Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer
Trial ID or NCT#
NCT03189030
Status
NOT RECRUITING
Purpose
This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.
Official Title
A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- * metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)* able to provide adequate tumor tissue from at least 1 accessible tumor site* completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening* on maintenance standard-of-care chemotherapies or on treatment holiday* Eastern Cooperative Oncology Group (ECOG) 0 or 1* adequate organ function* progression of disease at the time of Enrollment
Exclusion Criteria:
- * BRAF V600E mutation* known allergy to both penicillin and sulfa drugs* implanted devices that cannot be easily removed* immunodeficiency, immune compromised state or receiving immunosuppressive therapy
Investigator(s)
George A. Fisher Jr.
Medical oncologist,
Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine
Tyler Johnson
Gastrointestinal specialist,
Medical oncologist
Clinical Associate Professor, Medicine - Oncology
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
