Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors
Trial Parameters
Brief Summary
This is a phase 2 study of the combination of drugs olaparib and durvalumab for the treatment of isocitrate dehydrogenase or (IDH) mutated solid tumors. The purpose of this study is to assess the efficacy of the drug combination via overall response rate and overall disease control rate. It is believed that giving olaparib and durvalumab together would be more useful when given to patients with IDH-mutated solid tumors than giving each drug alone.
Eligibility Criteria
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Must be ≥ 18 years. * Body weight \> 30 kg. * For Cohort A: Patients must have histologically or cytologically confirmed diffuse astrocytic and oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant. They must have not received more than 2 regimens of systemic therapy after initial relapse. * For Cohort B: Patients must have histologically or cytologically confirmed adenocarcinoma of the biliary tract which are IDH mutant. They must have not received more than 2 regimens of systemic therapy for advanced disease. * Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Patients must have a life expectancy ≥ 16 weeks. * All participants must agree to use methods to prevent pregnancy as agreed upon between the participant