petersburg 197758 Russian Federation
  • Local Institution
  • A Coru?a 15006 Spain
  • Local Institution
  • Barcelona 08035 Spain
  • Local Institution
  • Madrid 28009 Spain
  • Local Institution
  • Madrid 28041 Spain
  • H. U. Marques de Valdecilla
  • Santander 39008 Spain
  • Hosp. Univ. Virgen Del Rocio
  • Sevilla 41013 Spain
  • Local Institution
  • Valencia 46014 Spain
  • Local Institution
  • Ankara 06018 Turkey
  • Local Institution
  • Ankara 06590 Turkey
  • Local Institution
  • Ankara 06800 Turkey
  • Local Institution
  • Antalya 07070 Turkey
  • Local Institution
  • Denizli 20070 Turkey
  • Local Institution
  • Edirne 22100 Turkey
  • Local Institution
  • Istanbul 34300 Turkey
  • Local Institution
  • London EC1A 7BE United Kingdom
  • Local Institution
  • Manchester M20 4BX United Kingdom
  • Local Institution
  • Newcastle Upon Tyne NE7 7DN United Kingdom
  • Local Institution
  • Truro TR1 3LJ United Kingdom

View trial on ClinicalTrials.gov


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