Tecemotide (L-BLP25) in Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by EMD Serono
Sponsor:
Collaborator:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01496131
First received: November 3, 2011
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Radiation: Radiation therapy
Drug: Goserelin
Drug: Cyclophosphamide
Drug: Tecemotide (L-BLP25)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    To determine impact of tecemotide (L-BLP25) immunotherapy in addition to standard treatment on the mucinous glycoprotein 1 (MUC1) specific systemic immune response in subjects with untreated, intermediate and high risk prostate cancer tecemotide (L-BLP25) immunotherapy in combination with Androgen Deprivation Therapy (ADT) and radiation therapy.

  • 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) ] [ Designated as safety issue: No ]
    To determine impact of tecemotide (L-BLP25) immunotherapy in addition to standard treatment on the MUC1 specific systemic immune response in subjects with untreated, intermediate and high risk prostate cancer tecemotide (L-BLP25) immunotherapy in combination with ADT and radiation therapy.


Secondary Outcome Measures:
  • Kaplan-Meier Estimates of Time to Disease Recurrence based on Prostate-specific antigen (PSA) Levels [ Time Frame: Up to Month 24 ] [ Designated as safety issue: No ]
    To evaluate progression/recurrence status up to 24 months after randomization in subjects receiving tecemotide (L-BLP25) immunotherapy in combination with the standard treatment versus subjects receiving standard treatment alone.

  • 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 ] [ Designated as safety issue: No ]
    To analyze immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies.

  • 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 ] [ Designated as safety issue: No ]
    To analyze immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies.


Estimated Enrollment: 48
Study Start Date: October 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard therapy
Radiation therapy in combination with androgen deprivation therapy (ADT).
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.
Experimental: Standard therapy plus tecemotide (L-BLP25)
Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
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.
Other Names:
  • L-BLP25
  • BLP25 liposome vaccine
  • Epipepimut-S

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496131

Contacts
Contact: US Medical Information 888-275-7376

Locations
United States, Massachusetts
Please Contact US Medical Information Recruiting
Rockland, Massachusetts, United States
Contact    888-275-7376      
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01496131     History of Changes
Other Study ID Numbers: EMR 63325-015, BB-IND 7787
Study First Received: November 3, 2011
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Tecemotide
Prostate Cancer
Goserelin
Cyclophosphamide
Radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cyclophosphamide
Goserelin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on August 25, 2014