Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Niraparib+ Nivolumab · 1 trial · 1 indication
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...
Niraparib+Nivolumab is an investigational combination being studied for pancreatic adenocarcinoma. It is a small molecule therapy in Phase 1 clinical development. The combination is being evaluated in patients with progression-free pancreatic adenocarcinoma after platinum-based chemotherapy.
Niraparib+Nivolumab is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical research on this combination for the treatment of pancreatic adenocarcinoma.
Niraparib+Nivolumab is in Phase 1 clinical development. It is an investigational combination and has not been approved by the FDA. One Phase 1 clinical trial has been completed for this therapy in pancreatic adenocarcinoma.
Niraparib+Nivolumab is associated with clinical trial NCT03404960, titled 'Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy.' This Phase 1 trial was completed in the United States with 104 participants.
No, Niraparib+Nivolumab is a specific combination of niraparib and nivolumab. The clinical trial NCT03404960 also evaluated niraparib plus ipilimumab as a separate treatment arm. These are distinct combination therapies being studied in the same trial.