NCT02669914

MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors

A Phase II Study of MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Brain metastases are the most common intracranial malignancy occurring in 20-40% of all cancers, and the presence of CNS metastases is associated with a poor prognosis. As such, the median overall survival of patients with symptomatic brain lesions is a dismal 2-3 months regardless of tumor type. Because standard chemotherapy largely does not cross the blood brain barrier at a meaningful concentration, standard treatment is limited and usually involves surgical resection and/or stereotactic radiosurgery for isolated lesions and whole brain radiation for multiple lesions. Unfortunately, the median overall survival is only improved by about 6 months with this multimodality approach2, and there is a paucity of second-line therapies to treat recurrence. Furthermore, re-resection and re-radiation are often not feasible options due to concern for increasing complications or neurotoxicity, respectively. Thus, there is a dire clinical need for additional treatment options for this patient population. Checkpoint blockade therapy, in particular PD-1 and PD-L1 inhibition, has recently shown clinical efficacy in multiple types of solid tumors. The investigators propose to study the efficacy of checkpoint blockade therapy in patients with solid tumors and refractory/recurrent brain metastases. The investigators will assess the efficacy of MEDI4736, a novel PD-L1 inhibitory monoclonal antibody, in this study.

Conditions

• Non-Small Cell Lung Cancer
• Nonsmall Cell Lung Cancer
• Breast Cancer
• Cancer of Breast
• Cancer of the Breast
• Gastroesophageal Cancer
• Pancreatic Cancer
• Cancer of the Pancreas
• Colorectal Cancer
• Colorectal Carcinoma
• Renal Cancer
• Kidney Cancer
• Cancer of the Kidney
• Cancer of Kidney
• Ovarian Cancer
• Ovary Cancer
• Cancer of the Ovary
• Cancer of Ovary

Interventions

Type	Name	Description
DRUG	MEDI4736

Timeline

• Start date: 2016-09-12
• Primary completion: 2017-09-21
• Completion: 2018-01-11
• First posted: 2016-02-01
• Last updated: 2018-11-06
• Results posted: 2018-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study