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

NCT04554836 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-06-08

Study results available
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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

DRUG

Cetuximab

Patients in Arm A will receive FOLFIRI +cetuximab.

OTHER

FOLFIRI

Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)

Sponsors & Collaborators

  • TheraOp

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2024-06-11
Completion
2024-06-11

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04554836 on ClinicalTrials.gov