Personalized peptide vaccine for advanced pancreatic and colorectal cancer
Pilot Study of the Feasibility and Safety of a Personalized Peptide Vaccine in Patients With Advanced Pancreatic Ductal Adenocarcinoma or Colorectal Adenocarcinoma
This study is testing a personalized vaccine made from patients' own tumor cells to see if it can help people with advanced pancreatic and colorectal cancer feel better when combined with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | pembrolizumab, sotigalimab |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02600949 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the feasibility and safety of a personalized peptide vaccine designed from patients' own tumor cells and blood to treat advanced pancreatic and colorectal cancer. Patients will receive the vaccine along with other treatments like imiquimod and pembrolizumab to enhance immune response against their tumors. The study aims to assess the clinical benefits, safety, and immune responses generated by the vaccine over a series of treatment cycles. Patients will be monitored through imaging and blood tests to evaluate treatment effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with metastatic pancreatic ductal adenocarcinoma or metastatic colorectal cancer who have had at least one line of standard chemotherapy.
Not a fit: Patients with early-stage cancer or those who have not undergone any prior chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with advanced pancreatic and colorectal cancers.
How similar studies have performed: Other studies have shown promise with personalized vaccine approaches in cancer treatment, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Michael J Overman — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.