HNSCC Clinical Trial
Official title:
A Phase III Randomized Trial of Avelumab-cetuximab-Radiotherapy Versus Standards of Care in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to demonstrate that treatment with avelumab in combination with RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab alone in terms of progression-free survival (PFS) in front-line patients with locally advanced SCCHN.
This open-label, randomized, controlled, multicenter phase III study will include 688 patients with LA SCCHN (420 fit for HD cisplatin and 268 unfit for HD cisplatin), histologically confirmed who had not received previous treatment for this setting. The study is designed with the primary objective of demonstrating that treatment with avelumab in combination with cetuximab-RT is superior to SOC Cisplatin-RT or cetuximab-RT alone in terms of PFS. Randomization will assign the 2 treatment arms of each cohort with a 1:1 ratio. In each cohort (fit for cisplatin and unfit for cisplatin), the randomization will be stratified for the 2 most established prognostic factors N stage (N0-N1 vs N2-3) and p16 expression (OPC p16+ versus OPC p16- or non OPC). All patients will be followed until death or at least 60 months. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Recruiting |
NCT04370587 -
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04114136 -
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
|
Phase 2 | |
Recruiting |
NCT05877430 -
Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03292250 -
Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]
|
Phase 2 | |
Completed |
NCT06446570 -
Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma
|
Phase 2 | |
Recruiting |
NCT05980000 -
Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma
|
Phase 2 | |
Recruiting |
NCT05581004 -
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT04606940 -
Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology (IO-KIN)
|
||
Recruiting |
NCT03356587 -
A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy
|
Phase 2 | |
Terminated |
NCT04272333 -
Intratumoral Microdosing of Motolimod in HNSCC
|
Early Phase 1 | |
Completed |
NCT03367780 -
Dose-Effect Relation of Salivary Gland Irradiation
|
||
Recruiting |
NCT04141449 -
A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation
|
Phase 2 | |
Recruiting |
NCT04157985 -
Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors
|
Phase 3 | |
Recruiting |
NCT05859074 -
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
|
Phase 1 | |
Recruiting |
NCT05814666 -
Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC
|
Phase 2 | |
Recruiting |
NCT04279509 -
Selecting Chemotherapy With High-throughput Drug Screen Assay Using Patient Derived Organoids in Patients With Refractory Solid Tumours (SCORE)
|
N/A | |
Recruiting |
NCT03526835 -
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Withdrawn |
NCT06090318 -
Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
|
Phase 1/Phase 2 | |
Completed |
NCT06366906 -
10-year Retrospective Study of Oral and Maxillofacial Squamous Cell Carcinoma
|