Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
- Trial number:
- NCT03937219
- Trial phase:
- 3
- Study type:
- Targeted therapy, Immunotherapy
- Overall status:
- Recruiting
Study start date
June, 2019
Scientific title
A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk
Summary
This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.
Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria. Measurable disease per RECIST 1.1 as determined by the Investigator. Measurable disease must be outside the radiation field if radiation therapy was previously administered. Karnofsky Performance Status (KPS) ≥ 70%. Adequate organ and marrow function.
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Intervention model description:
Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio., Masking:
Triple, Subject masked:
Yes, Investigator masked:
Yes, Outcomes assessor masked:
Yes,
Conditions
Renal Cell Carcinoma
Other study ID numbers
XL184-313
Choose trial site (177)
Exelixis Clinical Site #116
La Jolla, CA 92093, USA
Exelixis Clinical Site #166
Orange, CA, USA
Exelixis Clinical Site #58B
Washington, DC 20016, USA
Exelixis Clinical Site #29
Boca Raton, FL 33486, USA
Exelixis Clinical Site #44
Miami, FL 33176, USA
Exelixis Clinical Site #3
GA-3, Atlanta, GA 30318, USA
Exelixis Clinical Site #95
Chicago, IL 60612, USA
Exelixis Clinical Site #69
Pine Point, ME 04074, USA
Exelixis Clinical Site #58A
Baltimore, MD 21287, USA
Exelixis Clinical Site #7B
Boston, MA 02114, USA
Exelixis Clinical Site #7A
Boston, MA 02215, USA
Exelixis Clinical Site #7C
Boston, MA 02215, USA
Exelixis Clinical Site #6
Burlington, MA 01805, USA
Exelixis Clinical Site #15
Detroit, MI 48201, USA
Exelixis Clinical Site #24
Kansas City, MO 64132, USA
Exelixis Clinical Site #4
St. Louis, MO 63110, USA
Exelixis Clinical Site #2
Omaha, NE 68130, USA
Exelixis Clinical Site #159
W 159th St, New York, NY 10032, USA
Exelixis Clinical Site #8
New York, NY 10065, USA
Exelixis Clinical Site #19
Syracuse, NY 13210, USA
Exelixis Clinical Site #101
Charlotte, NC 28204, USA
Exelixis Clinical Site #107
Portland, OR 97239, USA
Exelixis Clinical Site #12
Pittsburgh, PA 15232, USA
Exelixis Clinical Site #102
Charleston, SC 29425, USA
Exelixis Clinical Site #5
Myrtle Beach, SC 29572, USA
Exelixis Clinical Site #10
Nashville, TN 37203, USA
Exelixis Clinical Site #38
Nashville, TN 37232, USA
Exelixis Clinical Site #64
Fairfax, VA 22031, USA
Exelixis Clinical Site #57
Seattle, WA 98109, USA
Exelixis Clinical Site #1
Spokane, WA 99208, USA
Exelixis Clinical Site #13
Madison, WI 53792, USA
Exelixis Clinical Site #153
Buenos Aires Province, Argentina
Exelixis Clinical Site #109
Rosario, Santa Fe Province, Argentina
Exelixis Clinical Site #73
T4000 San Miguel de Tucumán, Tucumán, Argentina
Exelixis Clinical Site #63
Buenos Aires, Argentina
Exelixis Clinical Site #54
Buenos Aires, Argentina
Exelixis Clinical Site #110
Buenos Aires, Argentina
Exelixis Clinical Site #120
X5004 Córdoba, Cordoba, Argentina
Exelixis Clinical Site #32
Albury NSW 2640, Australia
Exelixis Clinical Site #48
Darlinghurst NSW 2010, Australia
Exelixis Clinical Site #35
Kogarah NSW 2217, Australia
Exelixis Clinical Site #27
North Ryde NSW 2113, Australia
Exelixis Clinical Site #16
Port Macquarie NSW 2444, Australia
Exelixis Clinical Site #21
Randwick NSW 2031, Australia
Exelixis Clinical Site #33
St Leonards NSW 2065, Australia
Exelixis Clinical Site #17
South Brisbane QLD 4101, Australia
Exelixis Clinical Site #14
Woolloongabba QLD 4102, Australia
Exelixis Clinical Site #18
Adelaide SA 5000, Australia
Exelixis Clinical Site #11
North Adelaide SA 5006, Australia
Exelixis Clinical Site #9
Lucas VIC 3350, Australia
Exelixis Clinical Site #23
State Route 23, Box Hill South VIC 3128, Australia
Exelixis Clinical Site #26
Subiaco WA 6008, Australia
Exelixis Clinical Site #98
2700, Austria
Exelixis Clinical Site #76
4020 Linz, Austria
Exelixis Clinical Site #103
Linz, Austria
Exelixis Clinical Site #75
5020 Salzburg, Austria
Exelixis Clinical Site #126
Vienna, Austria
Exelixis Clinical Site #112
1000 Brussels, Belgium
Exelixis Clinical Site #146
Hasselt, Belgium
Exelixis Clinical Site #156
Liège, Belgium
Exelixis Clinical Site #154
Santa Efigenia, Belo Horizonte - State of Minas Gerais, 30130-090, Brazil
Exelixis Clinical Site #155
Bom Retiro, Curitiba - State of Paraná, 80530-010, Brazil
Exelixis Clinical Site #140
Menino Deus, Porto Alegre - RS, 90110-270, Brazil
Exelixis Clinical Site #163
Porto Alegre, RS, Brazil
Exelixis Clinical Site #158
Historical Centre, Porto Alegre - RS, 90050-170, Brazil
Exelixis Clinical Site #168
Jardim Campo Redondo, Barretos - SP, 14784-400, Brazil
Exelixis Clinical Site #162
São José do Rio Preto, State of São Paulo, Brazil
Exelixis Clinical Site #165
Centro, Rio de Janeiro - State of Rio de Janeiro, 20230-130, Brazil
Exelixis Clinical Site #119
Bela Vista, São Paulo - State of São Paulo, 01323-001, Brazil
Exelixis Clinical Site #141
Bela Vista, São Paulo - State of São Paulo, 01327-001, Brazil
Exelixis Clinical Site #157
Liberdade, São Paulo - State of São Paulo, 01509, Brazil
Exelixis Clinical Site #22
Calgary, AB T2N 4N2, Canada
Exelixis Clinical Site #105
Winnipeg, MB R3E 0V9, Canada
Exelixis Clinical Site #46
Ottawa, ON K1H 8L6, Canada
Exelixis Clinical Site #25
Toronto, ON M4N 3M5, Canada
Exelixis Clinical Site #113
Montreal, QC H3T 1E2, Canada
Exelixis Clinical Site #85
Temuco, Araucania, Chile
Exelixis Clinical Site #91
Santiago, Santiago Metropolitan Region, Chile
Exelixis Clinical Site #100
Santiago, Santiago Metropolitan Region, Chile
Exelixis Clinical Site #89
Králová, 783 91 Medlov, Czechia
Exelixis Clinical Site #79
Liberec, Czechia
Exelixis Clinical Site #114
Prague 4, Czechia
Exelixis Clinical Site #118
Prague 5, Czechia
Exelixis Clinical Site #50
50, Helsinki, Finland
Exelixis Clinical Site #56
33520 Tampere, Finland
Exelixis Clinical Site #52
20520 Turku, Finland
Exelixis Clinical Site #87
25000 Besançon, France
Exelixis Clinical Site #86
Bordeaux, France
Exelixis Clinical Site #82
Pompano Beach, FL 33076, USA
Exelixis Clinical Site #71
72000 Le Mans, France
Exelixis Clinical Site #78
Lyon, France
Exelixis Clinical Site #80
Montpellier, France
Exelixis Clinical Site #66
6 Rue de Belgique, 06000 Nice, France
Exelixis Clinical Site #150
75015 Paris, France
Exelixis Clinical Site #65
Reims, France
Exelixis Clinical Site #125
Rennes, France
Exelixis Clinical Site #128
67000 Strasbourg, France
Exelixis Clinical Site #90
67200 Strasbourg, France
Exelixis Clinical Site #42
Toulouse, France
Exelixis Clinical Site #67
54500 Vandœuvre-lès-Nancy, France
Exelixis Clinical Site #37
94800 Villejuif, France
Exelixis Clinical Site #127
69120 Heidelberg, Germany
Exelixis Clinical Site #115
72076 Tübingen, Germany
Exelixis Clinical Site #117
60596 Frankfurt am Main, Germany
Exelixis Clinical Site #139
48149 Münster, Germany
Exelixis Clinical Site #171
Münster, Germany
Exelixis Clinical Site #164
55131 Mainz, Germany
Exelixis Clinical Site #137
Jena, Germany
Exelixis Clinical Site #124
01307 Dresden, Germany
Exelixis Clinical Site #28
Unit B, 16/F, Emperor Watch and Jewellery Centre, No, 8 Russell St, Causeway Bay, Hong Kong
Exelixis Clinical Site #136
Sha Tin, Hong Kong
Exelixis Clinical Site #111
Tuen Mun, Hong Kong
Exelixis Clinical Site #39
Budapest, Hungary
Exelixis Clinical Site #51
Pécs, 7624 Hungary
Exelixis Clinical Site #88
Be'er Sheva, Israel
Exelixis Clinical Site #81
Haifa, Israel
Exelixis Clinical Site #84
Jerusalem, Israel
Exelixis Clinical Site #121
Kefar Sava, Israel
Exelixis Clinical Site #97
Petah Tikva, Israel
Exelixis Clincal Site #129
Ramat Gan, Israel
Exelixis Clinical Site #41
47014 Meldola, Province of Forlì-Cesena, Italy
Exelixis Clinical Site #70
48018 Faenza, Province of Ravenna, Italy
Exelixis Clinical Site #170
10060 Candiolo, Metropolitan City of Turin, Italy
Exelixis Clinical Site #47
52100 Arezzo, Province of Arezzo, Italy
Exelixis Clinical Site #60
41124 Modena, Province of Modena, Italy
Exelixis Clinical Site #61
35128 Padua, Province of Padua, Italy
Exelixis Clinical Site #59
27100 Pavia, Province of Pavia, Italy
Exelixis Clinical Site #104
06132 Perugia, Province of Perugia, Italy
Exelixis Clinical Site #68
05100 Terni, Province of Terni, Italy
Exelixis Clinical Site #147
Seongnam-si, Gyeonggi-do, South Korea
Exelixis Clinical Site #145
Yangsan-si, Gyeongsangnam-do, South Korea
Exelixis Clinical Site #143
Seoul, South Korea
Exelixis Clinical Site #151
Seoul, South Korea
Exelixis Clinical Site #152
Seoul, South Korea
Exelixis Clinical Site #123
Aguascalientes, Mexico
Exelixis Clinical Site #167
León, Guanajuato, Mexico
Exelixis Clinical Site #169
Colli Urbano, 45070 Zapopan, Jal., Mexico
Exelixis Clinical Site #134
Del Carmen, 64710 Monterrey, N.L., Mexico
Exelixis Clinical Site #132
Centro, 68000 Oaxaca de Juárez, Oax., Mexico
Exelixis Clinical Site #133
México, 97125 Mérida, Yuc., Mexico
Exelixis Clinical Site #160
Insurgentes San Borja, 03100 Ciudad de México, CDMX, Mexico
Exelixis Clinical Site #131
Querétaro, Mexico
Exelixis Clinical Site #161
Santiago de Querétaro, Qro., Mexico
Exelixis Clinical Site #144
1105 AZ Netherlands
Exelixis Clinical Site #108
6229 HX Maastricht, Netherlands
Exelixis Clinical Site #149
3015 GD Rotterdam, Netherlands
Exelixis Clinical Site #122
Waikato 3204, New Zealand
Exelixis Clinical Site #148
Newtown, Wellington 6021, New Zealand
Exelixis Clinical Site #31
21-500 Biala Podlaska, Poland
Exelixis Clinical Site #62
Bydgoszcz, Poland
Exelixis Clinical Site #135
80-219 Gdańsk, Poland
Exelixis Clinical Site #99
Otwock, Poland
Exelixis Clinical Site #83
Poznań, Poland
National University Hospital 119074
Singapore 119074
Exelixis Clinical Site #40
Singapore 169610
Exelixis Clinical Site #53
15706 Santiago de Compostela, A Coruña, Spain
Exelixis Clinical Site #45
31008 Pamplona, Navarre, Spain
Exelixis Clinical Site #43
08035 Barcelona, Spain
Exelixis Clinical Site #36
08036 Barcelona, Spain
Exelixis Clinical Site #49
Córdoba, Spain
Exelixis Clinical Site #34
28009 Madrid, Spain
Exelixis Clinical Site #94
28040 Madrid, Spain
Exelixis Clinical Site #20
28041 Madrid, Spain
Exelixis Clinical Site #55
28050 Madrid, Spain
Exelixis Clinical Site #96
Oviedo, Asturias, Spain
Exelixis Clinical Site #74
46009 Valencia, Spain
Exelixis Clinical Site #174
Kaohsiung City, Taiwan
Exelixis Clinical Site #142
Taichung, North District, Taichung City, Taiwan
Exelixis Clinical Site #138
Taipei, Taiwan
Exelixis Clinical Site #173
Taoyuan City, Taiwan
Exelixis Clinical Site #72
Cambridge CB2 0QQ, UK
Exelixis Clinical Site #93
Great Western Rd, Glasgow G12 0YN, UK
Exelixis Clinical Site #30
London EC1A 7BE, UK
Exelixis Clinical Site #106
London SE1 9RT, UK
Exelixis Clinical Site #172
Hammersmith, London W6 8RF, UK
Exelixis Clinical Site #92
Wilmslow Rd, Manchester M20 4BX, UK
Exelixis Clinical Site #130
Sketty, Swansea SA2 8QA, UK