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Tecemotide (L-BLP25) in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation therapy
Goserelin
Cyclophosphamide
Tecemotide (L-BLP25)
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Tecemotide, Prostate Cancer, Goserelin, Cyclophosphamide, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Please Contact US Medical Information

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard therapy

Standard therapy plus tecemotide (L-BLP25)

Arm Description

Radiation therapy in combination with androgen deprivation therapy (ADT).

Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).

Outcomes

Primary Outcome Measures

Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)
MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).
Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)
MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).

Secondary Outcome Measures

Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels
Progression/recurrence status was reported based on Prostate-specific Antigen (PSA) Levels. Recurrence of PSA after completion of therapy represents disease progression and was determined using the American Society for Therapeutic Radiology and Oncology (ASTRO) "Phoenix criteria". These criteria define biochemical recurrence after radiation therapy as a PSA level equal to the lowest (nadir) PSA level achieved after therapy plus 2 nanogram per milliliter.
Number of Subjects With a Doubling in Number of T-cells in Tumor Biopsy From Baseline at Pre-radiotherapy (Pre-RT) and Post-radiotherapy (Post-RT)
Doubling in number of T-cells was assessed by immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies. Baseline was defined as the measurement taken within 8 weeks of prior to the first dose of study medication (Day 1).

Full Information

First Posted
November 3, 2011
Last Updated
February 9, 2018
Sponsor
EMD Serono
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01496131
Brief Title
Tecemotide (L-BLP25) in Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 24, 2011 (Actual)
Primary Completion Date
November 25, 2016 (Actual)
Study Completion Date
November 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Tecemotide, Prostate Cancer, Goserelin, Cyclophosphamide, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Radiation therapy in combination with androgen deprivation therapy (ADT).
Arm Title
Standard therapy plus tecemotide (L-BLP25)
Arm Type
Experimental
Arm Description
Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Goserelin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Tecemotide (L-BLP25)
Other Intervention Name(s)
L-BLP25, BLP25 liposome vaccine, Epipepimut-S
Intervention Description
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 Outcome Measure Information:
Title
Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)
Description
MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).
Time Frame
Baseline and Day 60 (Pre-Radiation)
Title
Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)
Description
MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).
Time Frame
Baseline and Day 190 (Post-radiation)
Secondary Outcome Measure Information:
Title
Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels
Description
Progression/recurrence status was reported based on Prostate-specific Antigen (PSA) Levels. Recurrence of PSA after completion of therapy represents disease progression and was determined using the American Society for Therapeutic Radiology and Oncology (ASTRO) "Phoenix criteria". These criteria define biochemical recurrence after radiation therapy as a PSA level equal to the lowest (nadir) PSA level achieved after therapy plus 2 nanogram per milliliter.
Time Frame
From randomization up to 24 months
Title
Number of Subjects With a Doubling in Number of T-cells in Tumor Biopsy From Baseline at Pre-radiotherapy (Pre-RT) and Post-radiotherapy (Post-RT)
Description
Doubling in number of T-cells was assessed by immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies. Baseline was defined as the measurement taken within 8 weeks of prior to the first dose of study medication (Day 1).
Time Frame
Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Please Contact US Medical Information
City
Rockland
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

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Tecemotide (L-BLP25) in Prostate Cancer

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