Niraparib + Ipilimumab or Nivolumab in Pancreatic Cancer that Has Not Progressed After Platinum Chemotherapy (Parpvax)

Clinicaltrials.gov identifier:
NCT03404960 (https://clinicaltrials.gov/show/NCT03404960)

Principal Investigator: Kim Reiss Binder, MD
Contact: Stacy Cowden by phone: 215-847-4589 or by email or Abramson Cancer Center Clinical Trials Service at 855-216-0098 or by email.

About the Study

The purpose of this study is to look at the effectiveness, safety, and anti-cancer activity of the drug Niraparib (Zejula) combined with one of two immunotherapy agents: Ipilimumab (Yervoy) or Nivolumab (Opdivo) on patients with locally advanced or metastatic pancreatic cancer. Patients in this study must also have previously received Platinum-based chemotherapy without evidence of disease progression. NOTE: This study is no longer enrolling patients.

Type of Study

This is a randomized, open label, two-arm study. Patients will be placed into one of the two study groups by chance. All participating patients will know which combination of therapy drugs they will be receiving during the study.

What the Study Entails

Group 1

Patients will receive Niraparib + Nivolumab.

Niraparib 200mg will be taken orally daily on days 1-21 of each 21-day cycle.
Nivolumab 240mg will be administered via intravenous (IV) on days 1 and 15 of odd-numbered cycles, and on day 8 of even-numbered cycles.

Group 2

Patients will receive Niraparib + Ipilimumab.

Niraparib 200mg will be taken orally daily on days 1-21 of each 21-day cycle.
Ipilimumab 3mg/kg will be administered via IV on day 1 of each cycle, for the first 4 cycles only.

Both Groups

For most of the study outcome measures, patients will be followed up to 42 months, although a few outcomes will be measured for up to 5 years.

Study Site

Philadelphia, PA
University of Pennsylvania, Abramson Cancer Center
Contact: Stacy Cowden by phone: 215-847-4589 or by email.

Principal Investigator: Kim Reiss Binder, MD

This Study is Open To:

Men and women age 18 years or older can participate if they meet the following criteria:

Have locally advanced or metastatic pancreatic cancer.
Have life expectancy of at least 12 weeks.
Received platinum-based treatment (cisplatin, oxaliplatin or carboplatin) for a minimum of 16 weeks without evidence of disease progression.
Agree to blood samples during screening and at the end of treatment.
Have adequate organ function.

This Study is Not Open To:

Patients who had prior treatment with a PARP inhibitor, ipilimumab, nivolumab or other immunotherapy known as an immune checkpoint inhibitor.
Patients with platinum-resistant cancer.
Patients with an active autoimmune disease (Contact the study team to review a list of exceptions).
Patients with a history of lung disease.
Patients who had Grade 3 or 4 anemia, neutropenia (abnormally low count of a type of white blood cell) or thrombocytopenia (low number of platelets) which continued for 4 weeks or more after their most recent treatment.
Patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
Patients with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.

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