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Tecemotide (L-BLP25) in Prostate Cancer

NCT01496131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-03-09

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • EMD Serono

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-24
Primary Completion
2016-11-25
Completion
2016-11-25

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01496131 on ClinicalTrials.gov