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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03499899 | A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer | PHASE2 | COMPLETED | 88 | — | — | Jul 2, 2018 | Nov 24, 2021 | Jan 30, 2023 | 33 | United States, Argentina +15 |
Overall response rate (ORR) is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 based on investigator's assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| Arm | Type | Description |
|---|---|---|
| LAG525 + PDR001 | EXPERIMENTAL | Participants received LAG525 and PDR001 administered as infusion once every 3 weeks |
| LAG525 + PDR001 + carboplatin | EXPERIMENTAL | Participants received LAG525, PDR001 and carboplatin administered as infusion once every 3 weeks. |
| LAG525 + carboplatin | EXPERIMENTAL | Participants received LAG525 and carboplatin administered as infusion once every 3 weeks |
| Name | Type | Description |
|---|---|---|
| LAG525 | DRUG | LAG525 was a concentrate for solution for intravenous infusion, came in 100mg vials as a liquid formulation for infusion and was dosed at 400mg every 21 days. For all arms, LAG525 was infused first |
| PDR001 | DRUG | Spartalizumab was a concentrate for solution for intravenous infusion, came in 100mg vials as a liquid formulation for infusion and was dosed at 300mg every 21 days. Spartalizumab was infused after LAG525 |
| Carboplatin | DRUG | Carboplatin was a concentrate for solution for intravenous infusion, came in 100mg/mL and was dosed per area under the curve (AUC) 6 every 21 days. Carboplatin was infused once LAG525 and spartalizumab infusions were completed |
Inclusion Criteria: * Had advanced (loco-regionally recurrent not amenable to curative therapy or metastatic) breast cancer * Had adequate bone marrow and organ function. * Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Had measurable disease, i.e., at least one mea...