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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

Must not have

Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)

Patients who have demonstrated resistance to platinum agents (e.g. oxaliplatin, cisplatin) are not eligible to participate in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first restaging assessment through completion of study treatment (maximum 42 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had myelodysplastic syndrome or acute myeloid leukemia.

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My cancer has not responded to treatments like cisplatin or oxaliplatin.

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I have a history of lung scarring or inflammation not caused by an infection.

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I am a male and agree to use contraception for 90 days after the last dose.

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I haven't had radiotherapy in the last 4 weeks.

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I do not have HIV/AIDS.

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I do not have any active autoimmune diseases like lupus, rheumatoid arthritis, or inflammatory bowel disease.

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I do not have brain or spinal cord cancer spread that causes symptoms.

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I have not needed IV antibiotics or antiviral/fungal drugs in the last 14 days.

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I have previously been treated with specific immune or targeted therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first restaging assessment through completion of study treatment (maximum 42 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first restaging assessment through completion of study treatment (maximum 42 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first restaging assessment through completion of study treatment (maximum 42 months) for reporting.