A study comparing immunotherapy combinations with chemotherapy and chemotherapy alone in participants with advanced LAG-3 positive gastric and gastroesophageal junction (GEJ) cancers

Phase 1

• Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma; MedDRA version: 20.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004896-30-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-27
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2420

Inclusion Criteria

- Participants must have histologically- or cytologically-confirmed diagnosis of unresectable, locally advanced, or metastatic gastric or GEJ adenocarcinoma
- Available tumor tissue for biomarker analysis; participants must have LAG-3 positive expression
- Participants must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria
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 1694
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 726

Exclusion Criteria

- Participants known HER2 positive status
- Participants with untreated known CNS metastases
- Participants with ascites which cannot be controlled with appropriate interventions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified