Tecemotide (L-BLP25) in Prostate Cancer

Phase 2

Completed

Interventions: Radiation: Radiation therapy
Drug: Goserelin
Drug: Cyclophosphamide
Drug: Tecemotide (L-BLP25)

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard therapy plus tecemotide (L-BLP25)	Radiation therapy	Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
Standard therapy	Radiation therapy	Radiation therapy in combination with androgen deprivation therapy (ADT).
Standard therapy plus tecemotide (L-BLP25)	Tecemotide (L-BLP25)	Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
Standard therapy	Goserelin	Radiation therapy in combination with androgen deprivation therapy (ADT).
Standard therapy plus tecemotide (L-BLP25)	Goserelin	Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
Standard therapy plus tecemotide (L-BLP25)	Cyclophosphamide	Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)	Baseline and 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)	Baseline and 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

Name	Time	Method
Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels	From randomization up to 24 months	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)	Baseline, Week 6-12 (Pre-RT), Week 40 (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).