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Cancer Vaccine
Combination Immunotherapy for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Dung Le, M.D.
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
ECOG performance status of 0 or 1
Documented adenocarcinoma of the pancreas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will enroll patients with metastatic pancreatic cancer who have progressed on prior chemotherapy. Patients will receive a combination of epacadostat, pembrolizumab, and either cyclophosphamide/GVAX pancreas vaccine or CRS-207. The primary objectives of the study are to determine the recommended dose of epacadostat and to assess the survival of patients in both treatment groups.
Who is the study for?
This trial is for patients with metastatic pancreatic cancer who have not responded to previous chemotherapy. They must expect to live more than 3 months, be able to undergo tumor biopsies, and have a good performance status (able to carry out daily activities). Patients should not join if they have brain metastases, certain heart diseases, severe infections or immune conditions, recent surgeries or vaccinations, are pregnant/breastfeeding, or cannot follow the study protocol.Check my eligibility
What is being tested?
The trial tests combinations of epacadostat/pembrolizumab with CY/GVAX pancreas vaccine and CRS-207 in different phases. The goal is to find the best dose of epacadostat when used with these drugs and vaccines and see how well patients do on these treatments compared to others.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in organs like lungs (pneumonitis), infusion-related reactions from drug administration into the bloodstream, fatigue, blood disorders that can affect clotting or immunity levels leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I have been diagnosed with pancreatic cancer.
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I agree to have two tumor biopsies taken.
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
6 Month Survival
Recommended Dose of Epacadostat
Secondary outcome measures
Number of participants experiencing drug-related adverse events (AEs) requiring treatment discontinuation
Trial Design
2Treatment groups
Experimental Treatment
Group I: Epacadostat/Pembrolizumab/CY/GVAX/CRS-207Experimental Treatment5 Interventions
Group II: Epacadostat/Pembrolizumab/CRS-207Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epacadostat
2018
Completed Phase 3
~1080
Pembrolizumab
2017
Completed Phase 2
~2010
CRS-207
2015
Completed Phase 2
~550
CY
2015
Completed Phase 2
~140
GVAX
2015
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,860 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,531 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a condition called Serotonin Syndrome in the past.I am fully active or can carry out light work.I have previously been treated with specific immune therapies.I haven't taken steroids or immunosuppressants in the last 2 weeks.I have had lung inflammation treated with steroids, or I have a lung condition.I have a serious fluid buildup in the lining of my lungs.I am infected with HIV, hepatitis B, or hepatitis C.I use more than 2 grams of acetaminophen daily.My blood and organ tests meet the study's requirements.I have not received a live vaccine in the last 30 days, except for the flu vaccine.You are allergic to both penicillin and sulfa.I haven't had a blood clot in my lungs, legs, or liver vein in the last 2 months.I am not taking any UGT1A9 inhibitors.I am taking warfarin.You have had an abnormal electrocardiogram (ECG) that the doctor thinks is important.I have an autoimmune disease, but it's not Graves, Hashimoto's, vitiligo, or type I diabetes.I need extra oxygen or my oxygen levels are low without it.You are expected to live for at least 3 more months.My pancreatic cancer worsened after chemotherapy.My cancer has spread to my brain.I have serious heart disease or need antibiotics to prevent heart infection.I haven't had surgery within the last 28 days, except for minor procedures.I am allergic to some medications, including monoclonal antibodies.You have alcohol or drug problems, other illnesses, or difficulty with getting blood drawn that could make it hard for you to go to study appointments and tests.I am unable to follow the study's schedule.You have at least one visible and measurable abnormality.I haven't had cancer treatment like chemo, radiation, or biological therapy in the last 14 days.I have been diagnosed with pancreatic cancer.I have not used growth factors in the last 14 days.I have fluid in my abdomen, but it might be a small amount.I agree to have two tumor biopsies taken.You have artificial joints or implants that cannot be easily taken out, or a history of infection related to an implant.My cancer is growing quickly.I haven't taken MAOI drugs or similar in the last 21 days.I have a stomach or intestine condition that could affect how medicines work for me.
Research Study Groups:
This trial has the following groups:- Group 1: Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
- Group 2: Epacadostat/Pembrolizumab/CRS-207
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.
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
What portion of applicants met pre-screening criteria?
Met criteria
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