drugset / Trial / NCT03088059
Biomarker-based Study in R/M SCCHN
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts.
Timeline
- Start
- 2017-11-16
- Primary completion
- 2025-06
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | 40 mg | Oral |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Monalizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Monalizumab | Monoclonal antibody | 750 mg | Intravenous |
| Subject | Niraparib | Small molecule | 300 mg | Oral |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |
| Subject | RAGIFILIMAB | Monoclonal antibody | 300 mg | Intravenous |
| Background | Bleomycine | Unknown | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Mitomycine | Unknown | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |