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Immunotherapy in MSI/dMMR tumors in the perioperative setting: The IMHOTEP trial
- Source :
- Digestive and Liver Disease, Digestive and Liver Disease, 2022, 54 (10), pp.1335-1341. ⟨10.1016/j.dld.2022.07.008⟩
- Publication Year :
- 2022
- Publisher :
- HAL CCSD, 2022.
-
Abstract
- International audience; Background: Immune checkpoint inhibitors (ICI) targeting Programmed death-1 (PD-1) have shown their efficacy in advanced MSI/dMMR (microsatellite instability/deficient mismatch repair) tumors. The MSI/dMMR status predicts clinical response to ICI. The promising results evaluating ICI in localized MSI/dMMR tumors in neoadjuvant setting need to be confirmed in MSI/dMMR solid tumors. The aim of the IMHOTEP trial is to assess the efficacy of neoadjuvant anti-PD-1 treatment in MSI/dMMR tumors regarding the pathological complete response rate. Methods: This study is a prospective, multicenter, phase II study including 120 patients with localized MSI/dMMR carcinomas suitable for curative surgery. A single dose of pembrolizumab will be administered before the surgery planned 6 weeks later. Primary objective is to evaluate the efficacy of neoadjuvant pembrolizumab according to pathological complete tumor response. Secondary objectives are to assess safety, recurrence-free survival and overall survival. Ancillary studies will assess molecular and immunological biomarkers predicting response/resistance to ICI. First patient was enrolled in December 2021. Discussion: The IMHOTEP trial will be one of the first clinical trial investigating perioperative ICI in localized MSI/dMMR in a tumor agnostic setting. Assessing neoadjuvant anti-PD-1 is mandatory to improve MSI/dMMR patient's outcomes. The translational program will explore potential biomarker to improve our understanding of immune escape and response in this ICI neoadjuvant setting.
- Subjects :
- Hepatology
MSI/dMMR
[SDV]Life Sciences [q-bio]
Gastroenterology
Immune checkpoint inhibitor
DNA Mismatch Repair
Colorectal cancer
Perioperative immunotherapy
Antineoplastic Agents, Immunological
Endometrial cancer
Neoplasms
Humans
Immunologic Factors
Microsatellite Instability
Immunotherapy
Prospective Studies
Colorectal Neoplasms
Gastric cancer
Immune Checkpoint Inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 15908658
- Database :
- OpenAIRE
- Journal :
- Digestive and Liver Disease, Digestive and Liver Disease, 2022, 54 (10), pp.1335-1341. ⟨10.1016/j.dld.2022.07.008⟩
- Accession number :
- edsair.doi.dedup.....f54d5c46065bce3549e79b161db7c16c