CompletedNCT01496131Updated Mar 9, 2018Results posted

Tecemotide (L-BLP25) in Prostate Cancer

A Phase 2 interventional study of Radiation therapy and Goserelin in Prostate Cancer, sponsored by EMD Serono. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.

Sponsored by EMD Serono · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 28
Allocation: Randomized
Ages: 18 Years and older
Sex: Male

Study summary

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

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,370

Keywords

Tecemotide
Prostate Cancer
Goserelin
Cyclophosphamide
Radiotherapy

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 28 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

EMD Serono is the lead sponsor of 88 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 28 participants (actual)

Study arms

Active comparator
Standard therapy
Radiation therapy in combination with androgen deprivation therapy (ADT).
Radiation: Radiation therapy · Drug: Goserelin
Experimental
Standard therapy plus tecemotide (L-BLP25)
Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
Radiation: Radiation therapy · Drug: Goserelin · Drug: Cyclophosphamide · Drug: Tecemotide (L-BLP25)

Interventions

RadiationRadiation therapy
Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.
DrugGoserelin
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.
DrugCyclophosphamide
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).
DrugTecemotide (L-BLP25)
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

What researchers measure

Primary outcomes

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).
Time frame: 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).
Time frame: Baseline and Day 190 (Post-radiation)

Secondary outcomes

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.
Time frame: 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)
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)

Results

Posted Mar 9, 2018

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.

Participant flow

First subject First Visit/Last Subject Last Visit: 24 October 2011/25 November 2016.

Participant flow — Overall Study
Milestone	Standard Therapy	Standard Therapy Plus Tecemotide (L-BLP25)
Started	14	14
Completed	14	14
Not completed	0	0

Outcome measures

PrimaryNumber 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).

Time frame:: Baseline and Day 60 (Pre-Radiation)
Reported as:: Count of participants · Participants

Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)
Participants	Standard Therapy	Standard Therapy Plus Tecemotide (L-BLP25)
Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)	2	3

PrimaryNumber 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)
Reported as:: Count of participants · Participants

Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)
Participants	Standard Therapy	Standard Therapy Plus Tecemotide (L-BLP25)
Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)	1	1

SecondaryNumber 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.

Time frame:: From randomization up to 24 months
Reported as:: Count of participants · Participants

Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels
Participants	Standard Therapy	Standard Therapy Plus Tecemotide (L-BLP25)
Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels	2	0

SecondaryNumber 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).

Time frame:: Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)
Reported as:: Count of participants · Participants

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)
Participants	Standard Therapy	Standard Therapy Plus Tecemotide (L-BLP25)
Pre-RT	1	1
Post-RT	—	1

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Standard Therapy	0/14 (0%)	1/14 (7.1%)	14/14 (100%)
Standard Therapy Plus Tecemotide (L-BLP25)	0/14 (0%)	2/14 (14.3%)	14/14 (100%)

Most frequent serious events

Most frequent serious events
Event	Standard Therapy	Standard Therapy Plus Tecemotide (L-BLP25)
Abdominal painGastrointestinal disorders	0/14	1/14
DiarrhoeaGastrointestinal disorders	0/14	1/14
Crohn's diseaseGastrointestinal disorders	0/14	1/14
Small intestinal obstructionGastrointestinal disorders	0/14	1/14
Osteoarthritis;hip replacement surgeryMusculoskeletal and connective tissue disorders	0/14	1/14
Lumbar stenosisMusculoskeletal and connective tissue disorders	0/14	1/14
PresyncopeNervous system disorders	1/14	0/14
Ileocecectomy and resectionSurgical and medical procedures	0/14	1/14
LaminectomySurgical and medical procedures	0/14	1/14
HypotensionVascular disorders	1/14	0/14

Most frequent other events

Showing 10 of 98

Most frequent other events
Event	Standard Therapy	Standard Therapy Plus Tecemotide (L-BLP25)
Lymphocyte count decreasedInvestigations	12/14	14/14
CD4 lymphocytes decreasedInvestigations	9/14	13/14
Hot flushVascular disorders	13/14	11/14
FatigueGeneral disorders	10/14	11/14
Injection site reactionGeneral disorders	1/14	10/14
HyperglycaemiaMetabolism and nutrition disorders	8/14	10/14
AnaemiaBlood and lymphatic system disorders	7/14	9/14
White blood cell count decreasedInvestigations	9/14	7/14
DiarrhoeaGastrointestinal disorders	4/14	7/14
Alanine aminotransferase increasedInvestigations	0/14	6/14

Baseline characteristics

Baseline population included all randomized subjects.

Age, Continuous
Age, Continuous(years)	Standard Therapy	Standard Therapy Plus Tecemotide (L-BLP25)	Total
Median	69.0 (48 to 75)	64 (54 to 78)	64.5 (48 to 78)

Sex: Female, Male
Sex: Female, Male(Participants)	Standard Therapy	Standard Therapy Plus Tecemotide (L-BLP25)	Total
Female	0	0	0
Male	14	14	28

Study locations

1 site

Please Contact US Medical Information
Rockland, Massachusetts, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01496131
Lead sponsor: EMD Serono
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Dec 21, 2011
Start date: Oct 24, 2011
Primary completion: Nov 25, 2016
Completion: Nov 25, 2016
Results posted: Mar 9, 2018
Last update: Mar 9, 2018

Study contacts

Medical Responsible

study director · EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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