New drug combo aims to stall endometrial cancer

NCT ID NCT07684599

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Sep 02, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether adding an experimental drug (GSK5733584) to standard immunotherapy can help keep advanced or recurrent endometrial cancer from growing. About 610 adults who have already completed initial chemotherapy with immunotherapy will receive either the new combination or usual care. The study measures how long participants live without their cancer worsening and checks for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GSK5733584 (an experimental drug) combined with immunotherapy (dostarlimab or pembrolizumab)
What this could lead to
If successful, this combination could become a new maintenance therapy to delay cancer progression in people with advanced endometrial cancer.
What could go wrong
This is an early-phase study, so the experimental drug may not improve outcomes or could cause side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 610 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF). * Has received 6 cycles of first-line therapy (i.e. induction therapy), consisting of platinum-based doublet chemotherapy (e.g., carboplatin/paclitaxel) with immune checkpoint inhibition as part of standard of care (either pembrolizumab or dostarlimab) or via trial Run-In (dostarlimab). Receipt of only 4 cycles of chemotherapy is permitted if chemotherapy was discontinued due to toxicity, provided that the participant received at least 12 weeks of immune checkpoint inhibitor therapy during the induction period. * Is able to commence C1D1 of study treatment within 3 - 9 weeks of the final dose of first-line therapy. * Is deemed suitable to continue with maintenance therapy with immune checkpoint inhibition (dostarlimab or pembrolizumab). * Demonstrates no clinical or radiographic progression of disease per investigator after the final dose of induction therapy. Final dose is defined as the last day that either platinum chemotherapy, taxane chemotherapy or immune checkpoint inhibition was given within the last cycle of induction therapy * Has histologically confirmed endometrial carcinoma including but not limited to endometrioid, serous, clear cell and endometrial carcinosarcoma. Mixed epithelial carcinomas are permitted. * Meets one of the following criteria: * Has newly diagnosed stage III disease \[2023 International Federation of Gynecology and Obstetrics (FIGO) staging\] with measurable residual disease \>1 cm after primary debulking surgery (incomplete cytoreduction). * Has newly diagnosed stage III disease (2023 FIGO staging) that is not suitable for primary debulking surgery with measurable disease. * Has newly diagnosed stage IV disease (2023 FIGO staging) and any residual disease status (measurable or non-measurable) following debulking surgery. Participants not suitable for primary debulking surgery are also permitted. * Has recurrent disease and is naïve to systemic anticancer therapy and any disease status (measurable or non-measurable). * Has recurrent disease after receiving prior neo-adjuvant/adjuvant systemic anticancer therapy and had a recurrence \>12 months after last dose of neo-adjuvant/adjuvant treatment. Participants with any disease status (measurable or non-measurable) are permitted. * Has a tumor demonstrating either Mismatch Repair proficient (MMRp) or Microsatellite stable (MSS). * Has provided a Formalin fixed, paraffin embedded (FFPE) tumor tissue sample sufficient for the central assessment of B7 homolog 4 protein (B7-H4) expression and MMR (if local MMRp/MSS test result(s) not available), with the result of B7-H4 expression testing available prior to date of randomization. * Is willing to use adequate contraception. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Mesenchymal tumors of the uterus (uterine sarcomas) and neuroendocrine uterine cancer. * Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas. * Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis. * Has experienced any of the following with prior immunotherapy: any imAE ≥ Grade 3, immune-mediated severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson syndrome \[SJS\], Toxic Epidermal Necrolysis \[TEN\], or Drug Reaction with Eosinophilia and Systemic Symptoms \[DRESS\] syndrome, or myocarditis of any grade. * Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤ Grade 1 or to the baseline status preceding prior therapy, excluding alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy, or adverse reactions that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study. * Has had any major surgery within 28 days prior to date of C1D1 or received focal radiotherapy within 21 days prior to date of C1D1. * Has received treatment with an investigational agent within 30 days prior to C1D1. * Has received prior therapy with topoisomerase I inhibitors (e.g. irinotecan or topotecan) or Antibody-Drug Conjugate (ADC)with a topoisomerase I inhibitor warhead, B7-H4 targeted therapy, or immune checkpoint inhibitor. * Has received treatment with inhibitors of P-glycoprotein (P-gp) or Breast cancer resistant protein (BCRP), or OATP1B1/1B3 transporterswithin 7 days prior to the date of C1D1. Inducers of P-gp should be discontinued for at least 14 days prior to the date of C1D1. * Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte-Colony Stimulating Factor \[G-CSF\], Granulocyte-Macrophage Colony-Stimulating Factor \[GM-CSF\], or recombinant erythropoietin) within 14 days prior to C1D1. * Has an Alanine aminotransferase (ALT) value \>2.5 × Upper limit of normal (ULN) or for participants with documented liver metastases/tumor infiltration has an ALT value \>5 × ULN. * Has a total bilirubin value \>1.5 × ULN. * Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. Participants who exhibit these signs or symptoms as a result of the malignancy under investigation and whose conditions are deemed adequately controlled by the investigator may be eligible for inclusion. * Has Corrected QT interval (QTc) \>470 milliseconds (msec). * Has a history of symptomatic pericarditis of any cause within 6 months prior to screening or evidence of cardiac abnormalities within 12 months prior to screening such as serious, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities. * Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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