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Checkpoint Inhibitor
Niraparib + Immunotherapy for Pancreatic Cancer (Parpvax Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology (ECOG) performance status of 0 to 1.
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with locally advanced or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first restaging assessment until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first
Awards & highlights
Parpvax Trial Summary
This trial is testing the effectiveness of two drugs, Niraparib and Ipilimumab or Nivolumab, on pancreatic cancer.
Who is the study for?
Adults with pancreatic adenocarcinoma that hasn't worsened after at least 16 weeks of platinum-based chemotherapy can join. They must have good organ function, not be pregnant or fathering a child, and agree to use contraception. Exclusions include resistance to platinum drugs, autoimmune diseases, recent vaccines or treatments for cancer, certain blood disorders from past chemo, active infections or other conditions that could affect the trial.Check my eligibility
What is being tested?
The study tests Niraparib combined with either Ipilimumab or Nivolumab in patients whose pancreatic cancer didn't progress after initial chemotherapy. It aims to assess how safe and effective these drug combinations are in stopping tumor growth.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, immune system-related issues due to Ipilimumab or Nivolumab (like inflammation), digestive problems from Niraparib absorption issues, and typical chemotherapy-associated risks like fatigue and blood cell count changes.
Parpvax Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my daily activities without help.
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My pancreatic cancer is confirmed and has spread.
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I am 18 years old or older.
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My kidney function is within the required range.
Parpvax Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first restaging assessment until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first restaging assessment until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Progression-free Survival at 6 Months (PFS6)
Secondary outcome measures
Correlation of HRDs With Response to Treatment With Niraparib Plus Immune Checkpoint Blockade
Duration of Response (DOR)
Immune Activation During Treatment
+5 moreParpvax Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Niraparib + Ipilimumab
Group II: Arm AExperimental Treatment1 Intervention
Niraparib + Nivolumab
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,019 Previous Clinical Trials
42,874,042 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,768 Previous Clinical Trials
8,105,633 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,732 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had myelodysplastic syndrome or acute myeloid leukemia.You can still participate if you have vitiligo, type I diabetes, mild hypothyroidism that is managed with hormone replacement, psoriasis that does not require strong medication, or conditions that are not likely to come back without a specific cause.I can carry out all my daily activities without help.I do not have HIV/AIDS.My pancreatic cancer is confirmed and has spread.My cancer has not responded to treatments like cisplatin or oxaliplatin.I have a history of lung scarring or inflammation not caused by an infection.I have or haven't had cancer treatment without platinum that didn't work.I do not need to have measurable disease to join the study.I am 18 years old or older.I responded to platinum therapy without disease progression for 16 weeks but stopped early for health reasons.I do not have any stomach or bowel problems that affect how I absorb medicine.I haven't had a blood transfusion in the last 4 weeks.I am a male and agree to use contraception for 90 days after the last dose.I haven't had any pancreatic cancer treatment in the last 14 days or investigational therapy in the last 4 weeks or within 5 half-lives of the agent.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I have recovered from recent surgery and am stable enough for treatment.I haven't had radiotherapy in the last 4 weeks.I am not currently receiving treatment for an active cancer, except for skin cancer or hormone therapy for breast or prostate cancer.I've had platinum-based treatment for advanced pancreatic cancer for at least 16 weeks without the cancer getting worse.I stopped platinum-based therapy due to side effects but was on it for at least 16 weeks without my cancer getting worse.I am not pregnant and agree to avoid pregnancy during the study.My cancer has not worsened according to recent scans and tests.My recent tests show my organs are working well.I do not have any active autoimmune diseases like lupus, rheumatoid arthritis, or inflammatory bowel disease.You cannot participate if you have a known allergy or sensitivity to niraparib or any other ingredients in the medication.I agree to use birth control from the first dose until 90 days after the last dose.I do not have brain or spinal cord cancer spread that causes symptoms.I agree to use effective birth control for 6 months after my last dose.I have not needed IV antibiotics or antiviral/fungal drugs in the last 14 days.I have previously been treated with specific immune or targeted therapies.My kidney function is within the required range.I have not received a live vaccine in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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