Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer
Pilot Study of the Feasibility and Safety of a Personalized Peptide Vaccine in Patients With Advanced Pancreatic Ductal Adenocarcinoma or Colorectal Adenocarcinoma
2 other identifiers
interventional
300
1 country
1
Brief Summary
This phase I trial studies the side effects and best way to give personalized peptide vaccine in patients with pancreatic or colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Personalized peptide vaccine is a vaccine developed from patient's own tumor cells and blood in order to use as a biological therapy. Biological therapies, such as personalized peptide vaccine may attack tumor cells and stop them from growing or kill them.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedStudy Start
First participant enrolled
May 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
April 24, 2026
April 1, 2026
11.1 years
November 6, 2015
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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)
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.
Up to 24 weeks
Secondary Outcomes (12)
Proportion of patients who have received at least one dose of vaccine that is alive and progression free defined based on response criteria according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
At 12 weeks post-vaccination (second re-staging scan)
Progression-free survival (cohorts A and B and C)
The time between the date of first vaccination and evidence of progression on computed tomography scan or the date of death due to any cause, assessed up to 6 months after the last dose of vaccine
Response rate (cohort A and B)
Up to 12 weeks
Change in tumor biomarker (CA19-9, carcinoembryonic antigen [CEA] or circulating free deoxyribonucleic acid [cfDNA] mutation)
Up to 6 months
Overall survival
The time from first vaccination to death, assessed up to 6 months after the last dose of vaccine
- +7 more secondary outcomes
Study Arms (3)
Cohort A (personalized vaccine, imiquimod)
EXPERIMENTALPatients 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.
Cohort B (personalized vaccine, imiquimod, pembrolizumab)
EXPERIMENTALPatients 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.
Cohort C and D (vaccine, imiquimod, pembrolizumab, APX005M)
EXPERIMENTALPatients 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.
Interventions
Undergo MRI
Applied topically
Given IV
Given IV
Undergo CT
Given SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- M.D. Anderson Cancer Centerlead
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Overman
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2015
First Posted
November 9, 2015
Study Start
May 11, 2016
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04