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

Official record

Identifier

NCT07446322

Recruiting locations

country

United States

Interventions studied

BevacizumabFOLFIRIPelareorep

Lead sponsor

Oncolytics Biotech

Target enrolment

60 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Mar 3, 2026

Last updated on the registry

Sep 29, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Colorectal Cancer