Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer
NCT02600949 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-04-24
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.
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
Interventions
- DRUG
-
Imiquimod
Applied topically
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Sotigalimab
Given IV
- BIOLOGICAL
-
Synthetic Tumor-Associated Peptide Vaccine Therapy
Given SC
- PROCEDURE
-
Computed Tomography
Undergo CT
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Michael J Overman · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-11
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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