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A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
1123 patients around the world
Available in Puerto Rico, Argentina, United States
All participants undergo an initial Induction Phase of six cycles, each cycle consisting
of pembrolizumab + carboplatin + paclitaxel or docetaxel. Each cycle is three weeks.
Participants whose cancer does not progress enter the Maintenance Treatment Phase and are
then randomly assigned to pembrolizumab + sac-TMT or pembrolizumab monotherapy.
Participants whose cancer does progress will have the possibility to enter the Subsequent
Treatment Phase and are then randomly assigned to pembrolizumab + sac-TMT or sac-TMT
monotherapy.
Merck Sharp & Dohme LLC
1Research sites
1123Patients around the world
This study is for people with
Endometrial Cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR).Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment.
- Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas.Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR).Is a candidate for curative-intent surgery or curative-intent radiotherapy at the time of enrollment.Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
StudyTroFuse-033
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Endometrial Cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT06952504
