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pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer

NCT07115927 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-19

No results posted yet for this study

Summary

RODEO is a window of opportunity trial using dostarlimab in patients with newly diagnosed high-risk (stage 2-4) endometrial cancer who are suitable for primary surgery. Patients will receive 2 doses of dostarlimab (500mg IV day 1 and day 22) prior to surgery. The primary objective is to assess the pathological response rate to pre-operative dostarlimab and the secondary objectives are to assess the feasibility, toxicity, safety and efficacy of pre-operative dostarlimab.

Conditions

Interventions

DRUG

Dostarlimab

Arm 1: Patients in the initial cohort will be treated with two doses of dostarlimab prior to surgery, receiving dostarlimab 500mg IV on day 1 and day 22.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University College, London

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2030-04-30
Completion
2031-01-31

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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 NCT07115927 on ClinicalTrials.gov