At a glance
ClinicalIndex Comparison Record- ✓Histologically and/or cytologically confirmed malignant pleural mesothelioma
- ✓Unresectable disease (not a candidate for curative surgery)
- ✓Measurable disease with at least 1 lesion suitable for assessment by CT or MRI (modified RECIST for pleural mesothelioma)
- ✓Available unstained archived tumor tissue: at least 15 unstained slides or tumor block (core or surgical biopsy required, fine needle aspiration insufficient)
- ✕Prior systemic therapy for mesothelioma (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, monoclonal antibodies, or investigational agents)
- ✕Prior or concurrent PD-1 or PD-L1 inhibitors (including durvalumab or other immune checkpoint inhibitors)
- ✕Non-pleural mesothelioma (peritoneal, tunica vaginalis, or other serosal surfaces)
- ✕Active second malignancy (except non-melanoma skin cancer or cervical carcinoma in situ)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Label, Phase II Study of Anti - Programmed Death - Ligand 1 Antibody, Durvalumab (MEDI4736), in Combination With Chemotherapy for the First-Line Treatment of Unresectable Mesothelioma
In Brief
A Phase 2 clinical trial evaluating Durvalumab for Mesothelioma and Pleural Mesothelioma. Completed, enrolled 55 participants across 20 sites.
Detailed Summary
Patients with pleural mesothelioma that can not be surgically removed will receive durvalumab, in combination with standard chemotherapy of pemetrexed and cisplatin as first-line treatment. Durvalumab is a type of drug called a monoclonal antibody (a type of protein). Laboratory tests show that it works by allowing the immune system to detect your cancer and reactivates the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS).
Study Details
Timeline
Interventions
On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV will be administered before pemetrexed and cisplatin chemotherapy over approximately 60 minutes. Approximately 30 minutes after the durvalumab infusion is complete, pemetrexed 500 mg/m² IV will be administered over 10 minutes. Cisplatin 75 mg/m² IV over 2 hours will begin approximately 30 minutes after the end of pemetrexed administration. If carboplatin is substituted for cisplatin, carboplatin Area Under the Concentration-Time Curve (AUC) 5 will be infused over 30 minutes beginning approximately 15-30 minutes after the end of the pemetrexed administration. Maintenance: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV over approximately 60 minutes.