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

ID#: NCT06132958

Age: 18 years - 66+

Gender: Female

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: December 06, 2023

End Date: January 10, 2028

Contact Information:
Toll Free Number
1-888-577-8839
Summary: 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 MK-2870 sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive MK-2870 sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.
Eligibility: The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 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
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