Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Disease Progression

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Nivolumab

Ipilimumab

Poly(ADP-ribose) Polymerase Inhibitors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.

Niraparib + Nivolumab

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.

Niraparib + Ipilimumab

The main purpose of this study is to look at the effectiveness, safety, and anti-tumor activity (preventing growth of the tumor) of the drugs Niraparib with either Ipilimumab or Nivolumab on patients and their pancreatic cancer.

Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy

PARPVAX: Parpvax: A Phase 1b/2, Open Label Study of Niraparib Plus Either Ipilimumab or Nivolumab in Patients With Advanced Pancreatic Cancer Whose Disease Has Not Progressed on Platinum-based Therapy

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.

The incidence of adverse events (AEs), clinical laboratory abnormalities and dose modifications.

Identification of HRDs and allele specific LOH via whole exome sequencing

Assessed using immune biomarkers, and RNAseq of PBMC

Measured by CT scans and other studies (MRI, X-ray, PET, and ultrasound)

start of treatment to death due to any cause or last patient contact alive

Bristol-Myers Squibb

GlaxoSmithKline

University of Pennsylvania

Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle.

Nivolumab 480mg IV day 1 of each cycle.

Niraparib + Nivolumab (Arm A)

Niraparib + Ipilimumab: 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.

Niraparib + Ipilimumab (Arm B)

Niraparib + Nivolumab

Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle.

Nivolumab 480mg IV day 1 of each cycle.

Arm A

Niraparib + Ipilimumab

Niraparib + Ipilimumab: 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.

Arm B

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Regulatory Lead

The efficacy population will consist of all patients who received at least one dose of study treatment and had a least one post-treatment assessment of response by RECIST v.1.1.

Spots Global Cancer Trial Database for niraparib + nivolumab