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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05231122 | Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer | PHASE2 | RECRUITING | 80 | — | — | Mar 12, 2024 | Dec 30, 2026 | Mar 16, 2026 | 2 | United States |
Evaluated according to National Cancer Institute Common Terminology Criteria for adverse events (NCI CTCAE) version (v)5.0. Will be summarized by cohort and grade using frequencies and relative frequencies.
Will be summarized by cohort (with or without CDX 1140) using frequencies and relative frequencies, with the ORR estimated using 90% confidence intervals obtained by Jeffrey's prior method. The final analysis will be performed on all n=80 (40 in each cohort) evaluable patients; and if the p-value is less than or equal to 0.10, then the triplet regimen will be considered superior with respect to response.
| Arm | Type | Description |
|---|---|---|
| Arm I (pembrolizumab, bevacizumab) | ACTIVE_COMPARATOR | Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity. |
| Arm II (pembrolizumab, bevacizumab, CDX-1140) | EXPERIMENTAL | Patients receive pembrolizumab IV over 30 minutes, bevacizumab IV over 30-90 minutes, and CDX-1140 IV over 90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Anti-CD40 Agonist Monoclonal Antibody CDX-1140 | BIOLOGICAL | Given IV |
| Bevacizumab | BIOLOGICAL | Given IV |
| Pembrolizumab | BIOLOGICAL | Given IV |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
| Questionnaire Administration | OTHER | Ancillary studies |
Inclusion Criteria: * Age \>= 18 years of age. * Recurrent serous (low grade or high grade), endometrioid, or clear cell recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Participant can be either platinum-sensitive or platinum-resistant, no more than 4 prior lines of tr...