An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer
Primary Objective:
To assess the efficacy, in terms of ORR, of FOLFIRI + bevacizumab + pelareorep (Arm A) compared with FOLFIRI + bevacizumab (Arm B) in 2L patients with RAS-mutated, MSS metastatic colorectal cancer (mCRC).
Secondary Objectives:
To assess PFS in both treatment arms.
To assess OS in both treatment arms.
To assess the DCR in both treatment arms.
To assess the DOR in both treatment arms.
To assess the safety and tolerability of FOLFIRI + bevacizumab + pelareorep (Arm A) and of FOLFIRI + bevacizumab (Arm B).
Folfiri
Pelareorep
- Rutgers University
Inclusion Criteria: - Histologically confirmed cancer of the colon or rectum with documented metastasis - Measurable disease per RECIST v. 1.1 - Not candidates for curative surgery or curative radiation - Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in the metastatic setting or relapsed within 6 months of completing adjuvant oxaliplatin - Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab - Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non dMMR) tumor status per a standard local testing method - Tumor confirmed to harbor a known RAS mutation per a standard local testing method - ECOG performance status of 0 or 1 - Patients must have adequate hematological, renal, and hepatic function - Female patients of childbearing potential must have a negative pregnancy test - Life expectancy of at least 6 months Exclusion Criteria: - Undergone systemic chemotherapy, radiotherapy, or surgery, <4 weeks before study treatment - Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment - Prior treatment with irinotecan - Symptomatic brain metastases - Active autoimmune disease - Receiving immunosuppressive or myelosuppressive medications - Active, uncontrolled infections - Known HIV infection or active hepatitis B or C that requires anti-viral treatment - History of another primary cancer within the last 3 years except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ - History of allergy or known hypersensitivity to any of the study drugs, study drug classes, - Uncontrolled or severe cardiac disease - Received any vaccine within 28 days prior to first study treatment
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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