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Cancer Vaccine
Personalized Cancer Vaccine for Pancreatic and Colorectal Cancer
Phase 1
Recruiting
Led By Michael J Overman
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Calculated creatinine clearance >= 40 mL/min/1.73 m^2
Must not have
Has a known additional malignancy that is progressing or requires active treatment
JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): Women of child bearing potential who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a personalized vaccine made from a patient's own tumor cells to see if it is safe and effective at treating advanced pancreatic or colorectal cancer.
Who is the study for?
This trial is for adults with advanced pancreatic or colorectal cancer who have a life expectancy of more than 6 months and can provide tumor tissue. They must have had at least one line of standard chemotherapy, be able to use birth control, and not be pregnant or breastfeeding. Specific criteria apply for different cohorts within the study.
What is being tested?
The trial is testing a personalized peptide vaccine made from patients' own tumor cells and blood, alongside other treatments like Pembrolizumab and Sotigalimab. It aims to see how well these work as biological therapies against advanced cancers that are hard to treat.
What are the potential side effects?
Potential side effects may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue, allergic responses, as well as any specific side effects related to Pembrolizumab and Sotigalimab which could range from immune-related issues to digestive disturbances.
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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My kidneys are functioning well enough to filter waste.
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I am mostly active and can care for myself.
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I am very active or able to carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have another cancer that is getting worse or needs treatment.
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I am not pregnant or breastfeeding.
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I am not pregnant or breastfeeding.
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I have had lung inflammation treated with steroids, or I have a lung condition.
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I have an active tuberculosis infection.
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I am HIV positive and not on antiretroviral therapy.
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I do not have any severe illnesses that would stop me from following the study's requirements.
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I do not have brain metastases.
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I do not have any uncontrolled illnesses that could interfere with the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events (AEs)
Secondary study objectives
Change in neoantigen-specific T cell response (cohort C and D)
Levels of intracellular cytokine staining of T cells
Overall survival
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C and D (vaccine, imiquimod, pembrolizumab, APX005M)Experimental Treatment6 Interventions
Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 9, 12, 15, 18, 21, and 24. Beginning 15 minutes after each vaccine is administered, patients receive imiquimod cream topically. Patients also receive pembrolizumab IV over 30 minutes every 3 weeks until week 24 in the absence of disease progression or unacceptable toxicity. Beginning about 1 hour after each vaccine, patients also receive sotigalimab IV over 60 minutes on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and weeks 6,12, and 24, then every 3 months, and at week 39.
Group II: Cohort B (personalized vaccine, imiquimod, pembrolizumab)Experimental Treatment5 Interventions
Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24. Beginning 15 minutes after each vaccine is administered, patients receive imiquimod cream topically. Patients also receive pembrolizumab IV over 30 minutes every 3 weeks until week 24 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and at weeks 0 and 6, then every 3 months, and at week 39.
Group III: Cohort A (personalized vaccine, imiquimod)Experimental Treatment4 Interventions
Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24. Beginning 15 minutes after each vaccine is administered, patients then receive imiquimod cream topically in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and at weeks 0 and 6, then every 3 months, and at week 39.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imiquimod
2005
Completed Phase 4
~2010
Pembrolizumab
2017
Completed Phase 3
~2810
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,059 Previous Clinical Trials
1,800,518 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,016,649 Total Patients Enrolled
Michael J OvermanPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
170 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer that is getting worse or needs treatment.I haven't had chemotherapy or radiotherapy in the last 2 weeks and have recovered from any side effects.I am not pregnant or breastfeeding.I have not had severe heart failure or a heart attack in the last 6 months.I have an autoimmune disease but it's under control or not expected to worsen.I am not on high-dose steroids or immunosuppressants, except for inhaled/topical steroids or low-dose prednisone.I have not had a blood clot in an artery in the last 3 months.I have metastatic colorectal cancer and have had or will have surgery to remove the cancer spread.I am not pregnant or breastfeeding.I have had lung inflammation treated with steroids, or I have a lung condition.I have an active tuberculosis infection.You are allergic to the vaccine, pembrolizumab, imiquimod, or APX005M or any of their ingredients.I have finished all my planned additional cancer treatments.I am HIV positive and not on antiretroviral therapy.I do not have any severe illnesses that would stop me from following the study's requirements.Before my first vaccine dose, my cancer was either measurable or marked by high tumor levels.My blood test shows cancer DNA after surgery or at any point if the first test was negative or failed.My CA19-9 levels are high, indicating cancer presence.I haven't had a live vaccine within 30 days before starting the study, except for inactivated flu or COVID-19 shots.I have metastatic pancreatic cancer or colorectal cancer.I have or will have a tumor sample available for testing.I agree to use birth control during and for 120 days after the study unless I or my partner is surgically sterile.I can join before tissue collection but will get the vaccine after at least one standard chemotherapy.My liver function tests are within the acceptable range.I have pancreatic cancer and am scheduled for a surgery aiming for complete tumor removal.I agree to a blood test within 6 weeks after surgery to check for cancer signs.I do not have brain metastases.I am 18 years old or older.You have enough white blood cells called neutrophils in your body.You are expected to live for at least 6 months (12 months for cohort C and 9 months for cohort D).I agree to a blood test for cancer DNA within 6 weeks after surgery.My kidneys are functioning well enough to filter waste.Your platelet count is at least 75,000 per microliter.Your total bilirubin level should be less than or equal to twice the normal limit at the hospital.You have a current blood clotting problem.I am mostly active and can care for myself.My radiographic disease status does not affect my eligibility for treatment in cohorts C and D.I do not have any uncontrolled illnesses that could interfere with the study.I am very active or able to carry out light work.You have a history of hepatitis B or active hepatitis C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort C and D (vaccine, imiquimod, pembrolizumab, APX005M)
- Group 2: Cohort A (personalized vaccine, imiquimod)
- Group 3: Cohort B (personalized vaccine, imiquimod, 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.
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