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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Endometrial Cancer

Treatments: Drug: Paclitaxel; Drug: Doxorubicin; Biological: Sacituzumab tirumotecan

Study type: Interventional

Funder types: NETWORK; Industry; Other

Identifiers

NCT06132958

jRCT2031240041 (Registry Identifier)

2023-504816-14 (Other Identifier)

U1111-1288-7581 (Other Identifier)

2870-005

Details and patient eligibility

About

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.

Enrollment: 710 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 180 days after completing platinum-based therapy administered in the curative-intent or adjuvant setting without any additional platinum-based therapy received in the metastatic or recurrent setting.
• Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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710 participants in 2 patient groups

Sacituzumab tirumotecan

Experimental group

Description:

Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Day 1 of each 14-day cycle. Additionally, participants receive diphenhydramine (or equivalent), a Histamine (H2 antagonist) of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.

Treatment:

Biological: Sacituzumab tirumotecan

Chemotherapy

Active Comparator group

Description:

Participants will receive 60 mg/m\^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m\^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle.

Treatment:

Drug: Doxorubicin

Drug: Paclitaxel