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Avelumab versus standard second line treatment chemotherapy in metastatic colorectal cancer patients with microsatellite instability: The SAMCO-PRODIGE 54 randomised phase II trial.

Abstract
Immune checkpoint inhibitors have failed in treating metastatic colorectal cancer (mCRC) patients except those with dMMR/MSI tumors. However, until very recently we had only non-comparative promising data in this population with anti-programmed cell death 1/ programmed cell death ligand 1 (PD1/PD-L1) antibodies alone or combined with anti- cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibodies. This comparative phase II trial (NCT03186326), conducted in more than 100 centers in France, will include dMMR/MSI mCRC patients with progression after a first-line treatment with chemotherapy ± targeted therapies, to evaluate efficacy and safety of the anti-PDL1 Avelumab versus a standard second-line treatment. Main inclusion criteria were patients aged 18 to 75 years, ECOG performance status ≤2, dMMR/MSI mCRC and failure of a standard first-line regimen. Patient will be randomised to receive Avelumab 10 mg/kg versus standard second-line doublet chemotherapy plus a targeted agent according to tumor RAS status. Patients will be followed for 4 years. A gain of 5 months in median PFS is expected in favour of the Avelumab arm (12 vs 7 months; HR=0.58). Secondary endpoints include objective response rate, overall survival, quality of life and toxicity. In addition, circulating tumour DNA and microbiota will be explored to test their potential prognostic and predictive values. The study was opened in March 2018.
AuthorsJulien Taïeb, Thierry André, Farid El Hajbi, Emilie Barbier, Clémence Toullec, Stefano Kim, Olivier Bouche, Frederic Di Fiore, Marion Chauvenet, Hervé Perrier, Ludovic Evesque, Pierre Laurent-Puig, Jean-François Emile, Jérémie Bez, Côme Lepage, David Tougeron
JournalDigestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver (Dig Liver Dis) Vol. 53 Issue 3 Pg. 318-323 (03 2021) ISSN: 1878-3562 [Electronic] Netherlands
PMID33359404 (Publication Type: Clinical Trial Protocol, Journal Article)
CopyrightCopyright © 2020 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
Chemical References
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents, Immunological
  • avelumab
Topics
  • Adult
  • Antibodies, Monoclonal, Humanized (administration & dosage)
  • Antineoplastic Agents, Immunological (administration & dosage)
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Clinical Trials, Phase II as Topic
  • Colorectal Neoplasms (drug therapy)
  • Female
  • France
  • Humans
  • Male
  • Microsatellite Instability
  • Multicenter Studies as Topic
  • Progression-Free Survival
  • Randomized Controlled Trials as Topic

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