New drug combo aims to stall endometrial cancer
NCT ID NCT07684599
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 Hide 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Endometrial cancer are added.
By submitting, you agree to our Terms of use
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
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug shrink tumors that resist standard care?
- Can protein patterns in stored tumors point to new treatment targets?
- Can fewer, stronger radiation doses spare the bowel in gynecologic cancers?
- Can one surgery treat endometrial cancer and obesity together?
- Can a pill target cancers with a specific gene flaw?
- Why is endometrial cancer often advanced in brazil? a new study digs into the data