NCT02303366

Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475

A Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, observational pilot study that will describe the safety profile and biological effects of combining stereotactic ablative body radiosurgery (SABR) treatment (20Gy/1#) and a PD-1 antibody, MK-3475. 15 patients with oligometastatic breast cancer with at least one lesion considered safe for SABR radiotherapy, will be treated with SABR for their oligometatastic disease in addition to 6 months of MK-3475 treatment (1 cycle every 3 weeks, a total of 8 cycles). This investigator driven pilot study will examine the safety and biological effects of combining MK-3475 (Pembrolizumab) an antibody targeted against the anti-programmed cell death 1 (PD-1) T cell checkpoint, with SABR therapy for oligometastatic disease. We hypothesise that the safety profile of this combination, will be clinically acceptable and well tolerated for patients, and that we will observe evidence of systemic immune activation.

Conditions

• Breast Neoplasms
• Bone Neoplasms

Interventions

Type	Name	Description
RADIATION	Stereotactic Ablative Body Radiosurgery (SABR)	Stereotactic Ablative Body Radiosurgery (SABR) - a single 20Gy in 1 fraction.
DRUG	MK-3475	MK-3475 (200mg IV) on day 1 every 3 weeks for a total of 8 cycles.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2014-11-27
• Last updated: 2017-10-18

Locations

1 site across 1 country: Australia