Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,082
Countries
10
Sites
41
Subjects with resected adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer
To compare disease-free survival (DFS) of nivolumab versus placebo in subjects with resected esophageal cancer (EC), or gastro-esophageal junction (GEJ) cancer
Key facts
- Sponsor
- Bristol Myers Squibb International Corporation
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Jun 2016 → 8 Nov 2024
- Decision date (initial)
- 2024-04-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509360-24-00
- EudraCT number
- 2015-005556-10
- WHO UTN
- U1111-1177-2665
- ClinicalTrials.gov
- NCT02743494
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Others, Therapy, Prophylaxis, Efficacy
To compare disease-free survival (DFS) of nivolumab versus placebo in subjects with resected esophageal cancer (EC), or gastro-esophageal junction (GEJ) cancer
Secondary objectives 2
- To compare overall survival (OS) of nivolumab versus placebo in subjects with resected EC or GEJ cancer.
- To evaluate 1, 2, and 3 year survival rates of nivolumab versus placebo in subjects with resected EC or GEJ cancer.
Conditions and MedDRA coding
Subjects with resected adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10062878 | Gastrooesophageal cancer | 100000004864 |
| 25.1 | PT | 10030191 | Oesophageal squamous cell carcinoma stage III | 100000004864 |
| 20.0 | PT | 10030143 | Oesophageal adenocarcinoma stage II | 100000004864 |
| 20.0 | PT | 10030144 | Oesophageal adenocarcinoma stage III | 100000004864 |
| 21.0 | LLT | 10015362 | Esophageal cancer | 10029104 |
| 25.1 | PT | 10030190 | Oesophageal squamous cell carcinoma stage II | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- EMA Regulatory Submissions Expediter Limited
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- subjects diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
- subjects completed pre-operative chemoradiotherapy followed by surgery
- subjects diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection
Exclusion criteria 3
- subjects diagnosed with cervical esophageal carcinoma
- subjects diagnosed with Stage IV resectable disease
- subjects who did not receive concurrent chemoradiotherapy prior to surgery
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Disease-free survival is the primary endpoint of this study. Disease-free survival is the time between randomization date and first date of recurrence or death, whichever occurs first.
Secondary endpoints 1
- Overall survival and overall survival rates are secondary endpoints. -Overall Survival is time between the date of randomization and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive. -The overall survival rate at 1, 2, and 3 years is defined as the probability that a subject is alive at 1, 2, and 3 years, respectively, following randomization.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941375 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 6240 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol Myers Squibb International Corporation
- Sponsor organisation
- Bristol Myers Squibb International Corporation
- Address
- Terhulpsesteenweg 185
- City
- Watermaal-Bosvoorde
- Postcode
- 1170
- Country
- Belgium
Scientific contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- GSM-CT
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| PPD Development LP ORG-100011560
|
Richmond, United States | Other |
| Myriad RBM Inc. ORG-100045698
|
Austin, United States | Other |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Data management, E-data capture |
Locations
10 EU/EEA countries · 41 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 38 | 6 |
| Czechia | Ended | 8 | 2 |
| Denmark | Ended | 6 | 1 |
| France | Ended | 60 | 8 |
| Germany | Ended | 53 | 7 |
| Ireland | Ended | 9 | 3 |
| Netherlands | Ended | 21 | 3 |
| Poland | Ended | 50 | 5 |
| Romania | Ended | 15 | 2 |
| Spain | Ended | 15 | 4 |
| Rest of world
United Kingdom, Singapore, Israel, Brazil, New Zealand, Australia, Hong Kong, Argentina, United States, Russian Federation, Mexico, China, Canada, Switzerland, Peru
|
— | 807 | — |
Investigational sites
Universitair Ziekenhuis Gent
Gastro-Enterology, Corneel Heymanslaan 10, 9000, Gent
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Oncology, Place Louise Godin 15, 5000, Namur
UZ Leuven
Gastro-enterology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Medical Oncology, Drie Eikenstraat 655, 2650, Edegem
CHU De Liege
Gastro-Enterology, Bld Du Douzieme-De-Ligne 1, 4000, Liege
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Masarykuv Onkologicky Ustav
Klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno-Stred
University Hospital Olomouc
Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Assistance Publique Hopitaux De Paris
Hepato-Gastroenterology, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Toulouse
Digestive medical Oncology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Sainte Catherine Institut Du Cancer Avignon-Provence
Radiation Oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Centre Hospitalier Universitaire De Lille
Digestive Surgery, 1 Place De Verdun, 59000, Lille
CHU De Rouen
Hepato-Gastroenterology, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Groupe D’Etude Des Lymphomes De L’Adulte
General and oncological surgery, 165 Chemin Du Grand Revoyet, 69495, Pierre Benite Cedex
Centre Hospitalier Universitaire De Rennes
Digestive System Diseases, 2 Rue Henri Le Guilloux, 35000, Rennes
Klinikum rechts der Isar der TU Muenchen AöR
III. Medizinische Klinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
University Medical Center Hamburg-Eppendorf
Onkologisches Zentrum, Martinistrasse 52, Eppendorf, Hamburg
Charite Universitaetsmedizin Berlin KöR
Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
Philipps-Universitaet Marburg
Klinik für Innere Medizin Schwerpunkt Hämatologie, Onkologie und Immunologie, Baldingerstrasse, 35043, Marburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Ambulanz für Gastrointestinale Tumore, I. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
KEM I Evang. Kliniken Essen-Mitte gGmbH
Lehrkrankenhaus der Universität Duisburg-Essen, Henricistrasse 92, Huttrop, Essen
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
National University Of Ireland
Clinical Trials Unit, Newcastle Road, H91 YR71, Galway
Beaumont Hospital
Cancer Clinical Trials & Research Unit, Beaumont Road, Beaumont, Dublin 9
Cork University Hospital
Oncology, Wilton, T12 DC4A, Cork
University Hospital Maastricht
Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
Universitair Medisch Centrum Groningen
Oncology, Hanzeplein 1, 9713 GZ, Groningen
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Oddział Kliniczny Chirurgii Klatki Piersiowej, Ul. Pradnicka 80, 31-202, Cracow
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddzial Onkologii Klinicznej i Doswiadczalnej, Ul. Grunwaldzka 16/18, 60-780, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
II Klinika Radioterapii i Chemioterapii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Gastroenterologii Onkologicznej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
II Katedra i Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego, Al. Solidarnosci 8, 20-841, Lublin
Radiotherapy Center Cluj S.R.L.
Oncologie Medicala, Strada Oitelor 7, 040278, Bucharest
Focus Lab Plus S.R.L.
Oncologie Medicala, Strada Petre Negulescu 30 Section 2, 22548, Bucharest
Hospital Universitario Hm Sanchinarro
Oncologia, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Gregorio Maranon
Oncologia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital General Universitario Reina Sofia
Oncologia, Avenida Menendez Pidal S/n, 14004, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2016-12-06 | 2024-11-07 | 2016-12-12 | 2019-08-01 | |
| Czechia | 2016-06-16 | 2024-10-25 | 2016-08-03 | 2019-08-09 | |
| Denmark | 2016-10-13 | 2024-10-24 | 2017-01-25 | 2019-11-07 | |
| France | 2016-08-30 | 2024-11-07 | 2016-09-27 | 2019-08-08 | |
| Germany | 2016-10-28 | 2024-11-07 | 2016-11-08 | 2019-08-20 | |
| Ireland | 2016-11-04 | 2024-11-07 | 2017-01-11 | 2020-07-16 | |
| Netherlands | 2016-11-07 | 2024-11-05 | 2016-12-05 | 2019-07-01 | |
| Poland | 2016-09-12 | 2024-11-06 | 2016-09-14 | 2019-08-08 | |
| Romania | 2016-11-18 | 2024-11-07 | 2016-11-21 | 2019-07-05 | |
| Spain | 2016-10-28 | 2024-11-05 | 2018-09-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2023-509360-24-00_Final Summary of Results SUM-104960
|
2025-11-04T17:19:34 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2023-509360-24-00_Lay Person Summary of Results | 2025-09-15T18:19:19 | Submitted | Laypersons Summary of Results |
| 2023-509360-24-00_Lay Person Summary of Results_GER_DE | 2025-09-23T13:47:26 | Submitted | Laypersons Summary of Results |
| 2023-509360-24-00_Lay Person Summary of Results_DK_DAN | 2025-09-24T15:49:23 | Submitted | Laypersons Summary of Results |
| 2023-509360-24-00_Lay Person Summary of Results_PL | 2025-09-30T17:32:00 | Submitted | Laypersons Summary of Results |
| 2023-509360-24-00_Lay Person Summary of Results_DU_BE | 2025-10-31T14:34:11 | Submitted | Laypersons Summary of Results |
| 2023-509360-24-00_Lay Person Summary of Results_FR_BE | 2025-10-31T14:36:29 | Submitted | Laypersons Summary of Results |
| 2023-509360-24-00_Lay Person Summary of Results_FR_FR | 2025-10-31T14:37:31 | Submitted | Laypersons Summary of Results |
| 2023-509360-24-00_Lay Person Summary of Results_DU_NL | 2025-10-31T14:38:52 | Submitted | Laypersons Summary of Results |
| 2023-509360-24-00_Lay person summary of results_CZ | 2025-11-07T18:21:45 | Submitted | Laypersons Summary of Results |
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 2023-509360-24-00_Lay Person Summary of Results | N/A |
| Laypersons summary of results (for publication) | 2023-509360-24-00_Lay person summary of results_CZ | NA |
| Laypersons summary of results (for publication) | 2023-509360-24-00_Lay Person Summary of Results_DK_DAN | 1 |
| Laypersons summary of results (for publication) | 2023-509360-24-00_Lay Person Summary of Results_DU_BE | 1 |
| Laypersons summary of results (for publication) | 2023-509360-24-00_Lay Person Summary of Results_DU_NL | 1 |
| Laypersons summary of results (for publication) | 2023-509360-24-00_Lay Person Summary of Results_FR_BE | 1 |
| Laypersons summary of results (for publication) | 2023-509360-24-00_Lay Person Summary of Results_FRA | 1 |
| Laypersons summary of results (for publication) | 2023-509360-24-00_Lay Person Summary of Results_GER_DE | 1 |
| Laypersons summary of results (for publication) | 2023-509360-24-00_Lay Person Summary of Results_PL | N/A |
| Protocol (for publication) | D1_Protocol_2023-509360-24-00_redacted | 04 |
| Summary of results (for publication) | 2023-509360-24-00_Final Summary of Results | N/A |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis EU CT 2023-509360-24_PL | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis_ENG 2023-509360-24-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ES 2023-509360-24-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-509360-24_CZ_CS_public | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BE_EU CT_2023-509360-24-00_DE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BE_EU CT_2023-509360-24-00_FR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BE_EU CT_2023-509360-24-00_NL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NL_EU CT_2023-509360-24-00_NL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-509360-24_FR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_EU CT 2023-509360-24 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-09 | Poland | Acceptable 2024-03-13
|
2024-03-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-29 | Acceptable 2024-03-13
|
2024-04-29 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-13 | Poland | Acceptable 2024-09-20
|
2024-09-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-08 | Poland | Acceptable 2024-11-25
|
2024-11-28 |