Study to compare how long subjects with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab compared with subjects receiving chemotherapy standard of care, oxaliplatin plus fluoropyrimidine.

• Register: EUCTR
• Last refreshed on: 17 October 2016
• Main ID: EUCTR2016-001018-76-ES
• Date of registration: 05/08/2016
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb International Corporation
• Public title: Study to compare how long subjects with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab compared with subjects receiving chemotherapy standard of care, oxaliplatin plus fluoropyrimidine.
• Scientific title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab versus Oxaliplatin plus Fluoropyrimidine in Subjects with Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer (CheckMate 649: CHECKpoint pathway and nivoluMab clinical Trial Evaluation 649) - CheckMate 649
• Date of first enrolment: 10/10/2016
• Target sample size: 1000
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001018-76
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Brazil, Canada, Chile, China, Colombia, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Peru, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: GCT-SU
• Affiliation: Bristol-Myers Squibb International Corporation

• Name: GCT-SU
• Affiliation: Bristol-Myers Squibb International Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
- Male or Female at least 18 years of
age
- Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that
is advanced or has spread out
- Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their
disease within the last 6 months
- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion criteria:
- Presence of tumor cells in the brain or spinal cord that have not been treated
- Active known or suspected autoimmune disease
- Any serious or uncontrolled medical disorder or active infection (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Any positive test result for hepatitis B or C indicating acute or chronic infection


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Gastric or Gastroesophageal Junction Cancer
MedDRA version: 19.0 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: NIVOLUMAB - 10ml vial
Product Code: BMS-936558
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: 946414-94-4
Current Sponsor code: BMS-936558-01
Other descriptive name: BMS-936558, MDX1106, ONO-4538
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Product Name: IPILIMUMAB
Product Code: BMS-734016
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IPILIMUMAB
CAS Number: 477202-00-9
Current Sponsor code: BMS-734016
Other descriptive name: BMS734016
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: Oxaliplatin Kabi
Product Name: Oxaliplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: Oxaliplatin Bendalis
Product Name: Oxaliplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: Capecitabine Accord
Product Name: Capecitabine Accord
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Capecitabine
Other descriptive name: CAPECITABINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Capecitabine Accord
Product Name: Capecitabine Accord
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Capecitabine
Other descriptive name: CAPECITABINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Oncofolic
Product Name: folinic acid
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Folinic Acid
Other descriptive name: FOLINIC ACID
Concentration unit: mg/ml milligram(s)/millilitre
Concentration

Primary Outcome(s)

Secondary Objective: - To compare OS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in all randomized
subjects with advanced or metastatic GC or GEJ cancer
- To compare PFS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in subjects with advanced or metastatic GC or GEJ cancer whose tumors express PD-L1
- To compare PFS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in all randomized
subjects with advanced or metastatic GC or GEJ cancer
- To compare TTSD as assessed using the Gastric Cancer Subscale (GaCS) of the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) of nivolumab plus ipilimumab vs oxaliplatin plus fluoropyrimidine in subjects with advanced or metastatic GC or GEJ cancer whose tumors express PD-L1
- To compare TTSD as assessed using GaCS of FACT-Ga of nivolumab plus ipilimumab vs oxaliplatin plus fluoropyrimidine in all randomized subjects with advanced or metastatic GC or GEJ cancer.

Main Objective: To compare OS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in subjects with advanced or metastatic GC or GEJ cancer whose tumors express PD-L1.

Primary end point(s): Overall survival (OS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in subjects with PDL1 expressing tumors

Timepoint(s) of evaluation of this end point: Approximately 35 months after the first patient is randomized

Secondary Outcome(s)

Secondary end point(s): - OS of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in all randomized subjects
- Progressionfree Survival (PFS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in subjects with PDL1 expressing tumors and all randomized subjects.
-Time to Symptom Deterioration in a patient reported outcomes questionnaire (GaCS), in subjects with PDL1 expressing tumors and all randomized subjects

Timepoint(s) of evaluation of this end point: Approximately 35 months after the first patient is randomized

Secondary ID(s)

CA209-649

Source(s) of Monetary Support

Bristol-Myers Squibb International Corporation