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FOLFIRI + Cetuximab + Avelumab RAS Wild-type CRC

NCT05217069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-04-16

No results posted yet for this study

Summary

Within the proposed single arm multicenter phase-II trial it is intended to investigate the feasi-bility of adding Avelumab to FOLFIRI plus Cetuximab after 4 cycles (2 months) of treatment with FOLFIRI plus Cetuximab. After 4 more cycles of FOLFIRI plus Cetuximab plus Avelumab the treatment will be de-escalated to Avelumab as a maintenance concept until progression of the disease according to RECIST 1.1 has occurred.

Conditions

  • Treatment Related Cancer

Interventions

DRUG

5-FU

400 mg/m2 (i.v. bolus) 2400 mg/m2 (i.v. 46h)

DRUG

Folinic Acid

400mg/m2

DRUG

Irinotecan

180 mg/m2

DRUG

Cetuximab

400 mg/m2 i.v. 120min initial dose 250 mg/m2 i.v. 60min q 1w

DRUG

Avelumab

10mg/kg IV (day 1 q2w)

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • ClinAssess GmbH

    collaborator INDUSTRY

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Dominik Modest, PD Dr. · Ludwig-Maximilians - University of Munich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2023-09-01
Completion
2023-10-18

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 NCT05217069 on ClinicalTrials.gov