A Randomized, Active-Controlled, Blinded, Phase III Clinical Trial of BMS-986213 (Fixed Dose Combination of Relatlimab [anti-LAG-3] and Nivolumab) in Combination with Chemotherapy versus Placebo in Combination with Chemotherapy as First-Line Treatment in Participants with Unresectable, Locally Advanced or Metastatic LAG-3 Postive Gastric or Gastroesophageal Junction Adenocarcinoma

Phase 3

Withdrawn

Conditions: Stomach Cancer
10017991

Registration Number: NL-OMON46592

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

1) Males and Females, * 18 years of age
2) All subjects must have a confirmed diagnosis (using tumour tissue) of unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma. The documentation of GEJ involvement can include biopsy, endoscopy, or imaging.
3) Subject must be previously untreated with systemic treatment including HER 2 inhibitors given as primary therapy for unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma
4) Allowed Prior Therapies: Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy for GC or GEJ cancer are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization. Palliative radiotherapy is allowed and must be completed 2 weeks prior to randomization. Chinese traditional medicines with an approved indication of cancer treatment are permitted as long as the last administration occurred at least 2 weeks prior to randomization.
5) Subject must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment should be performed within 28 days prior to randomization.
6) HER2/neu protein negative LAG3 positive
7) Adequate organ function
8) ECOG performance status score of 0 or 1
9) Tumor tissue must be provided for LAG-3, PD-L1, MSI, TMB biomarker analyses prior to randomization.

Exclusion Criteria

1) LAG3 negative
2) HER2 positive
Medical Conditions
3) Subjects with untreated known brains metastases.
4) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
5) Subjects with active, known, or suspected autoimmune disease.
6) Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
7) All toxicities attributed to prior anti-cancer therapy other than hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4) or baseline before administration of study drug.
8) Subjects with > Grade 1 peripheral neuropathy.
9) Subjects with ascites which cannot be controlled with appropriate interventions
10) Uncontrolled or significant cardiovascular disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* The co-primary outcome measure for this study overall survival and<br /><br>progression free survival (PFS) as assessed by a Blinded Independent Central<br /><br>Review (BICR).<br /><br>o Overall survival is defined as the time between the date of randomization and<br /><br>the date of death. For those without documentation of death, OS will be<br /><br>censored on the last date the participant was known to be alive.<br /><br>o Progression free survival is defined as the time between the date of<br /><br>randomization and the date of the first documented PD per BICR or death due to<br /><br>any cause. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures for this study are as follows:<br /><br>- Objective Response Rate, as assessed by a BICR, per RECIST 1.1<br /><br>- Duration of Response</p><br>