At a glance
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A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Cisplatin, and 3 other interventions for Recurrent Head and Neck Cancer and Metastatic Head and Neck Cancer. Completed, enrolled 882 participants.
Detailed Summary
Participants with recurrent or metastatic (R/M) squamous cell cancer of the head and neck (HNSCC) will be randomly assigned to receive pembrolizumab monotherapy \[pembro mono\], pembrolizumab plus chemotherapy with a platinum-based drug (cisplatin or carboplatin) and 5-Fluorouracil (5-FU) \[pembro combo\], or cetuximab plus a platinum-based drug (cisplatin or carboplatin) and 5-FU \[control\]. The overall primary study hypotheses are as follows in all participants and in participants with Programmed Cell Death Ligand 1 (PD-L1) positive expression defined by Combined Positive Score (CPS) ≥1 and CPS ≥20: 1) pembrolizumab monotherapy prolongs progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by Blinded Independent Central Review (BICR) and prolongs overall survival (OS) compared to standard treatment, and 2) pembrolizumab combination with chemotherapy prolongs PFS per RECIST 1.1 assessed by BICR and prolongs OS compared to standard treatment.
Study Details
Timeline
Interventions
Pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years).
Cisplatin 100 mg/m\^2 IV on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
Carboplatin at a target AUC 5 IV on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
Cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity