Avelumab Combined With Cetuximab and Irinotecan for Treatment Refractory Metastatic Colorectal Microsatellite Stable Cancer

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ID
NCT03608046
Phase
PHASE2
Status
Unknown

Conditions

  • Colorectal Neoplasms, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Avelumab — DRUG
    Avelumab will be administered at a fixed dose of 10 mg/kg once every 2- week
  • Cetuximab Injection — DRUG
    Cetuximab will be administered at 400 mg/m2 loading dose week 1, 250 mg/m2 from week 2 followed by 500 mg/m2 from week 3 and irinotecan administered every 2 weeks (180 mg/m2).
  • Irinotecan — DRUG
    Irinotecan will be administered every 2 weeks (180 mg/m2)

Study Details

Cancer immunotherapy with immunostimulatory antibodies targeting the CTLA-4 or PD-1/PD-L1 pathways has demonstrated its efficacy in variable proportions of cancer. For metastatic colorectal cancer (mCRC) it appeared that only the small subgroup of patients with MSI-H tumors (microsatellite instability-high phenotype) had a clinically meaningful response to the anti-PD-1- L1 antibodies. In the majority group of non-MSI-H CRC (90-95% of patients), current research expect that additional means would be able to render the tumor "immunogenic" (like MSI-H CRC) and increase the intratumoral immune infiltrate which is the prerequisite to observe a benefit from PD1-PD-L1 inhibitors. Combinations of immune checkpoint inhibitors and procedures that increase intratumoral immune responses, such as targeted therapy, are actively explored.

Key Dates

Start date
Oct 3, 2018
Status verified
Oct 2020
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
59 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Avelumab, Cetuximab, Irinotecan
    Avelumab : administrated at a fixed dose of 10 mg/kg once every 2- week. Cetuximab: administered at 400 mg/m2 loading dose week 1, 250 mg/m2 from week 2 followed by 500 mg/m2 from week 3. Irinotecan: administrated every 2 weeks (180 mg/m2).

Primary Outcome Measure

Tumor response rate [ Time Frame: Up to 19 weeks ]

Central Contacts