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Avelumab + cetuximab + irinotecan in refractory metastatic MSS colorectal cancer
2018-001096-20Phase 2
Key facts
- Status
- Completed
- Start
- May 2018
- Countries
- 1
- Sponsor
- Cliniques universitaires Saint-Luc
- Modality
- Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label trial of avelumab, cetuximab and irinotecan in colorectal cancer (CRC) (2 cohorts), sponsored by Cliniques universitaires Saint-Luc. Primary endpoint: Overall tumor response rate (ORR). Started May 2018; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Cohort A: RAS wild-type
Patients with RAS wild-type metastatic microsatellite stable colorectal cancer receiving avelumab + cetuximab + irinotecan.
Cohort B: RAS-mutated
Patients with RAS-mutated metastatic microsatellite stable colorectal cancer receiving avelumab + cetuximab + irinotecan.
03
Who it enrols
Adults (≥18 years) with treatment-refractory metastatic microsatellite stable colorectal cancer, enrolled into separate cohorts based on RAS mutation status (wild-type or mutated); tumors with BRAF V600E mutation or microsatellite instability-high (MSI-H) status are excluded.
04
Endpoints
Primary
Overall tumor response rate (ORR)
Secondary
Safety and tolerability
Efficacy (exploratory)
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