pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer

NCT ID: NCT07115927

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2031-01-31

Brief 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.

Detailed Description

Background Endometrial cancer is the most common invasive gynaecological malignancy and its incidence is predicted to double by 2030. Surgery remains the most effective treatment modality to cure operable early-stage and high-risk cancers but despite the use of adjuvant therapies, a proportion of patients will relapse due to the presence of micrometastases that cannot be detected at the time of primary treatment. Immune checkpoint inhibitors have been evaluated in endometrial cancer, for example, the GARNET trial demonstrated the benefit of dostarlimab (anti-PD1) in women with relapsed/advanced endometrial cancer. Pre-operative immunotherapy is an evolving strategy that consists of administering an ICI, either as monotherapy or in combination before surgical resection in high-risk resectable disease, in the window between diagnosis and primary surgery

Aims RODEO is a proposed window trial using dostarlimab in patients with newly diagnosed high-risk (stage 2-4)endometrial cancer who are suitable for primary 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.

Methods Patients will receive 2 doses of dostarlimab (500mg IV day 1 and day 22) prior to surgery.

How the results of this research will be used. This trial will investigate the efficacy and safety of dostarlimab in this setting and multiple translational and clinical endpoints will be explored. It will provide a unique opportunity to study the immune microenvironment in treatment naïve tumours and help determine key mechanisms involved in the response and resistance to therapy, with the potential to develop biomarkers which may elucidate response beyond MMR status, so widening the potential benefit of this agent and assisting in future patient selection.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dostarlimab

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

9. Patient must have a negative serum pregnancy test within 24 hours prior to the date of the first dose of trial medication; unless they are of non-childbearing potential.

Non-childbearing potential is defined as:

i. ≥ 45 years of age and has not had menses for > 1 year. ii. Amenorrheic for < 2 years without a hysterectomy and oophorectomy and have a follicle-stimulating hormone (FSH) value in the postmenopausal range upon pre-trial evaluation.

10. Patients should have adequate bone marrow and laboratory functions defined as:

• Absolute neutrophil count (ANC) ≥1.5×109/L
• Haemoglobin ≥9 g/dL ≥5.6 mmol/L
• Platelets ≥100×109/L
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5×ULN
• Bilirubin ≤1.5×ULN (isolated bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%)
• For patients not taking warfarin: International normalized ratio (INR) <1.5 or prothrombin time (PT) <1.5×ULN and partial thromboplastin (PTT) <1.5×ULN. Patients taking warfarin may be included on a stable dose with a therapeutic INR <3.5.
• Renal function parameters of GFR ≥30 mL/min/1.73m2 (institutional creatinine ≤1.5×ULN)
• Albumin > 30

11. ECOG Performance Status 0 or 1.

12. Life expectancy of at least 3 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Katie Wilkinson, BSc

Role: CONTACT

ctc.RODEO@ucl.ac.uk

+44 20 31088123

RODEO Trial Manager

Role: CONTACT

ctc.RODEO@ucl.ac.uk

Other Identifiers

UCL/157607

Identifier Type: -

Identifier Source: org_study_id