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New treatment option for Ras-mutated Metastatic Colorectal Cancer
Official title FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
ClinicalTrials.gov ID: NCT07446322
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ras-mutated metastatic colorectal cancer.
Also referred to as Avastin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab
You likely can't 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
See the full eligibility 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
- 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 study team makes the final eligibility decision.
Where it's taking place
- Homewood, Alabama, United States
- Beverly Hills, California, United States
- Encino, California, United States
- Koreatown, California, United States
- Los Angeles, California, United States
- West Covina, California, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- St Louis, Missouri, United States
- Florham Park, New Jersey, United States
- New Brunswick, New Jersey, United States
- Canton, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homewood, Alabama, United States; Beverly Hills, California, United States; Encino, California, United States; Koreatown, California, United States; Los Angeles, California, United States; West Covina, California, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.