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

Study acronym: ParpVax2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 50 words Secondary endpoints: details revised at 1 of 7 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 7 entries
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 9, 2025 to May 7, 2025 · Site details revised at 2 of 2 sitesv6 Show 2 more changesShow less
    • Start date changed from estimate of May 9, 2025 to May 7, 2025
    • Site details revised at 2 of 2 sites
  4. Start date: Apr 30, 2025 to May 9, 2025 Site contacts updated at 1 of 2 sitesv5 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Mar 31, 2025 to Apr 30, 2025v3
  2. Start date: Jan 6, 2025 to Mar 31, 2025 Site contacts updated at 2 of 2 sitesv2 Show 1 more changeShow less
    • Site contacts updated at 2 of 2 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06747845
Lead Sponsor Abramson Cancer Center at Penn Medicine
Collaborators: Lustgarten Foundation, GlaxoSmithKline, Bristol-Myers Squibb
Conditions Pancreatic Adenocarcinoma Metastatic
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov