Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03662659 | An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers | PHASE2 | COMPLETED | 274 | — | — | Oct 16, 2018 | Jan 18, 2024 | Feb 5, 2025 | 79 | United States, Argentina +15 |
The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions
The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.
| Arm | Type | Description |
|---|---|---|
| BMS-986213 + investigator's choice chemotherapy | EXPERIMENTAL | BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX |
| Nivolumab + investigator's choice chemotherapy | EXPERIMENTAL | Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX |
| Name | Type | Description |
|---|---|---|
| BMS-986213 | BIOLOGICAL | Relatlimab + Nivolumab specified dose on specified days |
| Nivolumab | BIOLOGICAL | Specified dose on specified days |
| XELOX | DRUG | Oxaliplatin + capecitabine |
| FOLFOX | DRUG | Oxaliplatin + leucovorin + fluorouracil |
| SOX | DRUG | Oxaliplatin + tegafur/gimeracil/oteracil potassium |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Histologically- or cytologically-confirmed diagnosis of unresectable and eithe...