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Anti-tumor antibiotic

Sacituzumab Tirumotecan for Endometrial Cancer (TroFuse-005 Trial)

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The main inclusion

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares MK-2870 to Treatment of Physician's Choice (TPC) to see if MK-2870 is better at progression-free survival & overall survival.

Who is the study for?

This trial is for individuals with endometrial cancer who have already undergone treatment with platinum-based chemotherapy and immunotherapy but need additional treatment. Participants should meet specific health criteria as determined by the study's guidelines.

What is being tested?

The study aims to compare a new medication, MK-2870, against treatments that doctors usually choose (TPC) in terms of how long patients live without their cancer getting worse and overall survival rates.

What are the potential side effects?

Possible side effects of MK-2870, Paclitaxel, and Doxorubicin include nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, heart problems, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30])

Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

Number of Participants Who Discontinue Study Intervention Due to an AE

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sacituzumab tirumotecanExperimental Treatment1 Intervention

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.

Group II: ChemotherapyActive Control2 Interventions

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.

0 / 1Eligibility criteria met