NCT01496131

Tecemotide (L-BLP25) in Prostate Cancer

A Randomized Phase II Study of Tecemotide in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Untreated, Intermediate and High Risk Prostate Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: EMD Serono · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Radiation therapy	Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.
DRUG	Goserelin	ADT (Goserelin) will be administered at a dose of 10.8 milligrams (mg) subcutaneously every 3 months for 24 months for the high risk group and for 6 months in the intermediate risk group, starting 2-3 months prior to radiation therapy.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered at a single dose of 300 milligrams per square meter (mg/m\^2) to a maximum of 600 mg, as an intravenous injection 3 days prior to the first administration of tecemotide (L-BLP25).
DRUG	Tecemotide (L-BLP25)	Tecemotide (L-BLP25) will be administered at a dose of 918 microgram (mcg) as subcutaneous injection every 2 weeks for 5 doses followed by every 6 weeks for an additional 4 doses, starting 2-3 months prior to radiation therapy and on the same day that ADT began.

Timeline

• Start date: 2011-10-24
• Primary completion: 2016-11-25
• Completion: 2016-11-25
• First posted: 2011-12-21
• Last updated: 2018-03-09
• Results posted: 2018-03-09

Locations

1 site across 1 country: United States