Tecemotide (L-BLP25) in Prostate Cancer

NCT01496131 | Completed Phase 2 Results

• 2 other identifiers: EMR 63325-015BB-IND 7787
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Tecemotide; Prostate Cancer; Goserelin; Cyclophosphamide; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline and Day 60 (Pre-Radiation)

• 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).

  Baseline and Day 190 (Post-radiation)

Secondary Outcomes (2)

• Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels

  From randomization up to 24 months

• 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)

Study Arms (2)

Standard therapy

ACTIVE COMPARATOR

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

Radiation: Radiation therapy; Drug: Goserelin

Standard therapy plus tecemotide (L-BLP25)

EXPERIMENTAL

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

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

Interventions

Radiation therapy RADIATION

Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.

Standard therapy; Standard therapy plus tecemotide (L-BLP25)

Goserelin DRUG

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.

Standard therapy; Standard therapy plus tecemotide (L-BLP25)

Cyclophosphamide DRUG

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).

Standard therapy plus tecemotide (L-BLP25)

Tecemotide (L-BLP25) DRUG

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.

Also known as: L-BLP25, BLP25 liposome vaccine, Epipepimut-S

Standard therapy plus tecemotide (L-BLP25)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Please Contact US Medical Information

Rockland, Massachusetts, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Goserelin; Cyclophosphamide; L-BLP25

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Limitations and Caveats

For primary outcome measure, antigen specific data was provided with updated technique. Enzyme-Linked ImmunoSpot technique was not done, but intracellular cytokine antigen specific responses was evaluated, which is now the lab technique used.

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: December 21, 2011
• Study Start: October 24, 2011
• Primary Completion: November 25, 2016
• Study Completion: November 25, 2016
• Last Updated: March 9, 2018
• Results First Posted: March 9, 2018

Record last verified: 2018-02

Locations

US (1)