Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

Not Recruiting

Trial ID: NCT03189030

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

Stanford Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine

Tyler Johnson
Tyler Johnson

Clinical Associate Professor, Medicine - Oncology

Eligibility

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

Intervention(s):

biological: pLADD

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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