Clinical Trial: NCT02819518
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2024-11-27 |
Study Overview
Brief Summary
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 background chemotherapy will be assessed compared to the safety and efficacy of placebo plus background 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.
Official Title
Conditions
Intervention / Treatment
- Biological: Pembrolizumab
- Drug: Nab-paclitaxel
- Drug: Paclitaxel
- Drug: Gemcitabine
- Drug: Carboplatin
- Drug: Normale Saline Solution
Other Study ID Numbers
- 3475-355
- 163422
- MK-3475-355
- KEYNOTE-355
- 2016-001432-35
- 2016
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2024-11-27 |
Study Overview
Brief Summary
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 background chemotherapy will be assessed compared to the safety and efficacy of placebo plus background 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.
Official Title
Conditions
Intervention / Treatment
- Biological: Pembrolizumab
- Drug: Nab-paclitaxel
- Drug: Paclitaxel
- Drug: Gemcitabine
- Drug: Carboplatin
- Drug: Normale Saline Solution
Other Study ID Numbers
- 3475-355
- 163422
- MK-3475-355
- KEYNOTE-355
- 2016-001432-35
- 2016