FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bevacizumab, FOLFIRI, Pelareorep.
- Who it may be relevant to
- Registry conditions: Ras-mutated Metastatic Colorectal Cancer, mCRC, MSS Metastatic Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer
Overview
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.
Detailed description
Approximately 60 patients will be randomized 1:1 to the following study arms:
* Arm A: FOLFIRI + bevacizumab + pelareorep * Arm B: FOLFIRI + bevacizumab The primary endpoint is ORR as assessed by the investigator per RECIST 1.1. OS, PFS, and assessment of the safety and tolerability of the study treatment combinations are secondary endpoints. The primary endpoint analysis will be performed after all patients have had at least one tumor assessment following initiation of study treatment or have progressed. The secondary endpoint analyses will take place at EOS.
Interventions
- Drug Bevacizumab
Bevacizumab (5 mg/kg) IV infusion - Drug FOLFIRI
irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion - Drug Pelareorep
pelareorep 4.5 x 10\^10 TCID50 IV infusion
Primary outcome measures
- Overall Response Rate (ORR) [Time frame: At week 8]
Secondary outcome measures (4)
- Overall Survival (OS) - [Time frame: From the date of randomization through long term follow up at two years]
- Progression Free Survival (PFS) [Time frame: From randomization to objective progression or death from any cause, whichever occurs first, up to two years]
- Disease Control Rate (DCR) [Time frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years]
- Duration of Response (DOR) [Time frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- Central Alabama Research — Homewood
- Clinical Research Advisors (Beverly Hills) — Beverly Hills
- Clinical Research Advisors (Encino) — Encino
- Clinical Research Advisors (Korea Town) — Koreatown
- Clinical Research Advisors (Downtown LA) — Los Angeles
- Clinical Research Advisors (West Hollywood) — Los Angeles
- Clinical Research Advisors (West Covina) — West Covina
- Emory Winship Cancer Institute — Atlanta
- … and 5 more centers
Identifiers
NCT: NCT07446322 · REO 033