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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02537444 | Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191) | PHASE2 | COMPLETED | 78 | — | — | Nov 1, 2015 | Oct 1, 2018 | Sep 25, 2019 | 2 | United States |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
| Arm | Type | Description |
|---|---|---|
| Regimen 1 | EXPERIMENTAL | Drug: acalabrutinib monotherapy |
| Regimen 2 | EXPERIMENTAL | Drug: Combination of acalabrutinib and pembrolizumab |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib | DRUG | - |
| acalabrutinib and pembrolizumab combination | DRUG | - |
Inclusion Criteria: * Women ≥ 18 years of age. * Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma. * Progression of disease after the most recent anticancer treatment. At least 1 prior chemotherapy regimen must have included a taxane. * Platinu...