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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03727880 | Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma | PHASE2 | COMPLETED | 28 | — | — | Jun 4, 2019 | Jan 15, 2025 | Feb 4, 2026 | 3 | United States |
Percent of subjects with a pathologic complete response (pCR) per the tumor regression grade scores established by the College of American Pathologist: Grade 0= complete response (no viable cancer cells), Grade 1= near complete response (single cells or rare small groups of cancer cells), Grade 2= partial response (residual tumor with evidence of regression), or Grade 3= no response (extensive residual tumor with no evidence of regression).
| Arm | Type | Description |
|---|---|---|
| Arm A - Pembrolizumab and Defactinib | EXPERIMENTAL | - |
| Arm B - Pembrolizumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Following standard of care neoadjuvant chemotherapy, subjects will receive two doses of pembrolizumab (200mg) IV 3 weeks apart prior to surgery. After surgery, subjects will receive adjuvant standard of care chemotherapy. Following adjuvant chemotherapy, subjects will receive 8 doses of pembrolizumab (200mg) IV 3 weeks apart. |
| Defactinib | DRUG | Following 2 cycles of standard of care neoadjuvant chemotherapy, subjects will receive 400 mg defactinib twice a day up until 2 days preceding their surgery (approximately 6 weeks) during the immunotherapy cycles with pembrolizumab. After surgery, subjects will receive adjuvant standard of care chemotherapy. Following adjuvant chemotherapy, subjects will receive 400mg defactinib twice a day for 24 weeks. |
Inclusion Criteria: * Age ≥18 years. * Has pancreatic ductal adenocarcinoma * Has resectable disease at the time of diagnosis * Has not received any systemic therapy for pancreatic ductal adenocarcinoma * Has stage ≤ IIb disease at time of diagnosis and enrollment * Elevated tumor marker, CA (carbo...