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RecruitingInterventionalPhase 2

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

NCT ID: NCT07446322Sponsor: Oncolytics BiotechLast updated: 2026-06-08

Summary

This is an open-label, randomized, multicenter Phase 2 study to assess the efficacy and safety of FOLFIRI + bevacizumab + pelareorep vs. FOLFIRI + bevacizumab in patients with RAS-mutated, MSS mCRC who have progressed after one prior line of oxaliplatin-based therapy.

Detailed description

Approximately 60 patients will be randomized 1:1 to the following study arms: * Arm A: FOLFIRI + bevacizumab + pelareorep * Arm B: FOLFIRI + bevacizumab The primary endpoint is ORR as assessed by the investigator per RECIST 1.1. OS, PFS, and assessment of the safety and tolerability of the study treatment combinations are secondary endpoints. The primary endpoint analysis will be performed after all patients have had at least one tumor assessment following initiation of study treatment or have progressed. The secondary endpoint analyses will take place at EOS.

Arms & interventions

  • DrugBevacizumab

    Bevacizumab (5 mg/kg) IV infusion

  • DrugFOLFIRI

    irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion

  • DrugPelareorep

    pelareorep 4.5 x 10\^10 TCID50 IV infusion

Outcome measures

Primary

  • Overall Response Rate (ORR)

    Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1

    Time frame: At week 8

Secondary

  • Overall Survival (OS) -

    Time frame: From the date of randomization through long term follow up at two years

  • Progression Free Survival (PFS)

    Time frame: From randomization to objective progression or death from any cause, whichever occurs first, up to two years

  • Disease Control Rate (DCR)

    Time frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years

  • Duration of Response (DOR)

    Time frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (3)

Central Alabama Research

Homewood, Alabama, 35209

Recruiting

Summit Health Cancer Center

Florham Park, New Jersey, 07932

Recruiting

Gabrail Cancer Center

Canton, Ohio, 44718

Recruiting
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer | Cancerify