Pembrolizumab for Triple Negative Breast Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Triple Negative Breast Neoplasms+1 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment involving two drugs. It will study the side effects and if the drugs are effective in treating triple-negative breast cancer.

Eligible Conditions
  • Triple Negative Breast Neoplasms

Treatment Effectiveness

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Up to 18 weeks following last dose; approximately 1 year

Month 10
Incidence of adverse events
Incidence of dose-limiting toxicities
Incidence of laboratory abnormalities
Year 1
Confirmed objective response rate
Year 5
Disease control rate
Duration of response
Overall survival
Progression-free survival

Trial Safety

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

2 Treatment Groups

LV plus pembrolizumab
1 of 2
LV + pembrolizumab
1 of 2

Experimental Treatment

211 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1 & 2

LV plus pembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, ladiratuzumab vedotin · Intervention Types: Drug, Drug
LV + pembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, ladiratuzumab vedotin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 18 weeks following last dose; approximately 1 year

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,656 Previous Clinical Trials
4,953,947 Total Patients Enrolled
49 Trials studying Triple Negative Breast Neoplasms
8,500 Patients Enrolled for Triple Negative Breast Neoplasms
Seagen Inc.Lead Sponsor
183 Previous Clinical Trials
61,563 Total Patients Enrolled
5 Trials studying Triple Negative Breast Neoplasms
1,815 Patients Enrolled for Triple Negative Breast Neoplasms
Zejing Wang, MD, PhDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
712 Total Patients Enrolled
1 Trials studying Triple Negative Breast Neoplasms
448 Patients Enrolled for Triple Negative Breast Neoplasms
Sinhan Tran, PharmD, MBAStudy DirectorSeagen Inc.
2 Previous Clinical Trials
712 Total Patients Enrolled
1 Trials studying Triple Negative Breast Neoplasms
448 Patients Enrolled for Triple Negative Breast Neoplasms
Kristel Apolinario, PharmDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
448 Total Patients Enrolled
1 Trials studying Triple Negative Breast Neoplasms
448 Patients Enrolled for Triple Negative Breast Neoplasms
Brandon Croft, PharmDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
712 Total Patients Enrolled
1 Trials studying Triple Negative Breast Neoplasms
448 Patients Enrolled for Triple Negative Breast Neoplasms

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not received curative intent treatment for a recurrence of the disease.
Tumor tissue PD-L1 Combined Positive Score <10 expression.
You have at least 1 tumor 10mm in diameter or greater or lymph node of at least 15 mm in short axis.
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.