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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment60 people
  • Recruiting US sites19
  • SponsorOncolytics Biotech
  • RegistryNCT07446322

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer: a one-minute explainerNCT074463221 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

pelareorep. An isolate of the oncolytic, human wild-type serotype 3 Dearing (T3D) strain of the double-stranded RNA virus reovirus (Respiratory Enteric Orphan virus), with potential oncolytic activity. Upon administration, pelareorep is able to replicate specifically in cancer cells bearing an activated Ras pathway. This induces apoptosis in Ras-activated tumor cells and subsequently frees progeny viral particles to infect, replicate in and induce cell death of surrounding cancer cells. In addition, viral replication causes the activation of innate and adaptive immune responses, causing a natural killer (NK)-cell-mediated and a cytotoxic T-cell (CTL)-mediated killing of tumor cells, respectively. Ras-activated tumor cells are deficient in their ability to trigger the antiviral response mediated by the host cellular protein, double-stranded RNA-dependent protein kinase (PKR). NCI Drug Dictionary

bevacizumab. A recombinant humanized monoclonal antibody directed against the vascular endothelial growth factor (VEGF), a pro-angiogenic cytokine. Bevacizumab binds to VEGF and inhibits VEGF receptor binding, thereby preventing the growth and maintenance of tumor blood vessels. NCI Drug Dictionary

Treatments listed in the registry

  • Bevacizumab (Drug): Bevacizumab (5 mg/kg) IV infusion
  • FOLFIRI (Drug): irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion
  • Pelareorep (Drug): pelareorep 4.5 x 10^10 TCID50 IV infusion

The study

Treatment groups

Randomized · Parallel · masking: None

Arm A (Experimental)

Arm B (Experimental)

Goals

What the study measures

Main goals

  • Overall Response Rate (ORR) (At week 8)

Other goals

  • Overall Survival (OS) -
  • Progression Free Survival (PFS)
  • Disease Control Rate (DCR)
  • Duration of Response (DOR)

Planned enrollment: 60 (estimated).

Where

Recruiting US sites

  • Central Alabama Research, Homewood, Alabama
  • Clinical Research Advisors (Beverly Hills), Beverly Hills, California
  • Clinical Research Advisors (Encino), Encino, California
  • Clinical Research Advisors (Korea Town), Koreatown, California
  • Clinical Research Advisors (Downtown LA), Los Angeles, California
  • Clinical Research Advisors (West Hollywood), Los Angeles, California
  • Clinical Research Advisors (West Covina), West Covina, California
  • Moffitt Cancer Center, Tampa, Florida
  • Emory Winship Cancer Institute, Atlanta, Georgia
  • Beacon Cancer Center, Post Falls, Idaho
  • Northwestern Memorial Hospital, Chicago, Illinois
  • Community Health Network, Indianapolis, Indiana
  • Karmanos Cancer Institute, Detroit, Michigan
  • Washington University School of Medicine, St Louis, Missouri
  • Summit Health Cancer Center, Florham Park, New Jersey
  • Rutgers Cancer Institute, New Brunswick, New Jersey
  • Gabrail Cancer Center, Canton, Ohio
  • University of Cincinnati Medical Center, Cincinnati, Ohio
  • Ohio State University, Colombus, Ohio

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 26, 2026. Public record; not medical advice.

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