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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03970252 | Nivolumab in Combination With Chemotherapy Pre-Surgery in Treating Patients With Borderline Resectable Pancreatic Cancer | EARLY_PHASE1 | COMPLETED | 28 | — | — | Jul 24, 2019 | May 25, 2024 | Aug 9, 2024 | 1 | United States |
Descriptive statistics with frequency and proportion will be used.
Descriptive statistics with frequency and proportion will be used.
| Arm | Type | Description |
|---|---|---|
| Treatment (nivolumab, mFOLFIRINOX) | EXPERIMENTAL | Patients receive nivolumab IV over 60 minutes on day 1. Patients also receive fluorouracil IV over 10 minutes and over 46 hours, irinotecan hydrochloride IV over 90-120 minutes, leucovorin calcium IV over 120 minutes, and oxaliplatin IV over 120 minutes on days 1 and 15. Treatments repeat every 28 days for 3-6 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients with resectable disease undergo surgery. Within 8-12 weeks after surgery, patients with successful resection may receive 6 additional cycles of fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Fluorouracil | DRUG | Given IV |
| Irinotecan | DRUG | Given IV |
| Irinotecan Hydrochloride | DRUG | Given IV |
| Leucovorin | DRUG | Given IV |
| Leucovorin Calcium | DRUG | Given IV |
| Nivolumab | BIOLOGICAL | Given IV |
| Oxaliplatin | DRUG | Given IV |
| Therapeutic Conventional Surgery | PROCEDURE | Undergo surgery |
Inclusion Criteria: * Histologically confirmed pancreatic adenocarcinoma * One of the following: * Borderline resectable disease. There are multiple definitions of borderline resectable pancreatic ductal adenocarcinoma (PDAC) including the MD Anderson definition and the criteria developed during...