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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03404960 | Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy | PHASE1 | COMPLETED | 104 | — | — | Jan 31, 2018 | Oct 9, 2024 | Oct 10, 2025 | 1 | United States |
The PFS6 rate will be estimated using the Kaplan-Meier method, and the 95% confidence interval will be estimated from the Kaplan-Meier curve. The null hypothesis is that the PFS6 rate in this population of subjects is 44%. Progressive disease is defined as at least a 20% increase in the sum of all the longest diameter (LD) of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression. Target lesions assessed according to RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Niraparib + Nivolumab |
| Arm B | EXPERIMENTAL | Niraparib + Ipilimumab |
| Name | Type | Description |
|---|---|---|
| Niraparib + Nivolumab | DRUG | Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle. |
| Niraparib + Ipilimumab | DRUG | Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only. |
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with locally advanced or metastatic disease 2. ≥18 years of age 3. Patients must be able to understand the study procedures and agree to participate in the study by providing written informed con...