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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 Mexico, Puerto Rico, Argentina, United States, Belgium, Spain, Brazil, Chile, Colombia, Peru
All participants undergo an initial Induction Phase of six cycles, each cycle consisting of pembrolizumab + carboplatin or cisplatin + 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
26Research 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 debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following 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
Site Pen
Recruiting
Instituto San Marcos Investigación - San Juan
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Fundación Respirar
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de Controle do Cancer - IBC
Recruiting
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
StudyTroFuse-033
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Endometrial Cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT06952504
