Niraparib + Ipilimumab Or Nivolumab In Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-12-19	Results First Submitted 2023-05-09	Last Update Submitted that met QC Criteria 2025-05-13
First Submitted that Met QC Criteria 2018-01-12	Results First Submitted that Met QC Criteria 2023-06-12	Last Update Posted (ACTUAL) 2025-05-14
First Posted (ACTUAL) 2018-01-19	Results First Posted 2023-07-03	Last Verified 2025-05

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm A Niraparib + Nivolumab	DRUG: Niraparib + Nivolumab Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.
EXPERIMENTAL: Arm B Niraparib + Ipilimumab	DRUG: 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm A

Niraparib + Nivolumab

DRUG: Niraparib + Nivolumab

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

EXPERIMENTAL: Arm B

Niraparib + Ipilimumab

DRUG: 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.

Primary Outcome Measures	Measure Description	Time Frame
Rate of Progression-free Survival at 6 Months (PFS6)	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.	6 months after initiation of study therapy

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rate (ORR) Per RECIST v.1.1 as Assessed by Radiology Review	The proportion of patients who achieve a complete or partial response, as determined by RECIST	From first restaging assessment through completion of study treatment (maximum 42 months)
Overall Survival (OS)	Start of treatment to death due to any cause or last patient contact alive.	Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

This requires at least stable imaging and a stable or decreasing tumor marker as applicable and as determined by the investigator.
If a patient has demonstrated a biochemical and imaging response to platinum therapy and has not progressed within 16 weeks of starting this therapy but had to discontinue platinum prior to 16 weeks for a legitimate medical reason (as determined by the investigator), the patient may still be considered for the trial 5. Patients may have previously failed non-platinum containing therapy or may never have previously progressed on treatment

Discontinuation of the platinum component of the regimen for chemotherapy-related toxicity is permissible provided the patient has previously received at least 16 weeks of platinum-based therapy without evidence of disease progression ≤8 weeks after treatment with the platinum agent 6. Measurable disease is not a requirement for study entry 7. Female participant has a negative serum pregnancy test within 24 hours prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 6 months after the last dose of study treatment, or is of nonchildbearing potential 8. Male patient agrees to use an adequate method of contraception starting with the first dose through 90 days after the last dose of study treatment 9. Adequate organ function confirmed by the following laboratory values obtained ≤7 days prior to the first day of study therapy:

Absolute neutrophil count (ANC) ≥1.5 x 109/L
Platelets>100 x 109/L
Hemoglobin ≥9g/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN); if liver metastases, then ≤5 x ULN
Total bilirubin ≤1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert's syndrome, then ≤2.5 x ULN.
Serum creatinine ≤1.5 x ULN or estimated glomerular filtration rate (GFR) ≥45 mL/min using Cockcroft Gault formula. 10. Eastern Cooperative Oncology (ECOG) performance status of 0 to 1.

Female patients refusing to use effective contraception for 6 months after the last dose of study drug.
Male patients refusing to use effective contraception for 90 days after the last dose of study drug. 9. Received any systemic treatment for pancreatic cancer ≤14 days prior to first dose of therapy. Patients must not have had investigational therapy administered ≤4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study 10. Patients will be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 11. Patient has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment. 12. Non-study related minor surgical procedure ≤5 days, or major surgical procedure ≤21 days, prior to the first dose of therapy; in all cases, patients must be sufficiently recovered and stable before treatment administration. 13. Active drug or alcohol use or dependence that would interfere with study compliance. 14. Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study. 15. Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) 16. Patients must not be simultaneously enrolled in any therapeutic clinical trial 17. Patients must not have had radiotherapy within 4 weeks of the first dose of study treatment 18. Patients must not have a known hypersensitivity to the components of niraparib or the excipients 19. Patients must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks of the first dose of study treatment 20. Patients must not be undergoing treatment for an active cancer at the time of randomization. Exceptions include: local therapies for skin cancers and hormonal therapies for breast or prostate cancer. 21. Patients must not have a history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), and must not test positive for HIV during study screening. 22. Patients must not have known, symptomatic brain or leptomeningeal metastases

Collaborators and Investigators

Publications

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Caregivers

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