Study on FOLFIRI and Bevacizumab With or Without Pelareorep for Treating Advanced RAS-Mutated Colorectal Cancer
Sponsor: Oncolytics Biotech
ClinicalTrials ID:NCT07446322
This clinical trial is testing whether adding the drug pelareorep to the standard treatment of FOLFIRI and bevacizumab can improve outcomes for patients with advanced colorectal cancer that has a specific genetic mutation and has not responded to initial treatments.
Patient Parameters
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Program Overview
This study is exploring the effectiveness and safety of adding a new drug, pelareorep, to the standard treatment of FOLFIRI and bevacizumab for patients with advanced colorectal cancer that has a RAS mutation and is microsatellite-stable (MSS). The trial involves patients whose cancer has progressed after receiving an oxaliplatin-based treatment. Participants will be randomly assigned to receive either the standard treatment with or without pelareorep, and researchers will compare the outcomes to see if the addition of pelareorep offers any benefits.
Description
In this study, about 60 patients will be randomly divided into two groups:
- Group A will receive FOLFIRI, bevacizumab, and pelareorep.
- Group B will receive FOLFIRI and bevacizumab without pelareorep.
The main goal is to see how well the cancer responds to these treatments, measured by the overall response rate (ORR). Researchers will also look at overall survival (OS), progression-free survival (PFS), and how safe and tolerable the treatments are. The primary analysis will occur after all patients have had at least one tumor assessment or if their cancer has progressed. Secondary analyses will be conducted at the end of the study.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with colorectal cancer that has spread to other parts of the body.
- Cancer can be measured using standard criteria.
- Not eligible for surgery or radiation that could cure the cancer.
- Cancer has worsened after initial treatment with oxaliplatin-based chemotherapy or returned within 6 months after completing such treatment.
- Eligible to receive standard FOLFIRI and bevacizumab treatment.
- Cancer does not have high microsatellite instability or mismatch repair deficiency.
- Cancer has a known RAS mutation.
- In good overall health with an ECOG performance status of 0 or 1.
- Have adequate blood, kidney, and liver function.
- Female patients of childbearing age must have a negative pregnancy test.
- Expected to live at least 6 more months.
Exclusion Criteria
- Received chemotherapy, radiation, or surgery less than 4 weeks before starting the study treatment.
- Have ongoing side effects from previous cancer treatments that are moderate or severe.
- Previously treated with irinotecan.
- Have symptoms from cancer that has spread to the brain.
- Have an active autoimmune disease.
- Taking medications that suppress the immune system or bone marrow.
- Have active, uncontrolled infections.
- Have HIV or active hepatitis B or C that requires treatment.
- Had another type of cancer in the last 3 years, except for certain skin, prostate, or cervical cancers.
- Have allergies or known sensitivity to any of the study drugs.
- Have uncontrolled or severe heart disease.
- Received any vaccine within 28 days before starting the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Central Alabama Research | 35209 | Homewood | Alabama |
| Summit Health Cancer Center | 07932 | Florham Park | New Jersey |
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