Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer
NCT ID: NCT02600949
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE1
150 participants
INTERVENTIONAL
2016-05-11
2027-05-31
Brief Summary
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Detailed Description
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I. Demonstrate that developing a custom vaccine for metastatic pancreatic ductal adenocarcinoma (PDA) and colorectal cancer (CRC) patients is feasible. (cohorts A and B)
II. Show that a custom peptide-based vaccine in combination with imiquiomod, pembrolizumab, and/or sotigalimab (APX005M) is safe. (cohorts A and B and C and D)
SECONDARY OBJECTIVES:
I. Determine the clinical benefit of the peptide vaccine alone or combined with pembrolizumab or pembrolizumab and APX005M. (cohorts A and B and C and D)
II. Demonstrate the antigenicity of each vaccine. (cohorts A and B and C and D)
III. The change in neoantigen-specific T cell responses at 12 weeks after initiation of personalized peptide vaccination. (cohorts C and D)
IV. Relapse-free survival and circulating tumor deoxyribonucleic acid (ctDNA) clearance rate. (cohorts C and D)
OUTLINE: Patients are assigned to 1 of 3 cohorts.
COHORT A: Patients receive personalized synthetic tumor-associated peptide vaccine therapy subcutaneously (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 computed tomography (CT) or magnetic resonance imaging (MRI) scans at baseline and at weeks 0 and 6, then every 3 months, and at week 39.
COHORT B: 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 intravenously (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.
COHORTS C AND D: 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, 9, 12, 15, 18, 21, 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.
After completion of study treatment, patients are followed for 6 months.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A (personalized vaccine, imiquimod)
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.
Imiquimod
Applied topically
Synthetic Tumor-Associated Peptide Vaccine Therapy
Given SC
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Cohort B (personalized vaccine, imiquimod, pembrolizumab)
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.
Imiquimod
Applied topically
Pembrolizumab
Given IV
Synthetic Tumor-Associated Peptide Vaccine Therapy
Given SC
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Cohort C and D (vaccine, imiquimod, pembrolizumab, APX005M)
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.
Imiquimod
Applied topically
Pembrolizumab
Given IV
Sotigalimab
Given IV
Synthetic Tumor-Associated Peptide Vaccine Therapy
Given SC
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Interventions
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Imiquimod
Applied topically
Pembrolizumab
Given IV
Sotigalimab
Given IV
Synthetic Tumor-Associated Peptide Vaccine Therapy
Given SC
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michael J Overman
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2016-00015
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-1029
Identifier Type: OTHER
Identifier Source: secondary_id
2014-1029
Identifier Type: -
Identifier Source: org_study_id
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