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Alkylating agents
Multi-agent Chemotherapy + Olaparib and Pembrolizumab for Pancreatic Cancer
Phase 2
Recruiting
Led By Dung Le, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years.
Patients must not have received prior treatment for pancreatic cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat pancreatic cancer.
Who is the study for?
This trial is for adults with untreated metastatic pancreatic ductal cancer who have stable or progressive disease after chemotherapy. They must be in good physical condition, understand the study, and agree to use birth control. Excluded are those planning surgery, recent chemo or investigational drug users, with autoimmune diseases, uncontrolled illnesses, certain prior treatments or allergies to monoclonal antibodies.Check my eligibility
What is being tested?
The trial tests maintenance therapy with Olaparib and Pembrolizumab following a multi-agent low dose chemotherapy regimen (GAX-CI) consisting of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin and Irinotecan in patients who haven't been treated before for their pancreatic cancer.See study design
What are the potential side effects?
Possible side effects include nausea from chemotherapy drugs; fatigue; blood cell count changes leading to infection risk; allergic reactions; organ inflammation due to immunotherapy agents like Pembrolizumab; and potential complications from Olaparib affecting blood cells and kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have not had any treatment for pancreatic cancer.
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I am willing to undergo a tumor biopsy.
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My organ and bone marrow functions meet the required levels.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I will use an approved method of birth control during the study.
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My pancreatic cancer has spread and is confirmed by tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 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) after 6 months according to IRECIST criteria.
Progression-free Survival (PFS) after 6 months according to RECIST 1.1 criteria.
Secondary outcome measures
Number of participants experiencing grade 3 or above drug-related toxicities
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nab-paclitaxel, Gemcitabine , Cisplatin, Irinotecan, CapecitabineExperimental Treatment7 Interventions
Maintenance of Pembrolizumab and Olaparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Olaparib
2007
Completed Phase 4
~2140
Capecitabine
2013
Completed Phase 3
~3420
Nab-paclitaxel
2014
Completed Phase 3
~2030
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Irinotecan
2017
Completed Phase 4
~2680
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,060,057 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,882 Total Patients Enrolled
Dung Le, MDPrincipal InvestigatorSKCCC Johns Hopkins Medical Institution
12 Previous Clinical Trials
596 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am willing to undergo a tumor biopsy.My cancer has worsened despite treatment before completing 6 cycles of GAX-CI.I have not had any treatment for pancreatic cancer.My disease has not worsened after 6 treatments with GAX-CI.I am not pregnant and will follow the study's birth control requirements.I am currently taking medication that strongly affects liver enzymes.My organ and bone marrow functions meet the required levels.I haven't had any live vaccines, allergy treatments, growth factors, or major surgery in the last 30 days.You have a disease that can be measured using specific medical guidelines.You have had a bad reaction to any kind of monoclonal antibody.I am fully active or restricted in physically strenuous activity but can do light work.I will use an approved method of birth control during the study.I have been treated with specific cancer drugs like gemcitabine or cisplatin.I have another cancer that is getting worse and needs treatment.My pancreatic cancer has spread and is confirmed by tests.I have had radiation therapy for pancreatic cancer.I have had a transplant of tissue, organ, or bone marrow from another person.I need daily oxygen support.I understand the study, its risks, and how to manage side effects.I need treatment to stop my cancer from growing.I am HIV positive.I have an infection that is not responding to treatment.I have a serious wound.I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.I am not being considered for surgery.I have had chemotherapy in the last 5 years.I have a serious illness that is not under control.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.You have a current autoimmune disease that is not under control.I have had lung inflammation that needed steroids.I have an autoimmune disease or have been on steroids recently.I am not pregnant or breastfeeding.I had surgery less than 28 days before starting the trial medication.I have had cancer spread to my brain or spinal cord.I have active Hepatitis B or C, or I am Hepatitis C antibody positive but viral load negative.
Research Study Groups:
This trial has the following groups:- Group 1: Nab-paclitaxel, Gemcitabine , Cisplatin, Irinotecan, Capecitabine
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.
Has Olaparib been investigated by researchers in the past?
"Presently, Olaparib is the subject of 2843 clinical trials with 663 in their final phase. While Guangzhou, Guangdong hosts most of these experiments, there are 120745 locations worldwide testing this medication."
Answered by AI
Are research participants still being sought for this investigation?
"According to the clinicaltrials.gov website, this medical trial is still open for recruitment and has been since its initial posting on September 29th 2021. It was last modified in March 14th 2022."
Answered by AI
Has the FDA sanctioned Olaparib yet?
"Our internal analysis of Olaparib gives it a safety rating of 2 due to the Phase 2 trial design, where some evidence for safety is present but none exists for efficacy."
Answered by AI
In what ways is Olaparib typically employed to benefit patients?
"Olaparib is typically administered to treat malignant melanoma of skin; however, it can also provide relief from recurrent cervical cancer, refractory relapsed mediastinal large b-cell lymphoma and metastatic bladder cancer."
Answered by AI
What is the size of the cohort participating in this research endeavor?
"Indeed, the publically accessible clinicaltrials.gov records demonstrate that this research project has been actively recruiting since September 29th 2021 and is seeking 38 individuals from two sites. The protocol was last updated on March 14th 2022."
Answered by AI
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