Sacituzumab Tirumotecan + Pembrolizumab for Endometrial Cancer

(TroFuse-033 Trial)

Recruiting at 14 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Immunosuppressants, T-cell inhibitors

Disqualifiers: Sarcomas, dMMR, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 20

1123 Participants Needed

Trial Summary

What is the purpose of this trial?

Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for individuals with advanced or recurrent endometrial cancer that still has certain normal proteins (pMMR). Participants must have a confirmed diagnosis, measurable disease according to specific criteria, and no prior systemic therapy for their cancer except under certain conditions like one round of platinum-based chemotherapy or hormonal therapy discontinued at least a week before.

Inclusion Criteria

My endometrial cancer is advanced or recurrent and has normal mismatch repair function.

My cancer can be measured by scans and is in Stage III, IV, or is recurrent.

I have only had one prior platinum-based chemotherapy for endometrial carcinoma, or specific prior treatments as allowed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive pembrolizumab, carboplatin, and paclitaxel or docetaxel for 6 cycles

18 weeks

6 visits (in-person)

Maintenance Treatment

Participants receive pembrolizumab with or without sacituzumab tirumotecan for up to 14 cycles

19 months

14 visits (in-person)

Subsequent Treatment

Participants receive pembrolizumab with or without sacituzumab tirumotecan until discontinuation criteria are met

Up to 19 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 54 months

Treatment Details

Interventions

• Pembrolizumab
• Sacituzumab Tirumotecan

Trial Overview The study compares the effectiveness of Sacituzumab Tirumotecan (sac-TMT) combined with Pembrolizumab versus Pembrolizumab alone in prolonging life without worsening of pMMR endometrial cancer. Sac-TMT is an antibody drug conjugate targeting and destroying cancer cells.

Participant Groups

Group I: Subsequent Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan Experimental Treatment 5 Interventions

During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).

Group II: Maintenance Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan Experimental Treatment 5 Interventions

During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin area under the curve (AUC) 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).

Group III: Maintenance Treatment Arm B: Pembrolizumab Monotherapy Active Control 4 Interventions

During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).

Group IV: Subsequent Treatment Arm B: Sacituzumab Tirumotecan Monotherapy Active Control 4 Interventions

During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University