Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study
Watch-and-wait Strategy to Initiate Dostarlimab-based Immunotherapy in Localized Deficient Mismatch Repair (dMMR) and/or Microsatellite Instability High (MSI-H) oEso-gastric Junction and Gastric Adenocarcinoma: An Open-label GERCOR Phase II Study
GERCOR - Multidisciplinary Oncology Cooperative Group
59 participants
Dec 18, 2023
INTERVENTIONAL
Conditions
Summary
This phase II study will evaluate dostarlimab with a watch-and-wait approach for patients with localized mismatch repair deficiency (dMMR)/microsatellite instability (MSI) gastric or oeso-gastric junction adenocarcinoma. The goal of the study is to determine whether the surgery could be avoided in patients with localized dMMR/MSI-H gastric/OGJ adenocarcinoma with complete response at endoscopy and biopsies free of tumoral cells after treatment with dostarlimab, with a watch-and-wait approaches.
Eligibility
Plain Language Summary
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Interventions
After inclusion: dostarlimab 500mg IV 30min q3w (± 2-3 days) for 4 cycles (C1-C4) Then: At wk12 • If cCR: dostarlimab 1000mg q6w for 2 cycles (C5-C6) • If downstaging at UGI endoscopy, and no disease progression (PD)/or mets on TAP-CT, \<3 biopsies with tumor cells: dostarlimab 500mg q3w for 4 cycles (C5-C8) • If loco/loco-regional PD on TAP-CT, macroscopic tumor on UGI endoscopy, no distant mets, and \>2 positive biopsies at wk12 followed by surgery and if Becker-TRG 1a, 1b, or 2 after surgery: dostarlimab 1000mg q6w for 6 cycles (C5-C10) At 24wk • If cCR at 12 and 24 wks: dostarlimab 1000mg q6w for 4 cycles (C7-C10) • If downstaging at UGI endoscopy without PD on CT at wk 12 with \<3 biopsies with tumor cells at wk12 and cCR: dostarlimab 1000mg q6w for 4 cycles (C9-C12) • If downstaging at UGI endoscopy without PD on CT at wk 12 with and no cCR, surgery will be proposed and if Becker-TRG 1a, 1b, or 2 after surgery: dostarlimab 1000mg q6w for 4 cycles (C9-C12)
Locations(2)
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NCT06059495