NCT02707588View on ClinicalTrials.gov

Tolerance and Efficacy of Pembrolizumab or Cetuximab Combined With RT in Patients With Locally Advanced HNSCC

PHASE2CompletedINTERVENTIONAL
Enrollment

133

Participants

Timeline

Start Date

May 18, 2016

Primary Completion Date

October 31, 2022

Study Completion Date

October 17, 2022

Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG

Pembrolizumab

"200mg IV infusion every 3 weeks, i.e. on day 1, 22, 43 during the course of radiotherapy.~Radiotherapy will be delivered daily for 5 days per week to a total dose of 69.96 Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions)."

DRUG

Cetuximab

"Loading dose of 400 mg/m² IV on Day-8, followed by weekly dose of 250 mg/m² IV during the whole course of radiotherapy.~Radiotherapy will be delivered daily for 5 days per week to a total dose of 69.96 Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions)."

RADIATION

Radiotherapy

Radiotherapy will be delivered daily for 5 days per week to a total dose of 69.96 Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions).

Trial Locations (1)

76000

Centre Guillaume le conquérant, Le Havre

All Listed Sponsors
lead

Groupe Oncologie Radiotherapie Tete et Cou

OTHER

NCT02707588 - Tolerance and Efficacy of Pembrolizumab or Cetuximab Combined With RT in Patients With Locally Advanced HNSCC | Biotech Hunter | Biotech Hunter