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Clinical Trials/EUCTR2018-001069-18-AT
EUCTR2018-001069-18-AT
Active, not recruiting
Phase 1

A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (anti-LAG-3) and Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-Line Treatment in Patients with Gastric or Gastroesophageal Junction Adenocarcinoma

Bristol-Myers Squibb International Corporation0 sites420 target enrollmentApril 16, 2019
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ConditionsGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOpdivo (100 mg/10 ml)Oxaliplatin Bendalis 5 mg/ml concentrate for solution for infusionCapecitabine Accord 150 mg film-coated tabletsCapecitabine Accord 500 mg film-coated tablets

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
420
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 16, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • •\- Histologically\- or cytologically\-confirmed diagnosis of unresectable, locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
  • •\- No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable, locally advanced, or metastatic GC or GEJ adenocarcinoma
  • •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 294
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 126

Exclusion Criteria

  • •\- Participants with HER2 positive status
  • •\- Participants with known untreated central nervous system (CNS)
  • •\- Uncontrolled or significant cardiovascular disease

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
An Investigational Study of Immunotherapy Combinations withChemotherapy in Patients with Gastric or Gastroesophageal Junction (GEJ)Cancers
EUCTR2018-001069-18-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO420
Active, not recruiting
Phase 1
An Investigational Study of Immunotherapy Combinations with Chemotherapy in Patients with Gastric or Gastroesophageal Junction (GEJ) CancersGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2018-001069-18-NOBristol-Myers Squibb International Corporation420
Active, not recruiting
Phase 1
An Investigational Study of Immunotherapy Combinations with Chemotherapy in Patients with Gastric or Gastroesophageal Junction (GEJ) Cancers
EUCTR2018-001069-18-DEBristol-Myers Squibb International Corporation420
Active, not recruiting
Phase 1
An Investigational Study of Immunotherapy Combinations with Chemotherapy in Patients with Gastric or Gastroesophageal Junction (GEJ) CancersGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2018-001069-18-BEBristol-Myers Squibb International Corporation420
Active, not recruiting
Phase 1
An Investigational Study of Immunotherapy Combinations with Chemotherapy in Patients with Gastric or Gastroesophageal Junction (GEJ) Cancers
EUCTR2018-001069-18-CZBristol-Myers Squibb International Corporation420