Clinical Trials Logo

Clinical Trial Summary

This study evaluate the regional (neck) nodal control of durvalumab in combination with RT restricted to the primary tumor and the immediately adjacent nodal level (i.e. without prophylactic neck irradiation) in N0 patients with SCCHN.


Clinical Trial Description

There is a strong rationale for testing this new paradigm of RT for SCCHN without prophylactic neck irradiation, being replaced by immune stimulation via the combination of RT and Programmed Death-1 (PD-L1) inhibition with durvalumab, due to: - The unmet medical need for new treatments, better tolerated and " as " or " more " effective than the current Standard Of Care (SOC) - The need to decrease radiation-induced toxicity, especially in fragile patients - The added toxicity due to elective nodal irradiation - The strong rationale to combine RT and PD-L1 inhibition - The potential immune suppressive effect of large field prophylactic neck irradiation It is hypothesized this innovative concept to be safe in the context of this study for the following reasons: - The rate of relapse in the neck is expected to be low in Magnetic Resonnance Imaging (MRI) & PET-CT N0 neck - A non-irradiated neck can be easily monitored, clinically and by imaging - Most of the potential relapses in the neck are expected to be salvaged by surgery and/or RT - The preventive irradiation of N0 regions is not anymore performed for others lymphophilic cancers (lymphoma, Non-Small Cell Lung Cancer (NSCLC)). The combination of durvalumab with RT restricted to the primary tumor site and immediate adjacent nodal area will achieve a similarly regional (nodal) control rate than standard RT including large prophylactic neck irradiation (regional recurrence < 10 %. This study will include patients with early (T1-T2 N0) or locally advanced SCCHN (T3-4 N0), histologically proven who had not received previous treatment for this setting. The study is designed with the primary objective of demonstrating that RT without large prophylactic irradiation in combination with durvalumab is effective in terms of regional control. All patients will be followed until death or at least 36 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03726775
Study type Interventional
Source Groupe Oncologie Radiotherapie Tete et Cou
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 17, 2019
Completion date August 2026

See also
  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
Active, not recruiting NCT02999087 - Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH) Phase 3
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
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
Active, not recruiting NCT03719690 - Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy Phase 2
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