Keynote 355
The study will consist of two parts.
In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has not been previously treated with chemotherapy.
In Part 2, the safety and efficacy of pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy.
The primary hypotheses are that:
the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in:
all participants,
participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 tumors, and
participants with PD-L1 CPS ≥10 tumors, and
the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS) compared to placebo and chemotherapy in:
all participants,
participants with PD-L1 CPS ≥1 tumors, and
participants with PD-L1 CPS ≥10 tumors.
CLINICALTRIALS.GOV IDENTIFIER:
NCT02819518
When speaking to your doctor, please have the trial identifier number available.
All patients who enroll in the trial will receive medication while on the study.
67% will receive pembrolizumab along with chemotherapy
33% will receive placebo along with chemotherapy
*You will be assigned by chance (a process called randomization) to receive one of the above treatments. Please note the above information relates to Part 2 of the study.
Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices.
Dates
Conditions
Triple Negative Breast Cancer
Age Range
18 - No Age Maximum
Sex
All
Sorry, this trial does not have any locations currently. Please check back later.
If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.
Print this page or email it to your doctor to discuss at your next visit.
CLINICALTRIALS.GOV IDENTIFIER:
NCT02819518
When speaking to your doctor, please have the trial identifier number available.
Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.
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