Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 05 September 2018

The primary study hypothesis is that pembrolizumab or pembrolizumab in combination with chemotherapy prolongs progression free survival and overall survival compared to standard treatment.

purpose

Brief Summary:
Participants with recurrent or metastatic (R/M) squamous cell cancer of the head and neck (HNSCC) will be randomly assigned to receive pembrolizumab alone, or pembrolizumab + a platinum-based drug (cisplatin or carboplatin) + 5-Fluorouracil (5-FU), or cetuximab + a platinum-based drug (cisplatin or carboplatin) + 5-FU. The primary study hypothesis is that pembrolizumab or pembrolizumab in combination with chemotherapy prolongs progression free survival and overall survival compared to standard treatment.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Actual Study Start Date: March 19, 2015
Estimated Primary Completion Date: December 31, 2018
Estimated Study Completion Date: January 15, 2019

Arm:
- Experimental:
Pembrolizumab
- Experimental: Pembrolizumab + Platinum + 5-FU
- Active Comparator: Cetuximab + Platinum + 5FU

Category Value
Date last updated at source 23-Apr-18
Study type(s) Interventional
Expected enrolment 825
Study start date 19-Mar-15
Estimated primary completion date 31-Dec-18

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