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Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study

NCT06059495 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-02-05

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma - GEJ
  • Gastric Adenocarcinoma

Interventions

DRUG

Dostarlimab

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)

Sponsors & Collaborators

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Thierry Andre, MD · Saint-Antoine Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2028-09-01
Completion
2028-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059495 on ClinicalTrials.gov