Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. pLADD is based on the attenuated form of Listeria monocytogenes that has been genetically modified to reduce its ability to cause disease, while maintaining its ability to stimulate a potent immune response. pLADD is manufactured using patient-specific antigens and is therefore individualized to each patient.

Official Title
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A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Biological: pLADD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>pLADD treatment cycle is once every 3 weeks; starting dose 1×10^8 colony-forming units (CFU) administered IV over 1 hour, and if tolerated increasing to 1×10^9 CFU | Biological: pLADD<br>* via IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0 | Through study completion, an average of 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, microsatellite stable (MSS)