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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04993677 | A Study of SEA-CD40 Given With Other Drugs in Cancers | PHASE2 | COMPLETED | 77 | — | — | Oct 6, 2021 | Nov 25, 2024 | May 11, 2025 | 29 | United States, Canada +4 |
cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions.
| Arm | Type | Description |
|---|---|---|
| Melanoma Arm | EXPERIMENTAL | SEA-CD40 + pembrolizumab |
| NSCLC Arm | EXPERIMENTAL | SEA-CD40 + pembrolizumab + pemetrexed + carboplatin |
| Name | Type | Description |
|---|---|---|
| SEA-CD40 | DRUG | Given into the vein (IV; intravenously); schedule is cohort-specific |
| pembrolizumab (KEYTRUDA®) | DRUG | Given by IV; schedule is cohort-specific. |
| pemetrexed | DRUG | Given by IV on Day 1 of each 21-day cycle. |
| carboplatin | DRUG | Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long. |
Inclusion Criteria: * Histologically or cytologically confirmed unresectable malignancy defined as one of the following: * Cohort 1: Relapsed and/or refractory metastatic melanoma * Uveal/ocular melanoma is excluded * Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 t...