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Label indication OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or… FDA label
Also known as Opdualag, Nivolumab-relatlimab FDC, Relopduo
BMS-986213 · 2 trials · 4 indications
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 |
| Cohort A: BMS-986213 Fixed Dose Combination | EXPERIMENTAL | - |
| Cohort B: BMS-986213 Fixed Dose Combination | EXPERIMENTAL | - |
| 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...
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BMS-986213 is an investigational small molecule being studied in oncology. It has been evaluated in clinical trials for advanced solid tumors and gastric cancer, including cancer of the stomach and esophagogastric junction. The drug is in clinical development and is not approved for any use.
BMS-986213 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company has sponsored clinical trials of the drug in patients with gastric cancer and advanced solid tumors.
BMS-986213 is in Phase 1 clinical development. It has been studied in early-stage trials, including a completed Phase 1 study in Chinese participants with advanced solid tumors. The drug remains investigational and has not received regulatory approval.
BMS-986213 has been studied in two completed trials. NCT03662659 was a Phase 2 study of immunotherapy combinations with chemotherapy in gastric or gastroesophageal junction cancers, enrolling 274 participants. NCT05134948 was a Phase 1 study of relatlimab and nivolumab fixed-dose combination in Chinese participants with advanced solid tumors, enrolling 24 participants.