Trial Outcomes & Findings for Tecemotide (L-BLP25) in Prostate Cancer (NCT NCT01496131)
NCT ID: NCT01496131
Last Updated: 2018-03-09
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline and Day 60 (Pre-Radiation)
Results posted on
2018-03-09
Participant Flow
First subject First Visit/Last Subject Last Visit: 24 October 2011/25 November 2016.
Participant milestones
| Measure |
Standard Therapy
Subjects 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 Androgen Deprivation Therapy (ADT).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tecemotide (L-BLP25) in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Standard Therapy
n=14 Subjects
Subjects 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.
|
Standard Therapy Plus Tecemotide (L-BLP25)
n=14 Subjects
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.
|
Total
n=28 Subjects
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 years
n=93 Participants
|
64 years
n=4 Participants
|
64.5 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 60 (Pre-Radiation)Population: Analysis population included only subjects who had scored positive to viral pool in peripheral blood mononuclear cells and were considered as evaluable. Here, "Number of Participants Analyzed" signifies subjects evaluable for this outcome measure.
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).
Outcome measures
| Measure |
Standard Therapy
n=9 Participants
Subjects 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.
|
Standard Therapy Plus Tecemotide (L-BLP25)
n=8 Participants
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.
|
|---|---|---|
|
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 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 190 (Post-radiation)Population: Analysis population included only subjects who had scored positive to viral pool in peripheral blood mononuclear cells and were considered as evaluable. Here, "Number of Participants Analyzed" signifies subjects evaluable for this outcome measure.
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).
Outcome measures
| Measure |
Standard Therapy
n=8 Participants
Subjects 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.
|
Standard Therapy Plus Tecemotide (L-BLP25)
n=6 Participants
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.
|
|---|---|---|
|
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 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From randomization up to 24 monthsPopulation: Analysis population included all subjects randomized in the study.
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.
Outcome measures
| Measure |
Standard Therapy
n=14 Participants
Subjects 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.
|
Standard Therapy Plus Tecemotide (L-BLP25)
n=14 Participants
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.
|
|---|---|---|
|
Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)Population: Analysis population included only the subjects who were randomized and provided consent for biopsy and whose baseline measurement was considered as evaluable. Here, "number analyzed" signifies subjects evaluable at specified time point and "number analyzed"=0 signifies that no subjects were evaluable at the specified time point.
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).
Outcome measures
| Measure |
Standard Therapy
n=1 Participants
Subjects 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.
|
Standard Therapy Plus Tecemotide (L-BLP25)
n=7 Participants
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.
|
|---|---|---|
|
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)
Pre-RT
|
1 Participants
|
1 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)
Post-RT
|
—
|
1 Participants
|
Adverse Events
Standard Therapy
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Standard Therapy Plus Tecemotide (L-BLP25)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Therapy
n=14 participants at risk
Subjects 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.
|
Standard Therapy Plus Tecemotide (L-BLP25)
n=14 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis;hip replacement surgery
|
0.00%
0/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Lumbar stenosis
|
0.00%
0/14
|
7.1%
1/14
|
|
Nervous system disorders
Presyncope
|
7.1%
1/14
|
0.00%
0/14
|
|
Surgical and medical procedures
Ileocecectomy and resection
|
0.00%
0/14
|
7.1%
1/14
|
|
Surgical and medical procedures
Laminectomy
|
0.00%
0/14
|
7.1%
1/14
|
|
Vascular disorders
Hypotension
|
7.1%
1/14
|
0.00%
0/14
|
Other adverse events
| Measure |
Standard Therapy
n=14 participants at risk
Subjects 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.
|
Standard Therapy Plus Tecemotide (L-BLP25)
n=14 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
7/14
|
64.3%
9/14
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/14
|
7.1%
1/14
|
|
Cardiac disorders
Palpitations
|
7.1%
1/14
|
0.00%
0/14
|
|
Eye disorders
Vertigo
|
7.1%
1/14
|
0.00%
0/14
|
|
Eye disorders
Eye Redness and discomfort in left Eye
|
0.00%
0/14
|
7.1%
1/14
|
|
Eye disorders
Vision blurred
|
7.1%
1/14
|
0.00%
0/14
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
1/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14
|
14.3%
2/14
|
|
Gastrointestinal disorders
Anal incontinence
|
7.1%
1/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14
|
21.4%
3/14
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
4/14
|
50.0%
7/14
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14
|
14.3%
2/14
|
|
Gastrointestinal disorders
GI bleed - GI Virus
|
7.1%
1/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Haemorrhoids
|
14.3%
2/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14
|
21.4%
3/14
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/14
|
7.1%
1/14
|
|
Gastrointestinal disorders
Proctitis
|
21.4%
3/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
7.1%
1/14
|
0.00%
0/14
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14
|
7.1%
1/14
|
|
General disorders
Chills
|
7.1%
1/14
|
0.00%
0/14
|
|
General disorders
Fatigue
|
71.4%
10/14
|
78.6%
11/14
|
|
General disorders
Influenza like illness
|
0.00%
0/14
|
7.1%
1/14
|
|
General disorders
Injection site reaction
|
7.1%
1/14
|
71.4%
10/14
|
|
General disorders
Non-cardiac chest pain
|
7.1%
1/14
|
0.00%
0/14
|
|
General disorders
Oedema peripheral
|
14.3%
2/14
|
21.4%
3/14
|
|
General disorders
Pain
|
7.1%
1/14
|
21.4%
3/14
|
|
General disorders
Pyrexia
|
7.1%
1/14
|
0.00%
0/14
|
|
Infections and infestations
Scabies
|
0.00%
0/14
|
7.1%
1/14
|
|
Infections and infestations
Skin infection
|
7.1%
1/14
|
0.00%
0/14
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/14
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
7.1%
1/14
|
0.00%
0/14
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14
|
42.9%
6/14
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14
|
21.4%
3/14
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
1/14
|
7.1%
1/14
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/14
|
14.3%
2/14
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14
|
21.4%
3/14
|
|
Investigations
CD4 lymphocytes decreased
|
64.3%
9/14
|
92.9%
13/14
|
|
Investigations
Lymphocyte count decreased
|
85.7%
12/14
|
100.0%
14/14
|
|
Investigations
Neutrophil count decreased
|
21.4%
3/14
|
21.4%
3/14
|
|
Investigations
Platelet count decreased
|
0.00%
0/14
|
35.7%
5/14
|
|
Investigations
Weight increased
|
0.00%
0/14
|
7.1%
1/14
|
|
Investigations
White blood cell count decreased
|
64.3%
9/14
|
50.0%
7/14
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/14
|
21.4%
3/14
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
57.1%
8/14
|
71.4%
10/14
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14
|
21.4%
3/14
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/14
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
28.6%
4/14
|
28.6%
4/14
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
1/14
|
21.4%
3/14
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
14.3%
2/14
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.1%
1/14
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/14
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
1/14
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Polydipsia
|
7.1%
1/14
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.1%
1/14
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14
|
21.4%
3/14
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.6%
4/14
|
7.1%
1/14
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14
|
0.00%
0/14
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14
|
0.00%
0/14
|
|
Nervous system disorders
Headache
|
7.1%
1/14
|
7.1%
1/14
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14
|
14.3%
2/14
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14
|
0.00%
0/14
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14
|
0.00%
0/14
|
|
Psychiatric disorders
Hesitancy
|
7.1%
1/14
|
0.00%
0/14
|
|
Renal and urinary disorders
Cystitis noninfective
|
14.3%
2/14
|
28.6%
4/14
|
|
Renal and urinary disorders
Haematuria
|
14.3%
2/14
|
14.3%
2/14
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/14
|
7.1%
1/14
|
|
Renal and urinary disorders
Micturition urgency
|
7.1%
1/14
|
7.1%
1/14
|
|
Renal and urinary disorders
Pollakiuria
|
21.4%
3/14
|
0.00%
0/14
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/14
|
7.1%
1/14
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
1/14
|
7.1%
1/14
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/14
|
7.1%
1/14
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
21.4%
3/14
|
7.1%
1/14
|
|
Reproductive system and breast disorders
Gynaecomastia
|
7.1%
1/14
|
7.1%
1/14
|
|
Reproductive system and breast disorders
Scrotal pain
|
7.1%
1/14
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.1%
1/14
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Tick bite
|
0.00%
0/14
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/14
|
7.1%
1/14
|
|
Vascular disorders
Hot flush
|
92.9%
13/14
|
78.6%
11/14
|
|
Vascular disorders
Hypertension
|
0.00%
0/14
|
14.3%
2/14
|
|
Vascular disorders
Hypotension
|
7.1%
1/14
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Early satiety
|
0.00%
0/14
|
7.1%
1/14
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Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place