PDL-1 Inhibition and Focal Sensitizing Radiation Therapy in Recurrent Ovarian/Primary Peritoneal/Fallopian Tube Cancers.

Titre officiel

Phase I (Safety Assessment) of Durvalumab (MEDI4736) With Focal Sensitizing Radiation Therapy in Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Epithelial Carcinoma

Sommaire:

It is postulated that focal sensitizing radiation therapy may potentiate the effectiveness of durvalumab. The purpose of this study is to test the safety and tolerability of 2 different dose levels of focal sensitizing radiation therapy given with durvalumab.

Description de l'essai

Primary Outcome:

  • Determine the maximum tolerated dose of durvalumab combined with focal irradiation for use in recurrent ovarian cancer
Secondary Outcome:
  • Objective response rate
  • CA-125 response rate
  • Immune-related response rate
Durvalumab is a PDL-1 inhibitor, part of class of agents (called checkpoint inhibitors) designed to increase the ability of the immune system to recognize and work to eliminate cancers. Checkpoint inhibitors have been studied in recurrent ovarian, primary peritoneal and Fallopian cancers, and on their own show a low level of activity. Radiation therapy is usually used in women with recurrent ovarian, primary peritoneal and Fallopian cancers to palliate symptoms related to progressive disease. However, radiation is know to modify the cancer immune environment and to release tumour antigens. These actions may potentiate the function of immune checkpoint inhibitors.

Voir cet essai sur ClinicalTrials.gov

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