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

Breast Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Breast Cancer
  • Breast Neoplasms
  • Cancer of Breast
  • Cancer of Kidney
  • Cancer of Ovary
  • Cancer of the Breast
  • Cancer of the Kidney
  • Cancer of the Ovary
  • Cancer of the Pancreas
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Neoplasms
  • Gastroesophageal Cancer
  • Kidney Cancer
  • Kidney Neoplasms
  • Lung Neoplasms
  • Non-Small Cell Lung Cancer
  • Nonsmall Cell Lung Cancer
  • Ovarian Cancer
  • Ovarian Neoplasms
  • Ovary Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Renal Cancer
Clinical Trial Details
NCT number NCT02669914
Study type Interventional
Source Washington University School of Medicine
Contact
Status Terminated
Phase Phase 2
Start date September 12, 2016
Completion date January 11, 2018
View Details
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