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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

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 more

Awards & 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

Synthetic Tumor-Associated Peptide Vaccine Therapy (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02600949 — Phase 1
Pancreatic Cancer Research Study Groups: Cohort C and D (vaccine, imiquimod, pembrolizumab, APX005M), Cohort A (personalized vaccine, imiquimod), Cohort B (personalized vaccine, imiquimod, pembrolizumab)
Pancreatic Cancer Clinical Trial 2023: Synthetic Tumor-Associated Peptide Vaccine Therapy Highlights & Side Effects. Trial Name: NCT02600949 — Phase 1
Synthetic Tumor-Associated Peptide Vaccine Therapy (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02600949 — Phase 1
~10 spots leftby May 2025