NCT04554836

MoLiMoR - A Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab

Modulation of the FOLFIRI-based Standard First-line Therapy With Cetuximab, Controlled by Monitoring the RAS (Rat Sarcoma) Mutation Load by Liquid Biopsy in RAS-mutated mCRC (Metastatic Colorectal Cancer): A Randomized Phase II Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab (MoLiMoR)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: TheraOp · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, prospective, randomized, multicenter phase II trial that will evaluate the efficacy and safety of intermittent addition of cetuximab to a FOLFIRI-based first line therapy to patients with RAS (Rat sarcoma)-mutant mCRC (Metastatic colorectal cancer) diagnosis who convert to RAS wild-type using monitoring of the RAS mutation status by liquid biopsy.

Conditions

• Adenocarcinoma of the Colon
• Adenocarcinoma of the Rectum

Interventions

Type	Name	Description
DRUG	Cetuximab	Patients in Arm A will receive FOLFIRI +cetuximab.
OTHER	FOLFIRI	Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)

Timeline

• Start date: 2020-12-29
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2020-09-18
• Last updated: 2025-06-08
• Results posted: 2025-06-08

Locations

4 sites across 1 country: Germany