An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

Advanced Cancer Clinical Trial

— CheckMate 577  

Official title:

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02743494
• Other study ID #: CA209-577
• Secondary ID: 2015-005556-10
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 14, 2016
• Est. completion date: October 11, 2025

Study information

• Verified date: September 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 794
• Est. completion date: October 11, 2025
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
• Completed pre-operative chemo radiotherapy followed by surgery
• Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection

Exclusion Criteria:

• Diagnosed with cervical esophageal carcinoma
• Diagnosed with Stage IV resectable disease
• Did not receive concurrent chemoradiotherapy prior to surgery
• Participants who have received a live/attenuated vaccine within 30 days of the first treatment Other protocol defined Inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• Nivolumab
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0198	Buenos Aires
Argentina	Local Institution - 0133	Caba
Argentina	Local Institution - 0050	Capital Federal	Buenos Aires
Argentina	Local Institution - 0152	Capital Federal	Buenos Aires
Argentina	Local Institution - 0164	Ciudad Autonoma Buenos Aires	Distrito Federal
Argentina	Local Institution - 0112	Cordoba
Argentina	Local Institution - 0208	Rosario	Santa FE
Argentina	Local Institution - 0051	San Miguel De Tucuman	Tucuman
Argentina	Local Institution - 0207	Viedma	RIO Negro
Australia	Local Institution - 0123	Adelaide	South Australia
Australia	Local Institution - 0200	Blacktown	New South Wales
Australia	Local Institution - 0237	Brisbane	Queensland
Australia	Local Institution - 0072	Clayton	Victoria
Australia	Local Institution - 0098	Gosford	New South Wales
Australia	Local Institution - 0099	Hobart
Australia	Local Institution - 0156	Perth	Western Australia
Australia	Local Institution - 0074	St Leonards	New South Wales
Australia	Local Institution - 0075	Tamworth	New South Wales
Belgium	Local Institution - 0035	Bruxelles
Belgium	Local Institution - 0037	Edegem
Belgium	Local Institution - 0086	Gent
Belgium	Local Institution - 0034	Leuven
Belgium	Local Institution - 0036	Liege
Belgium	Local Institution - 0087	Namur
Brazil	Local Institution - 0061	Barretos	Sao Paulo
Brazil	Local Institution - 0096	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0095	Brasilia	Distrito Federal
Brazil	Local Institution - 0221	Curitiba	Parana
Brazil	Local Institution - 0059	Ijui	RIO Grande DO SUL
Brazil	Local Institution - 0223	Itacorubi, Florianopolis	Santa Catarina
Brazil	Local Institution - 0060	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0065	Rio de Janeiro
Brazil	Local Institution - 0064	Salvador
Brazil	Local Institution - 0222	Sao Jose De Rio Preto	Sao Paulo
Brazil	Local Institution - 0062	Sao Paulo
Brazil	Local Institution - 0063	Sao Paulo
Canada	Local Institution - 0129	Edmonton	Alberta
Canada	Local Institution - 0092	Halifax	Nova Scotia
Canada	Local Institution - 0094	London	Ontario
Canada	Local Institution - 0134	Montreal	Quebec
Canada	Local Institution - 0091	Ottawa	Ontario
Canada	Local Institution - 0109	Quebec
Canada	Local Institution - 0110	Toronto	Ontario
Canada	Local Institution - 0214	Trois-Rivieres	Quebec
Canada	Local Institution - 0093	Vancouver	British Columbia
China	Local Institution - 0240	Beijing	Beijing
China	Local Institution - 0234	Fuzhou	Fujian
China	Local Institution - 0230	Hangzhou	Zhejiang
China	Local Institution - 0238	Hangzhou	Zhejiang
China	Local Institution - 0233	Linhai	Zhejiang
China	Local Institution - 0227	Shanghai	Shanghai
China	Local Institution - 0232	Shanghai
China	Local Institution - 0239	Shanghai	Shanghai
China	Local Institution - 0228	Tianjin
Czechia	Local Institution - 0031	Brno
Czechia	Local Institution - 0029	Hradec Kralove
Czechia	Local Institution - 0030	Olomouc
Denmark	Local Institution - 0166	Aarhus N
France	Local Institution - 0215	Avignon Cedes 9
France	Local Institution - 0121	Dijon Cedex
France	Local Institution - 0117	Lille
France	Local Institution - 0119	Paris
France	Local Institution - 0120	Pessac
France	Local Institution - 0118	Pierre Benite Cedex
France	Local Institution - 0132	Rennes Cedex 9
France	Local Institution - 0149	Rouen
France	Local Institution - 0148	Toulouse
Germany	Local Institution - 0006	Berlin
Germany	Local Institution - 0008	Essen
Germany	Local Institution - 0007	Hamburg
Germany	Local Institution - 0003	Koeln
Germany	Local Institution - 0001	Mainz	Rheinland-Pfalz
Germany	Local Institution - 0017	Marburg
Germany	Local Institution - 0005	Munich
Germany	Local Institution - 0011	Tuebingen
Hong Kong	Local Institution - 0225	Hong Kong
Hungary	Local Institution - 0053	Budapest
Hungary	Local Institution - 0224	Budapest
Hungary	Local Institution - 0052	Debrecen
Hungary	Local Institution - 0057	Kaposvar
Ireland	Local Institution - 0040	Dublin
Ireland	Local Institution - 0038	Galway
Ireland	Local Institution - 0039	Wilton	Cork
Israel	Local Institution - 0146	Haifa
Israel	Local Institution - 0144	Jerusalem
Israel	Local Institution - 0143	Petach Tikva
Israel	Local Institution - 0145	Ramat-gan
Israel	Local Institution - 0142	Tel Aviv
Italy	Local Institution - 0105	Bergamo
Italy	Local Institution - 0104	Milano
Italy	Local Institution - 0137	Milano
Italy	Local Institution - 0106	Reggio Emilia
Italy	Local Institution - 0107	Roma
Japan	Local Institution - 0173	Akita-Shi	Akita
Japan	Local Institution - 0180	Chiba-shi	Chiba
Japan	Local Institution - 0172	Chuo-ku	Tokyo
Japan	Local Institution - 0194	Fukuoka
Japan	Local Institution - 0187	Fukuoka-shi	Fukuoka
Japan	Local Institution - 0189	Gifu-shi	Gifu
Japan	Local Institution - 0183	Hiroshima-Shi	Hiroshima
Japan	Local Institution - 0191	Kagoshima-shi	Kagoshima
Japan	Local Institution - 0181	Kita-gun
Japan	Local Institution - 0186	Kitaadachi-gun	Saitama
Japan	Local Institution - 0190	Koto-ku	Tokyo
Japan	Local Institution - 0184	Kumamoto-shi	Kumamoto
Japan	Local Institution - 0174	Minato-ku	Tokyo
Japan	Local Institution - 0182	Osakasayama	Osaka
Japan	Local Institution - 0192	Sapporo-shi	Hokkaido
Japan	Local Institution - 0196	Sapporo-shi	Hokkaido
Japan	Local Institution - 0188	Sendai-shi	Miyagi
Japan	Local Institution - 0193	Shinjuku-ku	Tokyo
Japan	Local Institution - 0204	Shinjuuku-ku	Tokyo
Japan	Local Institution - 0185	Suita-shi	Osaka
Korea, Republic of	Local Institution - 0175	Seoul
Korea, Republic of	Local Institution - 0176	Seoul
Mexico	Local Institution - 0154	Aguascalientes
Mexico	Local Institution - 0168	Ciudad de Mexico
Mexico	Local Institution - 0084	Distrito Federal
Mexico	Local Institution - 0127	Leon, Guanajato	Guanajuato
Mexico	Local Institution - 0085	Tlalpan	Distrito Federal C.p.
Mexico	Local Institution - 0212	Tuxtla Gutierrez	Chiapas
Netherlands	Local Institution - 0089	Amsterdam
Netherlands	Local Institution - 0042	Groningen
Netherlands	Local Institution - 0043	Maastrict
Peru	Local Institution - 0195	Callao
Peru	Local Institution - 0088	Lima
Peru	Local Institution - 0141	Lima
Peru	Local Institution - 0162	Lima
Poland	Local Institution - 0083	Gliwice
Poland	Local Institution - 0138	Krakow
Poland	Local Institution - 0139	Lublin
Poland	Local Institution - 0082	Poznan	Wielkopolskie
Poland	Local Institution - 0081	Warszawa
Puerto Rico	Local Institution - 0097	San Juan
Romania	Local Institution - 0167	Baia Mare
Romania	Local Institution - 0163	Bucharest
Romania	Local Institution - 0197	Bucuresti
Romania	Local Institution - 0103	Cluj-napoca
Romania	Local Institution - 0028	Craiova
Romania	Local Institution - 0135	Floresti
Russian Federation	Local Institution - 0213	Cheboksary
Russian Federation	Local Institution - 0125	Moscow
Russian Federation	Local Institution - 0209	Saint-Petersburg
Russian Federation	Local Institution - 0136	St. Petersburg
Singapore	Local Institution - 0218	Singapore
Singapore	Local Institution - 0219	Singapore
Spain	Local Institution - 0078	Barcelona
Spain	Local Institution - 0079	Cordoba
Spain	Local Institution - 0077	Madrid
Spain	Local Institution - 0080	Madrid
Switzerland	Local Institution - 0018	Basel
Switzerland	Local Institution - 0047	St Gallen
Taiwan	Local Institution - 0177	Taichung
Taiwan	Local Institution - 0178	Tainan
Taiwan	Local Institution - 0179	Taipei
Turkey	Local Institution - 0160	Adana
Turkey	Local Institution - 0161	Erzurum
Turkey	Local Institution - 0157	Istanbul
United Kingdom	Local Institution - 0243	Cardiff
United Kingdom	Local Institution - 0045	London	Greater London
United Kingdom	Local Institution - 0202	London
United Kingdom	Local Institution - 0203	London	Greater London
United Kingdom	Local Institution - 0046	Southampton	Hampshire
United Kingdom	Local Institution - 0169	Sutton	Surrey
United Kingdom	Local Institution - 0049	Withington	Manchester
United States	Local Institution - 0101	Allentown	Pennsylvania
United States	Local Institution - 0151	Aurora	Colorado
United States	Local Institution - 0025	Baltimore	Maryland
United States	Local Institution - 0055	Boston	Massachusetts
United States	Local Institution - 0170	Boston	Massachusetts
United States	Local Institution - 0171	Boston	Massachusetts
United States	Local Institution - 0217	Boston	Massachusetts
United States	Local Institution - 0205	Bronx	New York
United States	Local Institution - 0033	Charlotte	North Carolina
United States	Local Institution - 0153	Chicago	Illinois
United States	Local Institution - 0056	Cleveland	Ohio
United States	Local Institution - 0216	Dallas	Texas
United States	Local Institution - 0248	Dallas	Texas
United States	Local Institution - 0247	Denver	Colorado
United States	Local Institution - 0024	Durham	North Carolina
United States	Local Institution - 0113	Fort Myers	Florida
United States	Local Institution - 0058	Hackensack	New Jersey
United States	Local Institution - 0012	Houston	Texas
United States	Local Institution - 0131	Jacksonville	Florida
United States	Local Institution - 0026	Los Angeles	California
United States	Local Institution - 0069	Madison	Wisconsin
United States	Local Institution - 0226	Miami	Florida
United States	Local Institution - 0111	Nashville	Tennessee
United States	Local Institution - 0130	Nashville	Tennessee
United States	Local Institution - 0066	Neptune	New Jersey
United States	Local Institution - 0032	New York	New York
United States	Local Institution - 0022	Pensacola	Florida
United States	Local Institution - 0048	Philadelphia	Pennsylvania
United States	Local Institution - 0116	Pittsburgh	Pennsylvania
United States	Local Institution - 0165	Portland	Oregon
United States	Local Institution - 0027	Saint Louis	Missouri
United States	Local Institution - 0114	Saint Petersburg	Florida
United States	Local Institution - 0068	San Francisco	California
United States	Pacific Hematology Oncology Associates	San Francisco	California
United States	Local Institution - 0067	Seattle	Washington
United States	Local Institution - 0241	Seattle	Washington
United States	Local Institution - 0250	Tucson	Arizona
United States	Local Institution - 0054	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Peru,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Singapore,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival (DFS)	Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first.; Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment	From randomization to the date of recurrence or death (up to approximately 46 months)
Secondary	Overall Survival (OS)	Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.	From randomization to the date of death (up to approximately 46 months)
Secondary	Overall Survival Rate	Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization	From randomization to 1, 2 and 3 years later

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls