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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy

ParpVax2: A Phase II Study Of Maintenance Niraparib Plus Ipilimumab In Patients With Metastatic Pancreatic Cancer Whose Disease Has Not Progressed On Platinum-Based Therapy

Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy (NCT06747845) is a Phase 2 interventional studying Pancreatic Adenocarcinoma Metastatic, sponsored by Abramson Cancer Center at Penn Medicine. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The main goal of this study is to look at the effectiveness and anti-tumor activity (preventing growth of the tumor) of the drugs niraparib and ipilimumab, on the patients and their pancreatic cancer. This study will involve two different treatment arms. In Arm A, patients will receive niraparib plus ipilimumab. In Arm B, patients will receive standard chemotherapy. The main questions the study aims to answer are: * Does niraparib plus ipilimumab slow down tumor growth in patients with pancreatic cancer? * What medical problems do participants have when taking niraparib plus ipilimumab? Participants will: * Undergo screening procedures to evaluate their cancer, overall health, and suitability for the study * After passing screening, will be randomized to Arm A or B and be scheduled to receive niraparib plus ipilimumab (Arm A) or chemotherapy (Arm B) * Receive niraparib plus ipilimumab every 3 weeks (Arm A) * Receive chemotherapy every 2 weeks (Arm B) * Visit the clinic for regular checkups and tests

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Pancreatic Adenocarcinoma Metastatic and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 68 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pancreatic Adenocarcinoma Metastatic subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosed by tissue sample (biopsy-confirmed) diagnosis of pancreatic adenocarcinoma with metastatic disease - ≥18 years of age - Patients must be able to understand the study procedures and agree to participate in the study by providing written willing to sign a consent form - Participants must have received 8-12 cycles (4-6 months) of first-line FOLFIRINOX or modified FOLFIRINOX for metastatic disease with stable disease or better. Patients treated with liposomal irinotecan with oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) are also eligible. Patients who were initially treated with FOLFIRINOX or NALIRIFOX but stopped oxaliplatin because of toxicity are eligible for the trial. - Note: This requires at least stable imaging and a stable or decreasing tumor marker as applicable and as determined by the investigator. - Measurable disease is not a requirement for study entry. - Note: The study will require that at least 80% of enrolled patients (ie 55 of all patients) are biopsiable at enrollment. The investigators may require measurable/biopsiable disease as the study progresses in order to achieve this goal. - Participants must be willing to undergo a pre-treatment fresh tumor biopsy (if medically feasible). - Participants must be willing to undergo an on-treatment tumor biopsy (if medically feasible). - 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 (females) or 30 days (males) after the last dose of study treatment, or is of nonchildbearing potential. - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease * ≥18 years of age * Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent * Participants must have received 8-12 cycles (4-6 months) of first-line FOLFIRINOX or modified FOLFIRINOX for metastatic disease with stable disease or better. Patients treated with liposomal irinotecan with oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) are also eligible. Patients who were initially treated with FOLFIRINOX or NALIRIFOX but stopped oxaliplatin because of toxicity are eligible for the trial. * Note: This requires at least stable imaging and a stable or decreasing tumor marker as applicable and as determined by the investigator. * Measurable disease is not a requirement for study entry. * Note: The study will require that at least 80% of enrolled patients (ie 55 of all patients) are biopsiable at enrollment. The investigators may require measurable/biopsiable disease as the study progresses in order to achieve this goal. * Participants must be willing to undergo a pre-treatment fresh tumor biopsy (if medically feasible). * Participants must be willing to undergo an on-treatment tumor biopsy (if medically feasible). * 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 (females) or 30 days (males) after the last dose of study treatment, or is of nonchildbearing potential. * 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. * 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) ≤2.5 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. * Eastern Cooperative Oncology (ECOG) performance status of 0 to 1. Exclusion Criteria: * Prior treatment with a PARP inhibitor, ipilimumab, or other cytotoxic T-lymphocyte-associated-4 protein (CTLA-4) inhibitor. * Patients who have demonstrated resistance to FOLFIRINOX are not eligible to participate in this study * Patients with known pathogenic/likely pathogenic germline or somatic alteration(s) in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D. * Patients with known mismatch repair deficiency or microsatellite instability-high cancer. * Clinical evidence of uncontrolled malabsorption and/or any other gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with the absorption of niraparib * Patients with uncontrolled hypertension, defined as systolic BP \>140mmHg and/or diastolic BP \>90mmHg * Patients with a prior history of posterior reversible encephalopathy syndrome (PRES) * Acute infection requiring intravenous antibiotics, intravenous antiviral or intravenous antifungal agents during the 14 days prior to first dose of study therapy * Patients will be excluded if they have a history of or active autoimmune disease, defined as: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic autoimmune disease (e.g. rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis e.g. Wegener's Granulomatosis); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome). * Note: Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. * Has a history of interstitial lung disease or active, non-infectious pneumonitis * Has received a live vaccine within 4 weeks prior to the first dose of trial therapy * Note: seasonal influenza vaccines for injection are generally inactivated and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed. * For fertile patient (female able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial and: * 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. * 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. * 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. * 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. * 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. * Active drug or alcohol use or dependence that would interfere with study compliance. * 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. * Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). * Patients must not be simultaneously enrolled in any therapeutic clinical trial * Patients must not have had radiotherapy within 4 weeks of the first dose of study treatment * Patients must not have a known hypersensitivity to the components of niraparib or the excipients * Patients must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks of the first dose of study treatment * Patients must not be undergoing treatment for a second active cancer at the time of randomization. Exceptions include: (1) local therapies for skin cancers, (2) hormonal therapies for breast or prostate cancer without evidence of active disease. Patients may have a history of: (1) adequately treated nonmelanoma skin cancers, (2) curatively treated in situ cancer of the cervix, (3) curatively treated DCIS, (4) curatively treated stage I, grade 1 endometrial carcinoma, (5) other solid tumors and lymphomas (without bone marrow involvement) diagnosed at least five years prior to randomization and treated with no evidence of disease recurrence. * Patients with active hepatitis B or hepatitis C infections, as defined by positive PCR testing, may not enroll. * Patients with HIV may enroll, but must have an undetectable viral load at the time of enrollment and must be receiving a stable regimen of HAART. * Patients must not have known, symptomatic brain or leptomeningeal metastases.

Treatments Being Tested

DRUG

Niraparib

Niraparib 200mg PO daily on days 1-21 of each 21-day cycle.

DRUG

FOLFIRI

Standard chemotherapy FOLFIRI (5-fluorouracil, folinic acid, and irinotecan) will be administered intravenously every 14 days of a 28-day cycle.

DRUG

Ipilimumab

Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06747845), the sponsor (Abramson Cancer Center at Penn Medicine), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06747845 clinical trial studying?

The main goal of this study is to look at the effectiveness and anti-tumor activity (preventing growth of the tumor) of the drugs niraparib and ipilimumab, on the patients and their pancreatic cancer. This study will involve two different treatment arms. In Arm A, patients will receive niraparib plus ipilimumab. In Arm B, patients will receive standard chemotherapy. The main questions the study aims to answer are: * Does niraparib plus ipilimumab slow down tumor growth in patients with pancreatic cancer? * What medical problems do participants have when taking niraparib plus ipilimumab? Par… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06747845?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06747845?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06747845. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06747845. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.