FOLFIRI + Bevacizumab ± Pelareorep for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Name: Reference Study ID Number: REO 033

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oncolytics Biotech

Must be taking: FOLFIRI, Bevacizumab

Must not be taking: Immunosuppressive, Myelosuppressive

Disqualifiers: Brain metastases, Autoimmune disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a woman who can have children and my pregnancy test is negative.

I have colon or rectal cancer that has spread to other parts of my body.

* Measurable disease per RECIST v. 1.1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FOLFIRI + bevacizumab + pelareorep or FOLFIRI + bevacizumab

8 weeks

Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Periodic visits for assessment

What Are the Treatments Tested in This Trial?

Interventions

• Bevacizumab
• FOLFIRI
• Pelareorep

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 2 Interventions

Group II: Arm A Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Oncolytics Biotech

Lead Sponsor

Trials

21

Recruited

1,000+