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PARP Inhibitor
Pembrolizumab + Olaparib for Pancreatic Cancer
Phase 2
Recruiting
Led By Vincent Chung
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with neuroendocrine tumors, acinar cell and adenosquamous carcinomas are excluded. All disease must be assessed and documented on the Baseline Tumor Assessment Form
Patients must be >= 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of registration to date of first documentation of progression or symptomatic deterioration (per response evaluation criteria in solid tumors [recist] 1.1), or death due to any cause, assessed up to 3 years
Awards & highlights
Study Summary
This trial is testing whether adding pembrolizumab to olaparib, which is the standard of care, is more effective in treating patients with metastatic pancreatic cancer who have BRCA1 or BRCA2 mutations.
Who is the study for?
This trial is for adults with metastatic pancreatic cancer who have inherited BRCA mutations. They must have completed first-line platinum-based chemotherapy, show stable or responding disease, and not be on certain drugs that affect olaparib. People with HIV or hepatitis C can join if treated and virus-free. Those with a history of severe lung inflammation, active infections, autoimmune diseases needing recent treatment, or other cancers that could interfere are excluded.Check my eligibility
What is being tested?
The study is testing if adding pembrolizumab (an immunotherapy drug) to olaparib (a PARP inhibitor used as standard care) is more effective in treating patients whose pancreatic cancer has spread and have BRCA1/2 mutations. It's a phase II trial where the effectiveness of this combination will be compared to using olaparib alone.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from pembrolizumab, fatigue, nausea from both drugs; blood cell count changes; increased risk of infection; potential harm to unborn babies necessitating contraception.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with pancreatic adenocarcinoma.
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I am 18 years old or older.
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I have never been treated with immune checkpoint inhibitors.
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I have never needed steroids for non-infectious lung inflammation.
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I have metastatic disease and have received first line platinum-based chemotherapy.
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I do not have an infection that needs treatment with medication.
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I have not been diagnosed with immunodeficiency or taken high-dose steroids or immunosuppressants in the last week.
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I can carry out all my usual activities without help.
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I have a hereditary BRCA 1 or 2 mutation confirmed by a certified lab.
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I have never been treated with PARP inhibitors.
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I can swallow pills and don't have stomach issues affecting medicine absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of registration to date of first documentation of progression or symptomatic deterioration (per response evaluation criteria in solid tumors [recist] 1.1), or death due to any cause, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to date of first documentation of progression or symptomatic deterioration (per response evaluation criteria in solid tumors [recist] 1.1), or death due to any cause, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Duration of response (DoR)
Incidence of adverse events
Overall response rate (ORR) per RECIST 1.1
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (olaparib, pembrolizumab)Experimental Treatment6 Interventions
Patients receive olaparib PO BID on days 1-21 and pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 19, patients receive olaparib PO BID on days 1-42 and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI, tumor biopsy and blood sample collection throughout the study.
Group II: Arm B (olaparib)Active Control5 Interventions
Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI, tumor biopsy and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Olaparib
2007
Completed Phase 4
~2140
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,667 Previous Clinical Trials
40,926,044 Total Patients Enrolled
Vincent ChungPrincipal InvestigatorSWOG Cancer Research Network
9 Previous Clinical Trials
321 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.Your immune system's white blood cell count is at least 1.5 x 10^3 per microliter of blood.I understand this study is experimental and I (or my legal representative) have signed the consent form.I have never been treated with immune checkpoint inhibitors.My side effects from previous cancer treatments are mild or gone, except for nerve issues or hair loss.I have HIV, am on effective treatment, and my last viral load was undetectable.Your kidney function, measured with a test called creatinine clearance, needs to be higher than 50 mg/dL within 14 days of signing up for the study.I have never needed steroids for non-infectious lung inflammation.I haven't needed treatment for an autoimmune disease in the last 2 years.My recent scans show my cancer is stable or improving after first round of platinum-based chemotherapy.I have metastatic disease and have received first line platinum-based chemotherapy.I have another cancer type, but it won't affect this trial's treatment.Your hemoglobin level should be at least 9.0 grams per deciliter within 14 days before joining the study.I do not have an infection that needs treatment with medication.I have not been diagnosed with immunodeficiency or taken high-dose steroids or immunosuppressants in the last week.I agree to provide tissue samples for research if needed.I've had at least 16 weeks of initial chemotherapy for my advanced cancer, possibly with a short treatment of gemcitabine + nab-paclitaxel.I haven't had any live vaccines in the last 42 days and won't get any during the study.Your AST and ALT levels are not more than three times the normal limit at the time of registration.My kidney function, measured by creatinine or clearance, is within the normal range.I have been diagnosed with pancreatic adenocarcinoma.I am not pregnant or nursing and will use effective birth control during the study.My last chemotherapy was less than 30 days ago.I can carry out all my usual activities without help.I had hepatitis C but am cured, or if currently treated, I have no detectable virus now.I have a hereditary BRCA 1 or 2 mutation confirmed by a certified lab.Your platelet count is at least 100,000 per microliter within 14 days of enrolling in the study.I've had a full medical check-up in the last 28 days.You need to have a CA19-9 test done within 42 days before joining the trial.I have never been treated with PARP inhibitors.Your total bilirubin level must be within a certain range, as determined by the hospital's standard.Your albumin level in your blood should be at least 3.0 grams per deciliter within 14 days before joining the study.I have another cancer that won't affect this trial's treatment.I can swallow pills and don't have stomach issues affecting medicine absorption.My hepatitis B virus load is undetectable as of the last 30 days.I am not taking, nor plan to take, certain medications that affect how drugs work in my body while on olaparib.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (olaparib)
- Group 2: Arm A (olaparib, pembrolizumab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor actively recruiting participants?
"Indeed, clinicaltrials.gov confirms that recruitment for this medical investigation is ongoing. The trial was first publicized on December 4th 2020 and its most recent update occurred on November 30th 2022; 88 patients must be enrolled from 100 different sites."
Answered by AI
Are there any prior experiments utilizing Pembrolizumab?
"Presently, there are 1114 active trials researching the efficacy of Pembrolizumab. Of these studies, 143 have advanced to Phase 3 and 42748 locations around the globe are conducting them. Houston is one such city that is hosting a large number of these experiments."
Answered by AI
Is there anything unique about this research project?
"As of today, Pembrolizumab is the subject of 1114 active trials that span across 3058 cities and 66 countries. This drug's clinical journey began in 2005 when AstraZeneca sponsored a Phase 1 trial involving 98 patients; since then, 314 more studies have been concluded."
Answered by AI
What hazards have been identified when using Pembrolizumab?
"As this is Phase 2 trial, there has been some evidence suggesting safety and no proof of efficacy. Consequently, Pembrolizumab receives a rating of 2 on our team's risk scale."
Answered by AI
Are there any Canadian locations participating in the experiment?
"This research trial is now being conducted in over 100 different sites, including Mechanicsville, Columbus and Littleton. To reduce the burden of travel on participants, we recommend that you select a location closest to where you live."
Answered by AI
How many participants are receiving treatment in this clinical research study?
"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, first posted on December 4th 2020, is actively seeking participants. The research aims to recruit 88 patients from 100 different sites."
Answered by AI
What maladies has Pembrolizumab been proven to alleviate?
"Pembrolizumab is a common medication for unresectable melanoma, but can also be prescribed to patients with microsatellite instability high, elevated risk of relapse, and the presence of disease."
Answered by AI
Who else is applying?
What state do they live in?
California
New York
How old are they?
18 - 65
What site did they apply to?
Alta Bates Summit Medical Center-Herrick Campus
Palo Alto Medical Foundation-Fremont
Sanford Cancer Center Oncology Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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