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.

NCT02882308 ↗

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

EvaluationDrugModalityDoseRoute
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 —