Mapatumumab, Cisplatin and Radiotherapy for Advanced Cervical Cancer
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
Chemoradiotherapy has become the standard of care for women with locally advanced cervical
cancer. The available data support a 30 to 50% reduction in the risk of death from cervical
cancer for women with locally advanced disease undergoing radiotherapy (RT) and concomitant
cisplatin-based chemotherapy compared to RT alone. Despite the fact that this is currently
the best treatment of locally advanced cervical cancer, 5-year overall survival is still only
52%.
The fully human, agonist monoclonal antibody mapatumumab binds to the Tumor necrosis
factor-Related Apoptosis-Inducing Ligand Receptor 1 (TRAIL-R1, DR4) and induces cytotoxicity
in multiple tumor cell lines in vitro and in vivo. In multiple phase I and phase II studies,
mapatumumab appeared to be safe both as single agent and in combination with chemotherapy,
including cisplatin.
In cervical cancer cell lines, mapatumumab induced apoptosis in 51% of the cells. Mapatumumab
in combination with irradiation increased apoptosis to 83%.
In this phase 1b/2 study, the investigators will evaluate the safety, tolerability and
efficacy of mapatumumab in combination with cisplatin and radiotherapy in patients with
locally advanced cervical cancer.