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Report for Clinical Trial NCT03189030

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03189030 Colorectal Neoplasms
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

1 Interventions

Name: pLADD

Description: via IV infusion
Type: Biological
Group Labels: 1

Treatment arm


Primary Outcomes

Description: Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0

Measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Time: Through study completion, an average of 12 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

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 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 Colorectal Neoplasms Colorectal Neoplasms 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. --- V600E ---

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 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 Colorectal Neoplasms Colorectal Neoplasms 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. --- V600E --- --- V600E ---



HPO Nodes


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