Recurrent Head and Neck Cancer Clinical Trial
Official title:
A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
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.
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). ;
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 | |
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 | |
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 |
NCT01255800 -
Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer
|
Phase 1 |