ENROLLING_BY_INVITATION

Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer

Talk to us

Conditions

Metastatic Colorectal AdenocarcinomaMetastatic Pancreatic Ductal AdenocarcinomaStage IV Colorectal Cancer AJCC v7Stage IV Pancreatic Cancer AJCC v6 and v7Stage IVA Colorectal Cancer AJCC v7Stage IVB Colorectal Cancer AJCC v7

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study of the Feasibility and Safety of a Personalized Peptide Vaccine in Patients With Advanced Pancreatic Ductal Adenocarcinoma or Colorectal Adenocarcinoma

Quick Facts

Study Start:2016-05-11
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT02600949

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Any lines (including zero) of therapy prior to tissue harvest.
  3. * Adequate tumor tissue availability
  4. * Adults (age ≥ 18)
  5. * ECOG PS 0-1
  6. * Life expectancy \>12 months for Cohort C and \>9 months for Cohort D
  7. * Adequate organ and marrow function
  8. * Ability to understand and the willingness to sign a written informed consent document.
  9. * 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.
  10. * 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.
  1. * History of HIV or AIDS
  2. * Patients with brain metastasis
  3. * Serious autoimmune conditions
  4. * Use of chronic immune suppressive medications.
  5. * 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.
  6. * Women of child bearing potential who are pregnant or breastfeeding. Women with a positive pregnancy test at enrollment or prior to administration of vaccine. .
  7. * Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
  8. * Known history of active TB (Bacillus Tuberculosis).
  9. * Hypersensitivity to therapy drugs or their components.
  10. * Has a known additional malignancy that is progressing or requires active treatment.
  11. * Active coagulopathy.
  12. * History of arterial thrombosis within 3 months prior to starting study treatment.
  13. * History of New York Heart Association Class 3-4 heart failure or myocardial infarction within 6 months prior to starting therapy.
  14. * Known history of Hepatitis B or known active Hepatitis C.

Contacts and Locations

Principal Investigator

Michael J Overman
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Michael J Overman, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-05-11
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2016-05-11
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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