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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Proportion of enrolled patients for whom a personalized vaccine is developed and ready to administer (cohorts A and B)
Proportion of enrolled patients who receive at least 1 dose of vaccine at any time post-enrollment (cohorts A and B)
Secondary outcome measures
Change in neoantigen-specific T cell response (cohort C and D)
Change in tumor biomarker (CA19-9, carcinoembryonic antigen [CEA] or circulating free deoxyribonucleic acid [cfDNA] mutation)
Correlation of T-cell activation against vaccinated peptides and ctDNA dynamics (cohort C and D)
+9 moreTrial 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
Pembrolizumab
2017
Completed Phase 2
~2010
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Imiquimod
2005
Completed Phase 4
~2260
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,167 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,184 Total Patients Enrolled
Michael J OvermanPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
168 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently open to subject enrollment?
"Affirmative. The information on clinicaltrials.gov demonstrates that this experiment is still seeking participants, which was first announced in May 2016 and has recently been refreshed in August 2022. One medical centre must enrol 150 individuals for the trial to be completed successfully."
Answered by AI
Has the Synthetic Tumor-Associated Peptide Vaccine Therapy attained regulatory approval?
"There is limited data supporting the safety and efficacy of Synthetic Tumor-Associated Peptide Vaccine Therapy, thus it scored a 1 on our power team's scale."
Answered by AI
To what ailments is Synthetic Tumor-Associated Peptide Vaccine Therapy commonly administered?
"Synthetic Tumor-Associated Peptide Vaccine Therapy is the primary approach for treating unresectable melanoma. Additionally, this therapeutic intervention has been demonstrated to be beneficial in managing microsatellite instability high, reducing risk of recurrence and palliating symptoms associated with illness."
Answered by AI
What is the total size of the cohort for this research endeavor?
"Affirmative. Per the records hosted on clinicaltrials.gov, this medical trial is actively seeking participants with a target enrolment of 150 patients at one site. The study was first posted in May 2016 and was recently revised in August 2022."
Answered by AI
Could you provide further information regarding the efficacy of Synthetic Tumor-Associated Peptide Vaccine Therapy in prior experiments?
"Currently, 979 clinical trials are researching Synthetic Tumor-Associated Peptide Vaccine Therapy; out of these studies, 127 have progressed to the third phase. Although Nashville is a major hub for this therapy's research, there are over 35 thousand sites conducting related experiments worldwide."
Answered by AI
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