Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

Running, not enrolling · Phase 3

Conditions studied: Endometrial Cancer

In brief

Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.

Key facts

Study ID

NCT06132958

Run by

Merck Sharp & Dohme LLC

People needed

710

Starts

2023-12-06

Expected to finish

2028-01-10

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
• Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
• Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.

You may not qualify if…

• Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
• Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
• Has had a recurrence of endometrial carcinoma or carcinosarcoma more than >12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
• Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
• Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
• Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
• Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
• Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
• Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization

Where it is running

• Sanford Health Roger Maris Cancer Center ( Site 4158) — Fargo, North Dakota, United States
• University of Cincinnati Medical Center ( Site 4136) — Cincinnati, Ohio, United States
• Sidney Kimmel Cancer Center - Jefferson Health ( Site 4157) — Philadelphia, Pennsylvania, United States
• AHN West Penn Hospital-Gynecologic Oncology ( Site 4111) — Pittsburgh, Pennsylvania, United States
• Asplundh Cancer Pavilion ( Site 4107) — Willow Grove, Pennsylvania, United States
• Women & Infants Hospital ( Site 4138) — Providence, Rhode Island, United States
• Sanford Cancer Center-Gynecologic Oncology ( Site 4121) — Sioux Falls, South Dakota, United States
• The West Clinic, PLLC dba West Cancer Center ( Site 4102) — Germantown, Tennessee, United States
• Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130) — Houston, Texas, United States
• Texas Oncology - San Antonio ( Site 8005) — San Antonio, Texas, United States
• Texas Oncology - Gulf Coast ( Site 8006) — The Woodlands, Texas, United States
• Hospital Británico de Buenos Aires-Oncology ( Site 1002) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008) — Buenos Aires, Buenos Aires F.D., Argentina
• Instituto Alexander Fleming-Alexander Fleming ( Site 1007) — Buenos Aires, Buenos Aires F.D., Argentina
• Hospital Aleman-Oncology ( Site 1001) — Buenos Aires, Argentina
• Instituto de Oncología Angel H. Roffo ( Site 1003) — Buenos Aires, Argentina
• Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1004) — Buenos Aires, Argentina
• Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006) — La Rioja, Argentina
• GenesisCare North Shore ( Site 1103) — St Leonards, New South Wales, Australia
• Blacktown Hospital ( Site 1101) — Sydney, New South Wales, Australia
• Royal Brisbane and Women's Hospital ( Site 1102) — Brisbane, Queensland, Australia
• Epworth Freemasons ( Site 1104) — East Melbourne, Victoria, Australia
• Frankston Hospital ( Site 1105) — Frankston, Victoria, Australia
• Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1201) — Innsbruck, Tyrol, Austria
• Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1902) — Helsinki, Uusimaa, Finland

Full record on ClinicalTrials.gov

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