No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Oncolytics Biotech · Industry
Who this trial is looking for
This trial is looking for people with specific types of colorectal cancer who have not responded to earlier treatments. If you join, you would receive either an additional treatment or follow standard care as part of the study.
Are You a Good Fit for This Trial?
Rules you outSymptomatic brain metastasesActive autoimmune diseaseActive, uncontrolled infectionsKnown HIV infectionActive hepatitis B or C
You may be able to join if
I have been diagnosed with cancer of the colon or rectum that has spread.
I have measurable disease.
I am not a candidate for surgery or radiation to cure my cancer.
I have progressed after or not tolerated a first-line oxaliplatin-based chemotherapy.
I am eligible to receive FOLFIRI and bevacizumab.
I have a tumor with a known RAS mutation.
My performance status is ECOG 0 or 1.
I have a life expectancy of at least 6 months.
You may not be able to join if
I have undergone chemotherapy, radiation, or surgery in the last 4 weeks.
I have ongoing severe side effects from cancer treatment.
I have had prior treatment with irinotecan.
I have brain metastases that cause symptoms.
I have an active autoimmune disease.
I have uncontrolled infections.
I have a known HIV infection or active hepatitis B or C.
I have had another primary cancer in the last 3 years except for specific cases.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
Eligibility 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 …
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
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