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Personalized Peptide Vaccine for Advanced Pancreatic or Colorectal Cancer

This study is testing a personalized peptide vaccine in patients with advanced pancreatic or colorectal cancer that has spread. The vaccine is made from your own tumor cells and blood to help your body fight the cancer. Researchers want to see if this vaccine, along with other treatments like imiquimod (a topical drug), pembrolizumab (an IV biological therapy), and sotigalimab (another IV biological therapy), is safe and effective. They will also check if a personalized vaccine can be successfully created for you. This trial is for adults aged 18 and older who have metastatic colorectal or pancreatic cancer and meet other health criteria. The study aims to enroll 300 participants, but its current status is unclear.

Study design
This is an interventional study with an unspecified phase, planning to enroll 300 participants. Patients are assigned to different groups (cohorts) to receive various combinations of treatments.
What's involved
You would undergo procedures like Computed Tomography (CT) scans. You may receive personalized synthetic tumor-associated peptide vaccine therapy subcutaneously, and imiquimod cream topically, for up to 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study measures adverse events for up to 24 weeks and vaccine administration for up to 44 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02600949

Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer

Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~300 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:ImiquimodPembrolizumabSotigalimabSynthetic Tumor-Associated Peptide Vaccine TherapyComputed TomographyMagnetic Resonance Imaging

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of enrolled patients for whom a personalized vaccine is developed and ready to administer (cohorts A and B)
Measured over Up to 12 weeks post-enrollment
+2 more outcomes measured

Conditions

Metastatic Colorectal Adenocarcinoma
Metastatic Pancreatic Ductal Adenocarcinoma
Stage IV Colorectal Cancer AJCC v7
Stage IV Pancreatic Cancer AJCC v6 and v7
Stage IVA Colorectal Cancer AJCC v7
Stage IVB Colorectal Cancer AJCC v7

Explore related trials

Colorectal CarcinomaPancreatic Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Michael J Overman · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Metastatic CRC or PDA planned to or have undergone complete surgical resection (metastatectomy) and also for PDA participants with localized disease planned for primary tumor resection.
Any lines (including zero) of therapy prior to tissue harvest.
Adequate tumor tissue availability
Adults (age ≥ 18)
ECOG PS 0-1
Life expectancy \>12 months for Cohort C and \>9 months for Cohort D
Adequate organ and marrow function
Ability to understand and the willingness to sign a written informed consent document.
As the effects of a peptide based vaccine, pembrolizumab or APX005M on the developing human fetus are unknown, women of child-bearing potential and men must agree to use adequate contraception at study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant, she should inform her treating physician immediately. Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), sexually active participants must use birth control during and for \>120 days after the study. Abstinence is also an acceptable form of birth control.
For Cohort C only: participants must have metastatic CRC and are planned to or have undergone complete metastecomy/ies and agree to have post-operative blood draw for ctDNA testing within 6 weeks following surgical resection.

Exclusion

History of HIV or AIDS
Patients with brain metastasis
Serious autoimmune conditions
Use of chronic immune suppressive medications.
Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Women of child bearing potential who are pregnant or breastfeeding. Women with a positive pregnancy test at enrollment or prior to administration of vaccine. .
Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
Known history of active TB (Bacillus Tuberculosis).
Hypersensitivity to therapy drugs or their components.
Has a known additional malignancy that is progressing or requires active treatment.
Active coagulopathy.
History of arterial thrombosis within 3 months prior to starting study treatment.
History of New York Heart Association Class 3-4 heart failure or myocardial infarction within 6 months prior to starting therapy.
Known history of Hepatitis B or known active Hepatitis C.

What this trial measures

  • Proportion of enrolled patients for whom a personalized vaccine is developed and ready to administer (cohorts A and B)Up to 12 weeks post-enrollment
  • Proportion of enrolled patients who receive at least 1 dose of vaccine at any time post-enrollment (cohorts A and B)Up to 44 weeks
  • Incidence of adverse events (AEs)Up to 24 weeks

    Defined as the proportion of subjects who experience at least one toxicity event per National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0. A toxicity event is defined as at least one grade 3 or 4 non-hematologic or grade 4 hematologic toxicity. Proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.