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

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 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.

Conditions

• Endometrial Cancer

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

4 mg/kg of sacituzumab tirumotecan by IV infusion

DRUG

Doxorubicin

60 mg/m\^2 of doxorubicin by IV Infusion

DRUG

Paclitaxel

80 mg/m\^2 of paclitaxel by IV infusion

DRUG

Nab-paclitaxel

100 mg/m\^2 of nab-paclitaxel by IV infusion

DRUG

Rescue medications

Participants will receive the following rescue medications per approved product label before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).

Sponsors & Collaborators

• European Network for Gynaecological Oncological Trial groups(ENGOT)

  collaborator UNKNOWN

• GOG Foundation

  collaborator NETWORK

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-06

Primary Completion

2028-01-10

Completion

2028-01-10

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• Chile
• China
• Czechia
• Denmark
• Finland
• France
• Germany
• Greece
• Ireland
• Israel
• Italy
• Japan
• Malaysia
• Mexico
• Netherlands
• Norway
• Poland
• Puerto Rico
• Singapore
• South Korea
• Spain
• Sweden
• Switzerland
• United Kingdom

Study Locations