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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Tecemotide (L-BLP25) in Prostate Cancer

NCTNCT01496131 (opens ClinicalTrials.gov in a new tab)Other idEMR 63325-015Other idBB-IND 7787
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
28 participants (actual)
Sponsor
EMD Serono · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
24 Oct 2011
Primary completion
25 Nov 2016
Completion
25 Nov 2016
First posted
21 Dec 2011 (estimated)
Last update posted
9 Mar 2018
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014201520162017
  1. Ph 2

    Tecemotide (L-BLP25) in Prostate Cancer

    NCT01496131

    24 Oct 2011 to 25 Nov 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Radiation therapyRadiation
  • GoserelinDrug
  • CyclophosphamideDrug
  • Tecemotide (L-BLP25)Drug

Arms2

  • Active comparator

    Standard therapy

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

  • Experimental

    Standard therapy plus tecemotide (L-BLP25)

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

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline and Day 60 (Pre-Radiation)

    Registry 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).

  2. Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)

    Time frame · Baseline and Day 190 (Post-radiation)

    Registry 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).

Secondary outcomes(2)

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

    Time frame · From randomization up to 24 months

    Registry 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.

  2. 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)

    Time frame · Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)

    Registry 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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 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 60 (Pre-Radiation)

GroupValue (Participants)
Standard Therapy2
Standard Therapy Plus Tecemotide (L-BLP25)3
Primary outcomeCount of participants· Baseline and Day 190 (Post-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)

GroupValue (Participants)
Standard Therapy1
Standard Therapy Plus Tecemotide (L-BLP25)1
Secondary and other outcome results(2)
Secondary outcomeCount of participants· From randomization up to 24 months

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

GroupValue (Participants)
Standard Therapy2
Standard Therapy Plus Tecemotide (L-BLP25)0
Secondary outcomeCount of participants· Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)

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)

GroupValue (Participants)
Standard Therapy1
Standard Therapy Plus Tecemotide (L-BLP25)1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Standard TherapySubjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.0 / 141 / 1414 / 14
Standard Therapy Plus Tecemotide (L-BLP25)Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.0 / 142 / 1414 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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