Abrogation of Chronic Monoclonal Antibody Treatment-induced T-cell Exhaustion With DURVALUMAB in Advanced HER-2 Negative Breast Cancer

• Status: Completed
• Trial end date: 2019-07-01

Summary

This is a single-arm pilot proof of concept, open-label clinical trial. Twenty-five subjects will be enrolled in 6 sites.

Metastatic breast cancer patients with disease progression to bevacizumab maintenance treatment will be potential candidates.

Bevacizumab maintenance will be considered as six weeks of bevacizumab treatment in monotherapy, with hormonal treatment or combined with chemotherapy in the context of previous bevacizumab plus chemotherapy regimens.

When progression to bevacizumab maintenance treatment occurs, patients will enter the trial and will start receiving DURVALUMAB 10 mg/kg Q2W IV infusion plus bevacizumab 10mg/kg IV infusion every 2 weeks. The patients will undergo a tumor biopsy before the first dose of DURVALUMAB, and after one month of combined treatment - the blood sampling will continue on a monthly basis. The treatment will continue until disease progression.

• Phase: Early Phase 1

Details

• Lead Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
• Collaborators: Fundación CRIS; Fundacion CRIS de Investigación para Vencer el Cáncer
• Treatments: Antibodies; Antibodies, Monoclonal; Bevacizumab; Durvalumab; Immunoglobulins