pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer

NCT07115927 | Not Yet Recruiting Phase 2

• 1 other identifier: UCL/157607
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrial Cancer

Keywords

Window of opportunity

Outcome Measures

Primary Outcomes (1)

• Pathological response rate

  To assess the pathological response rate to pre-operative treatment in patients with operable (FIGO (2009) stage 3-4) endometrial cancer

  At time of surgery

Study Arms (1)

Arm 1: Dostarlimab monotherapy

EXPERIMENTAL

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.

Drug: Dostarlimab

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.

Arm 1: Dostarlimab monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Patient is at least 18 years of age. 2. Patient is able to provide informed consent and able to comply with treatment and follow up schedule. 3. Patients with surgically operable FIGO (2009) stage 3-4 endometrial cancer. 4. Must not have received any systemic anti-cancer treatment (including chemotherapy, hormonal therapy, immunotherapy, surgical intervention, radiotherapy) for the current diagnosis of endometrial cancer. 5. Histological diagnosis of advanced epithelial endometrial cancer (excluding carcinosarcoma). 6. CT or MRI proven disease (measurable or non-measurable). 7. Willing to provide tissue from archival diagnostic sample, a newly obtained core or excisional biopsy of a tumour lesion at screening and also collection of tissue during surgery. 8. Mismatch repair status must be known at time of enrolment. Patients can be screened based on local MMR/MSI testing results using immunohistochemistry (IHC), polymerase chain reaction (PCR), or next generation sequencing (NGS) performed in a certified local laboratory, i. MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined locally. ii. MSI status as determined by polymerase chain reaction (PCR) or by tissue Next generation sequencing (NGS). Note: Patients who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) and have dMMR or MSI-H in the tumour are eligible to participate. 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College, London: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

dostarlimab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Katie Wilkinson, BSc

CONTACT

+44 20 31088123; ctc.RODEO@ucl.ac.uk

RODEO Trial Manager

CONTACT

ctc.RODEO@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Window of opportunity. This trial has been designed to run as a platform trial. Additional arms are in development.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): January 31, 2031
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share