Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments radiation therapy, goserelin, cyclophosphamide, tecemotide (l-blp25)
Phase phase 2
Sponsor EMD Serono
Collaborator National Cancer Institute (NCI)
Start date October 2011
End date October 2016
Trial size 28 participants
Trial identifier NCT01496131, BB-IND 7787, EMR 63325-015

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Radiation therapy in combination with androgen deprivation therapy (ADT).
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.
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.
(Experimental)
Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
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.
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.
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).
tecemotide (l-blp25) 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.

Primary Outcomes

Measure
Change from Baseline in the Enzyme-linked Immunosorbent Spot (ELISPOT) Level of Mucin-1 specific T-cells at 2 Months After Radiation
time frame: Baseline (Day -16 to -1) and Week 27 (approximately 2 months after radiation)
Change from Baseline in the ELISPOT Level of Mucin-1 specific T-cells at 6 Months After Radiation
time frame: Baseline (Day -16 to -1) and Week 40 (approximately 6 months after radiation)

Secondary Outcomes

Measure
Kaplan-Meier Estimates of Time to Disease Recurrence based on Prostate-specific antigen (PSA) Levels
time frame: Up to Month 24
Percentage of Subjects with a Doubling in Number of T-cells in tumor biopsy from Baseline to Week 27
time frame: Baseline (Day -16 to -1) to Week 27
Percentage of Subjects with a Doubling of Number of T-cells in tumor biopsy from Baseline to Week 40
time frame: Baseline (Day -16 to -1) to Week 40

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histopathologic documentation of prostate cancer confirmed at the institution of study enrollment prior to starting this study - Newly diagnosed or previously untreated prostate cancer with intermediate or high risk features as defined in the protocol - No evidence of metastatic disease on computed tomography (CT) / magnetic resonance imaging (MRI) or bone scans - No systemic steroid use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent intravenous contrast, allergic reaction or anaphylaxis (in subjects who have known contrast allergies) are allowed - Eastern Co-operative Oncology Group (ECOG) performance status of 0-1 - Human leukocyte antigen (HLA)-A2 or A3 positive for immunologic monitoring - Hematological and biochemical eligibility parameters as defined in the protocol - No other active malignancies within the past 3 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) - Willing to travel to the study center(s) for follow-up visits - Age greater than or equal to 18 years old - Able to understand and sign informed consent - Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 4 months after the last administration of immunotherapy Exclusion Criteria: - No evidence of being immunocompromised by human immunodeficiency virus, a medical condition requiring systemic steroids, a medical condition requiring immunosuppressive therapy, splenectomy - Active Hepatitis B or Hepatitis C - Subjects should have no autoimmune diseases that have required treatment as specified in the protocol - History of immunodeficiency diseases, hereditary or congenital immunodeficiencies - Serious intercurrent medical illness - A clinically significant cardiac disease - Subjects who have received any prior therapy for prostate cancer - Subjects who have known brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis - Subjects receiving any other investigational agents - Contraindication to biopsy such as bleeding disorders, ratio of prothrombin time to partial thromboplastin time (PT/PTT) >=1.5 times the upper limit of normal, artificial heart valve - Contraindication to MRI such as subjects weighing >136 kilograms, allergy to magnetic resonance (MR) contrast agent, subjects with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices - Contraindication to radiation therapy such as pre-existing and active prostatitis or proctitis, inflammatory bowel disease or known genetic sensitivity to ionizing radiation, or history of prior radiation to the pelvis

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by EMD Serono.