Tecemotide (L-BLP25) in Prostate Cancer

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01496131

BB-IND 7787 (Other Identifier)

EMR 63325-015

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Standard therapy

Active Comparator group

Description:

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

Treatment:

Drug: Goserelin

Radiation: Radiation therapy

Standard therapy plus tecemotide (L-BLP25)

Experimental group

Description:

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

Treatment:

Drug: Goserelin

Drug: Tecemotide (L-BLP25)

Drug: Cyclophosphamide

Radiation: Radiation therapy