Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Me
Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers
| Condition(s) | Squamous Cell Carcinoma of Head and Neck |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers |
| Who can participate | Inclusion Criteria: 1. Patient must have signed a written informed consent form prior to any study specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent. 2. Histologically confirmed squamous cell carcinoma of head and neck (oral cavity, oropharynx, hypopharynx, and larynx) including unknown primary head and neck lymph nodes with distant metastases at presentation (T1-4 N0-3 M1). Histological confirmation is required in case of a single metastatic lesion. 3. Eligible for treatment by pembrolizumab according to the European Marketing Authorization 4. Patient ≥18 years old 5. Performance status: 0-1 (WHO) 6. Combined Positive Scor |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | UNICANCER |
| Locations | Avignon, France; Besançon, France; Bordeaux, France; Bordeaux, France; Caen, France; Carcassonne, France (+20 more sites) |
| Start date | 2021-12-01 |
| NCT ID | NCT04747054 |
| Official listing | https://clinicaltrials.gov/study/NCT04747054 |