Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab · 1 trial · 2 indications
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...
Pembrolizumab is being studied as a neoadjuvant and adjuvant treatment for resectable Pancreatic Ductal Adenocarcinoma (PDAC). It is given with or without defactinib following chemotherapy. The drug is in Phase 2 clinical development and is investigational, not yet approved for this indication.
Pembrolizumab targets the PD-1 receptor on T cells. By blocking PD-1, it helps the immune system recognize and attack cancer cells. In the context of resectable Pancreatic Ductal Adenocarcinoma (PDAC), it is being evaluated in combination with defactinib following chemotherapy.
Pembrolizumab is being developed by Verastem, Inc., which trades under the ticker VSTM. The company is conducting a Phase 2 clinical trial of the drug in resectable Pancreatic Ductal Adenocarcinoma (PDAC).
Pembrolizumab is in Phase 2 clinical development for resectable Pancreatic Ductal Adenocarcinoma (PDAC). It is an investigational drug and has not been approved by the FDA for this indication. The Phase 2 trial has been completed.
Pembrolizumab is being studied in a Phase 2 clinical trial with the identifier NCT03727880. The trial is titled 'Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma.' It enrolled 28 participants in the United States and has been completed.