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Monoclonal Antibodies

Sacituzumab Tirumotecan + Pembrolizumab for Breast 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
Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
Has adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~77 months
Awards & highlights

Summary

"This trial is comparing a drug called sacituzumab tirumotecan alone and in combination with pembrolizumab to the standard treatment for patients with hormone receptor positive/human epider

Who is the study for?
This trial is for adults with HR+/HER2- advanced or metastatic breast cancer that's worsened after hormone therapy, including one with a CDK4/6 inhibitor. They should be able to undergo chemotherapy, have good physical function (ECOG 0-1), and controlled HIV if positive. Hepatitis B patients can join if treated for 4 weeks and virus undetectable; same for Hepatitis C with no detectable virus.
What is being tested?
The study tests Sacituzumab Tirumotecan alone and combined with Pembrolizumab against doctors' choice of treatment in participants. It aims to see which option better stops the cancer from progressing using standard criteria assessed by independent reviewers who don't know which treatment was given.
What are the potential side effects?
Possible side effects include reactions related to infusion, fatigue, nausea, low blood cell counts increasing infection risk or bleeding tendency, liver toxicity, hair loss from Paclitaxel or Nab-paclitaxel, skin reactions from Capecitabine and heart issues from Liposomal doxorubicin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer cannot be surgically removed, is HR+ and HER2-.
Select...
My organs are functioning well.
Select...
My HR+/HER2- breast cancer has worsened despite hormone therapy and a CDK4/6 inhibitor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~77 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~77 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
Secondary outcome measures
Change from baseline in diarrhea score, on the EORTC QLQ-C30
Change from baseline in emotional functioning score, on the EORTC QLQ-C30
Change from baseline in fatigue score, on the EORTC QLQ-C30
+13 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B:Pembrolizumab + Sacituzumab tirumotecanExperimental Treatment2 Interventions
Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to \~2 years).
Group II: Arm A: Sacituzumab tirumotecanExperimental Treatment1 Intervention
Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
Group III: Arm C: Treatment of Physician's Choice (TPC)Active Control4 Interventions
At the physician's discretion, participants receive chemotherapy of 80 mg/m\^2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m\^2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m\^2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m\^2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m\^2 of liposomal doxorubicin once every 4 weeks (Q4W) via IV infusion, until progressive disease or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,173,906 Total Patients Enrolled
59 Trials studying Breast Cancer
7,408 Patients Enrolled for Breast Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,078,580 Total Patients Enrolled
8 Trials studying Breast Cancer
5,963 Patients Enrolled for Breast Cancer
~800 spots leftby Jul 2027
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