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Niraparib + Immunotherapy for Pancreatic Cancer (Parpvax Trial)
Parpvax Trial Summary
This trial is testing the effectiveness of two drugs, Niraparib and Ipilimumab or Nivolumab, on pancreatic cancer.
Parpvax Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowParpvax Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Parpvax Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Arm A
- Group 2: Arm B
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What are the goals that this clinical trial is hoping to achieve?
"The purpose of this medical trial, which will be assessed six months after treatment begins, is to observe the progression-free survival rate of patients. Additionally, researchers will monitor for secondary outcomes including duration of response, safety and tolerability of the intervention, and objective response rate."
Do we have any previous case studies to refer to involving this drug combination?
"As of right now, 890 different clinical trials are investigating the efficacy of Niraparib + Ipilimumab. Out of these, 99 are in Phase 3. The vast majority of research sites for Niraparib + Ipilimumab are located in Pittsburgh, 45883 to be precise."
How many subjects are enrolled in this clinical trial?
"Currently, this clinical trial is not admitting new participants. The original posting date was January 31st, 2018 and the most recent edit was on March 23rd, 2022. However, there are 806 other trials for adenocarcinoma and 890 Niraparib + Ipilimumab studies that are looking for patients right now."
What are the favorable effects of using Niraparib + Ipilimumab?
"Niraparib + Ipilimumab is most often used as a second line of treatment for patients that have already tried anti-angiogenic therapy. It can also be prescribed to treat conditions such as malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Are we still enrolling patients for this experiment?
"According to the latest update on clinicaltrials.gov, this particular trial is not searching for any more participants at the moment. The trial was originally posted on 1/31/2018 and last updated on 3/23/2022. There are, however, 1696 other trials currently looking for patients."
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