Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The 12 primary superiority hypotheses will be evaluated by comparing the pembro mono arm or pembro combo arm separately to the control arm, for PFS and OS in all first line (1L) R/M HNSCC participants and in 1L R/M HNSCC participants with positive PD-L1 expression (PD-L1 CPS ≥1 and CPS ≥20). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02358031
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Completed
Phase Phase 3
Start date March 19, 2015
Completion date July 18, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05738187 - Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study N/A
Recruiting NCT02567383 - Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer Phase 2
Recruiting NCT05980000 - Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma Phase 2
Active, not recruiting NCT03691714 - Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 2
Terminated NCT02842125 - Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Terminated NCT04969861 - BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36) Phase 2/Phase 3
Active, not recruiting NCT04260126 - Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC Phase 2
Completed NCT02422979 - Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer Phase 1/Phase 2
Completed NCT04902027 - A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers Phase 1
Recruiting NCT04534205 - A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 Phase 2
Active, not recruiting NCT02289209 - Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck Phase 2
Recruiting NCT06239220 - PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC Phase 2
Recruiting NCT04673929 - Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract
Recruiting NCT03754933 - Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer Phase 1/Phase 2
Terminated NCT03937141 - Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer Phase 2
Terminated NCT00088907 - Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer Phase 3
Terminated NCT01606566 - A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer. Phase 2
Completed NCT01620242 - A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes Phase 2
Completed NCT01255800 - Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer Phase 1