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Endometrial CancerPhase 2RODEONCT07115927

pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer

A Phase 2 study testing Dostarlimab in people with Endometrial Cancer, run by University College, London.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Dostarlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
30 Sep 2025to 31 Jan 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult
  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:
  10. ≥ 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.
  11. 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
  1. ECOG Performance Status 0 or 1.
  2. Life expectancy of at least 3 months.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Katie Wilkinson, BSc contact

+44 20 31088123

ctc.RODEO@ucl.ac.uk

RODEO Trial Manager contact

ctc.RODEO@ucl.ac.uk

About this study

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.

Read the 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.

Being tested
Dostarlimab
Keywords
Window of opportunity
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DostarlimabDrug

    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 groups in NCT07115927
Study groupRoleWhat they receive
Arm 1: Dostarlimab monotherapyExperimentalPatients 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.
Receives: Drug: Dostarlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start30 Sep 2025 (estimated)
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion31 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Window of opportunity. This trial has been designed to run as a platform trial. Additional arms are in development.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07115927
Sponsor's protocol ID
UCL/157607
Acronym
RODEO
Status last verified
Aug 2025
First submitted
4 Aug 2025
Last updated
19 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab in people with Endometrial Cancer, run by University College, London.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katie Wilkinson, BSc (+44 20 31088123, ctc.RODEO@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological response rate (time frame: At time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07115927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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