FOLFIRI + Cetuximab + Avelumab RAS Wild-type CRC

Conditions

• Treatment Related Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 5-FU — DRUG
  400 mg/m2 (i.v. bolus) 2400 mg/m2 (i.v. 46h)
• Folinic Acid — DRUG
  400mg/m2
• Irinotecan — DRUG
  180 mg/m2
• Cetuximab — DRUG
  400 mg/m2 i.v. 120min initial dose 250 mg/m2 i.v. 60min q 1w
• Avelumab — DRUG
  10mg/kg IV (day 1 q2w)

Study Details

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.

Key Dates

Start date

Sep 27, 2019

Status verified

Apr 2025

Primary completion

Sep 1, 2023

Completion

Oct 18, 2023

Study Design

Enrollment

57 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: RAS wild-type Avelumab
  Induction therapy: FOLFIRI 5-FU: 400 mg/m2 (i.v. bolus) Folinic acid: 400mg/m2 Irinotecan: 180 mg/m2 5-FU: 2.400 mg/m2 (i.v. 46h) Cetuximab 400 mg/m2 i.v. 120min initial dose 250 mg/m2 i.v. 60min q 1w Maintenance therapy: Avelumab 10mg/kg IV (day 1 q2w)

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: up to 8 months ]