The purpose of this study is to see how well GSK5733584 in combination with standard treatment of choice works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared to current standard of care. The study will also assess whether drug combination is safe and tolerated well by participants compared to the usual care and will help us better understand its impact on Health-Related Quality of Life of participants.
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 (carboplatin/paclitaxel) with immune checkpoint inhibition as part of standard of care (either pembrolizumab or dostarlimab) or via trial Run-In (dostarlimab). Completion of 4 cycles is permitted if the reason for discontinuation of therapy was due to chemotherapy toxicity and the participant has completed at least 12 weeks of immunotherapy during induction.
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
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.
Parallel
GSK5733584
DrugGSK5733584 will be administered
Dostarlimab
DrugDostarlimab will be administered
Pembrolizumab
DrugPembrolizumab will be administered
Progression free survival (PFS) by BICR assessment
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
PFS by investigator assessment
PFS is defined as the time from the date of randomization to the date of first documented PD per RECIST 1.1 by investigator assessment or death from any cause, whichever occurs first
Objective response rate (ORR) by investigator assessment
ORR is defined as the percentage of participants with best overall response of either complete response (CR) or partial response (PR) per RECIST 1.1 by investigator assessment
ORR by BICR assessment
ORR is defined as the percentage of participants with best overall response of either CR or PR per RECIST 1.1 by BICR assessment
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GlaxoSmithKline
Lead sponsor
ENGOT, GOG, APGOT
Collaborator
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