A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)

Summary

Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body.

Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells.

The goals of this study are to learn:

* About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and
* If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment

Conditions

• Cervical Cancer

Interventions

BIOLOGICAL

Pembrolizumab

Intravenous (IV) Infusion

BIOLOGICAL

Sacituzumab Tirumotecan

IV Infusion

BIOLOGICAL

Bevacizumab

IV Infusion

DRUG

Paclitaxel

IV Infusion

DRUG

Cisplatin

IV Infusion

DRUG

Carboplatin

IV Infusion

DRUG

Rescue Medications

Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).

Sponsors & Collaborators

• European Network of Gynaecological Oncological Trial Groups (ENGOT)

  collaborator OTHER

• 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

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-19

Primary Completion

2031-10-29

Completion

2031-10-29

FDA Drug

Yes

Countries

• United States
• Argentina
• Belgium
• Brazil
• Canada
• Chile
• Colombia
• Czechia
• Greece
• Hungary
• Israel
• Italy
• Japan
• Mexico
• Poland
• South Korea
• Spain
• Sweden
• Taiwan
• Thailand

Study Locations