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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    59
  • sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Updated on 26 January 2021

Summary

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.

Details
Condition Colorectal Neoplasms Malignant
Treatment Irinotecan, Avelumab, Cetuximab Injection
Clinical Study IdentifierNCT03608046
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 and over, Performance status: ECOG 0-1
Histologically proven metastatic colorectal adenocarcinoma, refractory to standard chemotherapy (fluoropyrimidine, oxaliplatin, irinotecan) and anti-EGFR treatment (only for RAS WT tumor)
Measurable disease (RECIST 1.1)
Metastasis accessible for sequential biopsies
Patient consent for metastasis biopsies in the study protocol
BRAF V600E wild-type and MSS tumors
Adequate normal organ and marrow function (see adequate section of the full protocol for definition)
Life expectancy of at least 4 months

Exclusion Criteria

Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy that are not indicated in the study protocol
Systemic autoimmune disease
Chronic treatment with corticoids or other immunosuppressive treatment
Clinically significant cardiac, lung or general disease despite optimal treatment
Non-progressive disease following irinotecan-based treatment
For RAS WT, non-progressive disease following anti-EGFR treatment
Clear my responses

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