FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer

Conditions

• MSS Metastatic Colorectal Cancer
• Ras-mutated Metastatic Colorectal Cancer
• mCRC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  Bevacizumab (5 mg/kg) IV infusion
• FOLFIRI — DRUG
  irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion
• Pelareorep — DRUG
  pelareorep 4.5 x 10\^10 TCID50 IV infusion

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Jun 2026

Primary completion

Aug 30, 2027

Completion

Apr 30, 2030

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
• Experimental: Arm B

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: At week 8 ]

Central Contacts

• Name: Reference Study ID Number: REO 033
  +1 (858) 247- 7829
  [email protected]

Locations (3)

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