The purpose of this study is to see how well mocertatug rezetecan (Mo-Rez) in combination with physician's choice of immunotherapy (dostarlimab or pembrolizumab) works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared with the physician's choice of immunotherapy (dostarlimab or pembrolizumab) alone, which represents the current standard of care. The study will also assess whether the drug combination is safe and tolerated well by participants compared to standard of 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 (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).
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
Mocertatug rezetecan
DrugMocertatug rezetecan 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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