drugset / Trial / NCT02882308
Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.
RandomizedFactorialOpen-labelTreatment
Summary
OPHELIA (OPHELIA (OlaParib and durvalumab in HEad and neck squamous celL carcInomA) trial is a Greek, investigator-initiated, randomized open-label window-of-opportunity phase II study. Patients with operable histologically documented squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx will be randomized between combination with durvalumab and olaparib, cisplatin and olaparib, monotherapy with olaparib or no treatment, before starting standard treatment.
Timeline
- Start
- 2016-10-20
- Primary completion
- 2019-12
- Completion
- 2020-01-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | — |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | — |
| Subject | Olaparib | Small molecule | 25 mg | — |
| Subject | Olaparib | Small molecule | 50 mg | — |
| Subject | Olaparib | Small molecule | 300 mg | — |