NCT03283943

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Female
• Age: 19 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

It is postulated that focal sensitizing radiotherapy 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.

Detailed description

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.

Conditions

• Ovarian Cancer
• Primary Peritoneal Carcinoma
• Fallopian Tube Cancer

Interventions

Type	Name	Description
RADIATION	Focal radiotherapy	Focal sensitizing radiotherapy will be given at a starting dose level of 24 Gray (6 Gy X 4 fractions), and may be escalated to 32 Gy (8Gy X4 fractions).
DRUG	Durvalumab	Durvalumab 1500 mg IV every 28 days

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-12-16
• Completion: 2020-12-16
• First posted: 2017-09-15
• Last updated: 2018-07-11

Locations

1 site across 1 country: Canada