Pembrolizumab for PD-L1 Positive

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Texas MD Anderson Cancer Center, Houston, TX
PD-L1 Positive+3 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Eligible Conditions

  • PD-L1 Positive
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for PD-L1 Positive

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Randomization up to approximately 53 months

Month 53
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Month 33
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Month 53
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Overall Survival (OS)
TTD of Fatigue Score as Measured by EORTC QLQ-C30
TTD of Pain Score as Measured by EORTC QLQ-C30
TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30
TTD of Role Functioning Score as Measured by EORTC QLQ-C30
Time to Deterioration (TTD) in Global Health Status/Quality of Life (QoL) Scale as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30)
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for PD-L1 Positive

Trial Design

2 Treatment Groups

Pembrolizumab + Treatment of Physician's Choice (TPC)
1 of 2
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab
1 of 2
Active Control
Experimental Treatment

440 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 3

Sacituzumab Govitecan-hziy (SG) + PembrolizumabExperimental Group · 2 Interventions: Sacituzumab Govitecan-hziy, Pembrolizumab · Intervention Types: Drug, Drug
Pembrolizumab + Treatment of Physician's Choice (TPC)ActiveComparator Group · 5 Interventions: nab-Paclitaxel, Pembrolizumab, Gemcitabine, Paclitaxel, Carboplatin · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: randomization up to approximately 53 months
Closest Location: University of Texas MD Anderson Cancer Center · Houston, TX
Photo of the university of texas md anderson cancer center 1Photo of the university of texas md anderson cancer center 2Photo of the university of texas md anderson cancer center 3
2020First Recorded Clinical Trial
1 TrialsResearching PD-L1 Positive
732 CompletedClinical Trials

Who is running the clinical trial?

Gilead SciencesLead Sponsor
999 Previous Clinical Trials
657,064 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,626 Previous Clinical Trials
4,947,988 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
314 Previous Clinical Trials
176,222 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of childbearing potential and you engage in heterosexual intercourse
You are on ART and have a well-controlled HIV infection/disease.
You have locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) and you have not received previous systemic therapy for advanced disease
You are eligible for this study if you have TNBC and have not received prior chemotherapy for metastatic disease.
You have measurable disease by CT or MRI as per RECIST criteria as evaluated locally.
Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
TNBC status and tumor PD-L1 CPS will be confirmed centrally on a recent or archival tumor specimen.
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.