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Anti-tumor antibiotic

Sacituzumab tirumotecan for Endometrial Cancer

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Find a Location

Who is running the clinical trial?

European Network for Gynaecological Oncological Trial groups(ENGOT)UNKNOWN

GOG FoundationNETWORK

42 Previous Clinical Trials

16,031 Total Patients Enrolled

3 Trials studying Endometrial Cancer

788 Patients Enrolled for Endometrial Cancer

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,436 Total Patients Enrolled

19 Trials studying Endometrial Cancer

3,433 Patients Enrolled for Endometrial Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What implications does MK-2870 have for the health of trial participants?

"The safety of MK-2870 has been rated a 3, given the evidence backing its efficacy and data collected during multiple rounds confirming its safety."

Answered by AI

Is there still an opportunity for individuals to join this experiment?

"Information listed on clinicaltrials.gov reveals that this study is not currently recruiting participants, having first been posted on December 12th 2023 and last updated six days prior to the present date. Nonetheless, there are 316 other medical trials presently seeking volunteers."

Answered by AI

What aims are being pursued through this research endeavor?

"The primary efficacy endpoint of this longitudinal clinical trial is Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR), which will be evaluated over a period up to four years. Auxiliary objectives encompass recording the Number of Participants Who Experience One or More Adverse Events, tracking those who Discontinue Study Intervention Due to an AE and Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR details for participants demonstrating confirmed CR or PR per RECIST 1.1"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132958.