NCT02819518

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Official title

A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)

Phase

Phase 3

Status

Completed

Conditions

Triple Negative Breast Cancer (TNBC)

Interventions

Pembrolizumab; Nab-paclitaxel; Paclitaxel; Gemcitabine; Carboplatin; Normale Saline Solution

Arms

• Part 1: Pembrolizumab + Nab-paclitaxel · Experimental
• Part 1: Pembrolizumab + Paclitaxel · Experimental
• Part 1: Pembrolizumab + Gemcitabine/Carboplatin · Experimental
• Part 2: Pembrolizumab + Chemotherapy · Experimental
• Part 2: Placebo + Chemotherapy · Active comparator

Enrollment

882

Primary outcomes

• Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants
• Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants
• Part 2: Progression-Free Survival (PFS) - All Participants
• Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors
• Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors
• Part 2: Overall Survival (OS) - All Participants
• Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors
• Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors

Sponsor

Merck Sharp & Dohme LLC

Start

Jul 27, 2016

Primary completion

Jun 15, 2021

Results posted

Yes

Registry record

NCT02819518 · updated Nov 27, 2024

• Rugo HS, Cescon DW, Schmid P, Nowecki Z, Im SA, Md Yusof M, Gallardo C, Iwata H, Lipatov O, Cruz F, Barrios CH, Hegg R, Loi S, Gion M, Otero MT, Arkosy P, Tarnawski R, Yao L, Mejia J, Pan W, Cortes J. Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events. NPJ Breast Cancer. 2026 Jun 26. doi: 10.1038/s41523-026-00971-8. Online ahead of print. PubMed 42362563
• Im SA, Cortes J, Cescon DW, Yusof MM, Iwata H, Masuda N, Takano T, Huang CS, Chung CF, Tsugawa K, Park YH, Matsumoto K, Inoue K, Kwong A, Loi S, Fu W, Pan W, Karantza V, Rugo HS, Schmid P. Results from the randomized KEYNOTE-355 study of pembrolizumab plus chemotherapy for Asian patients with advanced TNBC. NPJ Breast Cancer. 2024 Sep 12;10(1):79. doi: 10.1038/s41523-024-00679-7. PubMed 39266535
• Cortes J, Rugo HS, Cescon DW, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Perez-Garcia J, Iwata H, Masuda N, Torregroza Otero M, Gokmen E, Loi S, Guo Z, Zhou X, Karantza V, Pan W, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2022 Jul 21;387(3):217-226. doi: 10.1056/NEJMoa2202809. PubMed 35857659
• Cortes J, Cescon DW, Rugo HS, Nowecki Z, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Holgado E, Iwata H, Masuda N, Otero MT, Gokmen E, Loi S, Guo Z, Zhao J, Aktan G, Karantza V, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020 Dec 5;396(10265):1817-1828. doi: 10.1016/S0140-6736(20)32531-9. PubMed 33278935