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Alkylating agents
Combination Therapy for Pancreatic Cancer
Phase < 1
Waitlist Available
Led By Ana DeJesus, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will be testing a new combination therapy for pancreatic cancer.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CD8 T cell density in the primary tumor after neoadjuvant administration of combination immunotherapy by immunohistochemistry (IHC)
Number of participants experiencing study drug-related toxicities
Secondary outcome measures
Disease free survival (DFS)
Objective response rate (ORR) by immune-related RECIST criteria (irRC)
Overall survival (OS)
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4Experimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMC-CS4
2018
Completed Phase 1
~90
Cyclophosphamide
1995
Completed Phase 3
~3780
Pembrolizumab
2017
Completed Phase 2
~2010
GVAX
2015
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,559 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,613 Previous Clinical Trials
3,200,917 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,888 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to use oxygen at home.You had a type of radiation treatment called stereotactic body radiotherapy within the past 28 days.You have received certain types of immunotherapy treatments in the past.You have known or suspected allergies to certain substances used in the GVAX pancreas vaccine, such as GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (from pigs), yeast, or any other ingredient.You are willing to have a small tissue sample taken for testing.You have a history of lung inflammation that needed steroids or have a current lung disease that is not caused by an infection.You currently have or have had certain medical conditions related to your heart, liver, kidney, lungs, brain, mental health, immune system, or other specific conditions mentioned in the study.You have had a strong allergic reaction to any type of monoclonal antibody in the past.You have a history of certain autoimmune diseases like inflammatory bowel disease, rheumatoid arthritis, or lupus. However, if you have thyroid disease, you can still participate.You should not have cancer that has spread to other parts of your body.
Research Study Groups:
This trial has the following groups:- Group 1: Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4
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.
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