Actively Recruiting
Pilot Study of the Feasibility and Safety of a Personalized Peptide Vaccine in Patients With Advanced Pancreatic Ductal Adenocarcinoma or Colorectal Adenocarcinoma
Led by M.D. Anderson Cancer Center ยท Updated on 2026-04-24
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates a personalized peptide vaccine designed from each patient's own tumor cells and blood to treat advanced pancreatic or colorectal cancer that has spread and is usually hard to control. The study is a phase I trial focusing on the feasibility and safety of this vaccine, alone or combined with other drugs, in patients with metastatic pancreatic ductal adenocarcinoma and colorectal cancer. It aims to understand how well the vaccine can be developed, its safety, and the immune responses it triggers. Participants are assigned to one of three groups receiving personalized synthetic tumor-associated peptide vaccines given under the skin on specific weeks, combined with topical imiquimod cream. Some groups also receive pembrolizumab intravenously every three weeks, and others receive sotigalimab intravenously after vaccination. Imaging scans such as CT or MRI are used at baseline and at regular intervals to monitor disease status. Treatment schedules vary by group, with doses given up to 24 weeks and follow-up extending to 6 months after treatment. Throughout the study, patients undergo scans, blood tests for tumor markers and immune responses, and monitoring for side effects. Researchers assess vaccine development success, adverse events, progression-free survival, tumor responses, and immune activity over time. The study includes safety monitoring up to 24 weeks and follow-up visits up to 6 months post-treatment to evaluate clinical outcomes and immune responses.
CONDITIONS
Brief Title
Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with metastatic colorectal cancer or pancreatic ductal adenocarcinoma
- Planned to or have undergone complete surgical resection (metastatectomy) or primary tumor resection for pancreatic cancer
- Any number of prior therapies allowed before tissue harvesting
- Adequate tumor tissue available for vaccine development
- ECOG Performance Status of 0 or 1
- Life expectancy greater than 12 months for Cohort C and greater than 9 months for Cohort D
- Adequate organ and marrow function
- Ability to understand and willing to sign informed consent
- Agreement to use adequate contraception during and after study participation if of child-bearing potential
- For Cohort C only: agree to post-operative blood draw for circulating tumor DNA testing within 6 weeks after surgery
You will not qualify if you...
- History of HIV or AIDS
- Brain metastases
- Serious autoimmune diseases
- Use of chronic immune suppressive medications
- Uncontrolled illnesses including active infections, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Pregnant or breastfeeding women or positive pregnancy test before vaccination
- History of non-infectious pneumonitis requiring steroids or interstitial lung disease
- Known active tuberculosis
- Hypersensitivity to study drugs or components
- Additional progressing malignancy requiring treatment
- Active blood clotting disorders
- Recent arterial thrombosis within 3 months before study treatment
- Severe heart failure or recent heart attack within 6 months
- Known active Hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive personalized synthetic tumor-associated peptide vaccine therapy subcutaneously on specified weeks, combined with imiquimod cream applied topically and, depending on cohort, pembrolizumab and sotigalimab infusions. Imaging scans are performed at baseline and various time points during treatment to monitor disease status.
Multiple visits for vaccine administration and drug infusions on day 1 of specified weeks, with imaging scans at baseline, weeks 0, 6, 12, 24, and every 3 months up to week 39
Duration - 6 months
Participants are monitored for safety and clinical outcomes after completion of study treatment.
Visits every 3 months for assessment
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here