A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

Carcinoma, Renal Cell Clinical Trial

— CheckMate 914  

Official title:

A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138512
• Other study ID #: CA209-914
• Secondary ID: 2016-004502-34
• Status: Completed
• Phase: Phase 3
• Start date: July 7, 2017
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

Description:

The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1653
• Est. completion date: February 1, 2024
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
• Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following:

pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0

• Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
• Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
• Women must agree to follow methods of contraception, if applicable

Exclusion Criteria:

• Participants with an active known or suspected autoimmune disease
• Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
• History of allergy or hypersensitivity to study drug components
• Participants with a condition requiring systemic treatment with corticosteroids
• Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Biological:
• nivolumab
Specified dose on specified days
• ipilimumab
Specified dose on specified days

Drug:
• nivolumab placebo
Specified dose on specified days
• ipilimumab placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0232	Bariloche	RIO Negro
Argentina	Local Institution - 0179	Buenos Aires
Argentina	Local Institution - 0099	Caba
Argentina	Local Institution - 0178	Capital Federal	Buenos Aires
Argentina	Local Institution - 0126	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Local Institution - 0203	Ciudad Autónoma De Buenos Aires	Buenos Aires
Argentina	Local Institution - 0096	Cordoba
Argentina	Local Institution - 0098	Cordoba
Argentina	Local Institution - 0095	Mar Del Plata	Buenos Aires
Argentina	Local Institution - 0208	Mar Del Plata	Buenos Aires
Argentina	Local Institution - 0173	Rio Cuarto	Cordoba
Argentina	Local Institution - 0164	San Juan
Argentina	Local Institution - 0097	Tucuman
Australia	Local Institution - 0033	Clayton	Victoria
Australia	Local Institution - 0034	Elizabeth Vale	South Australia
Australia	Local Institution - 0214	Heidelberg	Victoria
Australia	Local Institution - 0215	Macquarie Park	New South Wales
Australia	Local Institution - 0031	Murdoch	Western Australia
Australia	Local Institution - 0032	Northmead	New South Wales
Australia	Local Institution - 0036	Randwick	New South Wales
Australia	Local Institution - 0113	South Brisbane	Queensland
Australia	Local Institution - 0213	Southport	Queensland
Australia	Local Institution - 0035	St Leonards	New South Wales
Austria	Local Institution - 0068	Linz
Austria	Local Institution - 0084	Wien
Belgium	Local Institution - 0064	Anderlecht
Belgium	Local Institution - 0058	Gent	Oost-Vlaanderen
Belgium	Local Institution - 0060	Hasselt
Belgium	Local Institution - 0059	Liege
Brazil	Local Institution - 0043	Barretos	Sao Paulo
Brazil	Local Institution - 0045	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0047	Brasilia	Distrito Federal
Brazil	Local Institution - 0046	Ijui	RIO Grande DO SUL
Brazil	Local Institution - 0048	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0160	Rio de Janeiro
Brazil	Local Institution - 0050	Sao Paulo
Brazil	Local Institution - 0044	São Paulo	SAO Paulo
Canada	Local Institution - 0042	Montreal	Quebec
Canada	Local Institution - 0087	Oshawa	Ontario
Canada	Local Institution - 0040	Rimouski	Quebec
Canada	Local Institution - 0086	Saint John	New Brunswick
Canada	Local Institution - 0112	Toronto	Ontario
Canada	Local Institution - 0041	Vancouver	British Columbia
Chile	Local Institution - 0223	La Serena	Coquimbo
Chile	Local Institution	Santiago	Metropolitana
Chile	Local Institution - 0221	Santiago	Metropolitana
Chile	Local Institution - 0246	Santiago	Metropolitana
Chile	Local Institution - 0222	Vina del Mar	Valparaiso
China	Local Institution - 0147	Beijing	Beijing
China	Local Institution - 0153	Beijing	Beijing
China	Local Institution - 0159	Beijing	Beijing
China	Local Institution - 0145	Changchun	Jilin
China	Local Institution - 0142	Chengdu	Sichuan
China	Local Institution - 0143	Chengdu	Sichuan
China	Local Institution - 0132	Fuzhou	Fujian
China	Local Institution - 0134	Guangzhou
China	Local Institution - 0141	Guangzhou	Guangdong
China	Local Institution - 0131	Hangzhou	Zhejiang
China	Local Institution - 0157	Hangzhou	Zhejiang
China	Local Institution - 0140	Nanchang	Jiangxi
China	Local Institution - 0138	Nanjing	Jiangsu
China	Local Institution - 0139	Nanjing
China	Local Institution - 0137	Shanghai	Shanghai
China	Local Institution - 0148	Shanghai	Shanghai
China	Local Institution - 0152	Shanghai	Shanghai
China	Local Institution - 0166	Shanghai	Shanghai
China	Local Institution - 0176	Shanghai
China	Local Institution - 0175	Tianjin	Tianjin
China	Local Institution - 0133	Wuhan	Hubei
China	Local Institution - 0194	Wuhan	Hebei
China	Local Institution - 0144	Xi'an	Shan3xi
China	Local Institution - 0146	Yantai	Shandong
Colombia	Local Institution - 0229	Bogotá
Colombia	Local Institution - 0230	Floridablanca
Colombia	Local Institution - 0227	Medellin	Antioquia
Colombia	Local Institution - 0226	Pereira
Colombia	Local Institution - 0228	Valledupar	Cesar
Czechia	Local Institution - 0094	Hradec Kralove
Czechia	Local Institution - 0025	Olomouc
France	Local Institution - 0083	Besançon Cedex
France	Local Institution - 0080	Bordeaux
France	Local Institution - 0082	La Roche-Sur-Yon Cedex 9
France	Local Institution - 0116	Lyon Cedex 08
France	Local Institution - 0079	Marseille Cedex 9
France	Local Institution - 0198	Paris
France	Local Institution - 0081	Rennes
France	Local Institution - 0077	Strasbourg
France	Local Institution - 0115	Toulouse Cedex 9
France	Local Institution - 0150	Tours Cedex
France	Local Institution - 0078	Vandoeuvre Les Nancy
France	Local Institution - 0076	Villejuif
Germany	Local Institution - 0053	Aachen
Germany	Local Institution - 0103	Essen
Germany	Local Institution - 0052	Hamburg
Germany	Local Institution - 0061	Hannover
Germany	Local Institution - 0231	Hannover
Germany	Local Institution - 0062	Jena
Germany	Local Institution - 0102	Munich
Germany	Local Institution - 0054	Nuernberg
Germany	Local Institution - 0055	Rostock
Germany	Local Institution - 0217	Tubingen	Baden-Württemberg
Germany	Local Institution - 0101	Wuerzburg
Italy	Local Institution - 0105	Arezzo
Italy	Local Institution - 0172	Cremona
Italy	Local Institution - 0106	Napoli
Italy	Local Institution - 0107	Parma
Italy	Local Institution - 0109	Roma
Italy	Local Institution - 0108	Verona
Japan	Local Institution - 0188	Adachi-ku	Tokyo
Japan	Local Institution - 0119	Bunkyo-ku	Tokyo
Japan	Local Institution - 0189	Bunkyo-ku	Tokyo
Japan	Local Institution - 0158	Chiba-shi	Chiba
Japan	Local Institution - 0121	Fukuoka-shi	Fukuoka
Japan	Local Institution - 0193	Hirosaki-shi	Aomori
Japan	Local Institution - 0165	Hiroshima
Japan	Local Institution - 0130	Kamigyo-ku	Kyoto
Japan	Local Institution - 0167	Kobe-shi	Hyogo
Japan	Local Institution - 0216	Kumamoto-shi	Kumamoto
Japan	Local Institution - 0123	Nagasaki-shi	Nagasaki
Japan	Local Institution - 0120	Niigata-shi	Niigata
Japan	Local Institution - 0125	Osakasayama-shi	Osaka
Japan	Local Institution - 0156	Sapporo-shi	Hokkaido
Japan	Local Institution - 0149	Shinjuku-Ku	Tokyo
Japan	Local Institution - 0168	Shiwa-gun	Iwate
Japan	Local Institution - 0122	Suita-shi	Osaka
Japan	Local Institution - 0162	Tokushima-shi	Tokushima
Japan	Local Institution - 0129	Toyoake Shi	Aichi
Japan	Local Institution - 0191	Tsukuba-shi	Ibaraki
Japan	Local Institution - 0163	Ube-shi	Yamaguchi
Japan	Local Institution - 0192	Wakayama
Japan	Local Institution - 0127	Yamagata
Japan	Local Institution - 0128	Yokohama-shi	Kanagawa
Mexico	Local Institution - 0089	Chihuahua
Mexico	Local Institution - 0151	Ciudad de Mexico	Distrito Federal
Mexico	Local Institution - 0104	Mazatlan	Sinaloa
Mexico	Local Institution - 0196	Merida	Yucatan
Mexico	Local Institution - 0088	Monterrey, NL
Mexico	Local Institution - 0169	San Luis Potosi
Mexico	Local Institution - 0242	Tijuana	BAJA California
Mexico	Local Institution - 0111	Tlalpan	Distrito Federal
Mexico	Local Institution - 0195	Torreón	Coahuila
Mexico	Local Institution - 0197	Tuxtla Gutierrez	Chiapas
Mexico	Local Institution - 0110	Zapopan	Jalisco
Netherlands	Local Institution - 0066	Amsterdam
Netherlands	Local Institution - 0067	Rotterdam
Netherlands	Local Institution - 0092	Zwolle
Poland	Local Institution - 0155	Bydgoszcz
Poland	Local Institution - 0038	Wroclaw
Romania	Local Institution - 0243	Bucharest
Romania	Local Institution - 0247	Cluj
Romania	Local Institution - 0200	Cluj-Napoca
Romania	Local Institution - 0199	Craiova
Romania	Local Institution - 0202	Ia?i
Russian Federation	Local Institution - 0065	Moscow
Russian Federation	Local Institution - 0170	Novosibirsk
Russian Federation	Local Institution - 0021	Saint-Petersburg
Russian Federation	Local Institution - 0171	Saint-Petersburg
Singapore	Local Institution - 0017	Singapore
Singapore	Local Institution - 0018	Singapore	Central Singapore
Spain	Local Institution - 0204	Barcelona
Spain	Local Institution - 0206	Barcelona
Spain	Local Institution - 0124	Caceres
Spain	Local Institution - 0207	Cordoba
Spain	Local Institution - 0118	Lugo
Spain	Local Institution - 0114	Madrid
Spain	Local Institution - 0205	Madrid
Spain	Local Institution - 0117	Sabadell
Spain	Local Institution - 0161	Sevilla
Switzerland	Local Institution - 0218	Chur
Switzerland	Local Institution - 0219	Sankt Gallen
Switzerland	Local Institution - 0225	Zuerich
Turkey	Local Institution - 0209	Ankara
Turkey	Local Institution	Istanbul
Turkey	Local Institution - 0210	Istanbul
United Kingdom	Local Institution - 0063	Manchester
United Kingdom	Local Institution - 0071	Northwood
United Kingdom	Local Institution - 0073	Preston
United Kingdom	Local Institution - 0075	Southampton	Hampshire
United Kingdom	Local Institution - 0072	Swansea
United States	Local Institution - 0010	Allentown	Pennsylvania
United States	Local Institution - 0016	Athens	Georgia
United States	Local Institution - 0185	Aurora	Colorado
United States	Local Institution - 0019	Birmingham	Alabama
United States	Local Institution - 0007	Buffalo	New York
United States	Local Institution - 0013	Chattanooga	Tennessee
United States	Local Institution	Chicago	Illinois
United States	Local Institution - 0005	Chicago	Illinois
United States	Local Institution - 0008	Columbus	Ohio
United States	Local Institution - 0057	Fairfax	Virginia
United States	Local Institution - 0014	Greenville	South Carolina
United States	Local Institution - 0012	Howell	New Jersey
United States	Local Institution - 0180	Los Angeles	California
United States	Local Institution - 0186	Los Angeles	California
United States	Local Institution - 0183	Nashville	Tennessee
United States	Local Institution - 0001	New York	New York
United States	Local Institution - 0181	New York	New York
United States	Local Institution - 0009	Portland	Oregon
United States	Local Institution - 0006	Saint Louis	Missouri
United States	Local Institution - 0002	San Francisco	California
United States	Local Institution - 0056	Springdale	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Czechia,  France,  Germany,  Italy,  Japan,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Singapore,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS) as assessed by BICR (Part A and Part B)		Up to 10 years
Secondary	Overall Survival (OS) (Part A and Part B)		Up to 10 years
Secondary	Incidence of Adverse Events (AEs) (Part A and Part B)		Up to 100 days after the last dose of study treatment
Secondary	Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C)		Up to 10 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting