Clinical Trial 24415

• Overview

  Study Title:

  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

  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.

  Objective:

  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).

• Treatments

  Therapies:

  Anti-VEGF Inhibitor; Chemotherapy; Immunotherapy

  Medications:

  5-fluorouracil (); Avastin (Bevacizumab); Bevacizumab (); CPT-11 (irinotecan); Camptosar (irinotecan); Pelareorep (); irinotecan (); leucovorin ()

• Inclusion Criteria

  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

  Exclusion Criteria:
  • Undergone systemic chemotherapy, radiotherapy, or surgery, > 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

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