pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer

Sponsor
University College, London
Study ID
NCT07115927
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2030
Completion
Jan 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Dostarlimab monotherapy
    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.

Primary Outcome Measure

Pathological response rate [ Time Frame: At time of surgery ]

Central Contacts

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