Prostate CancerPhase 2NCT01496131
Tecemotide (L-BLP25) in Prostate Cancer
A Phase 2 study testing Radiation therapy, Goserelin and Cyclophosphamide in people with Prostate Cancer, run by EMD Serono at 1 site in United States.
Trial summary
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiation therapy, Goserelin and Cyclophosphamide
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2011to 25 Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Please Contact US Medical Information
Rockland, Massachusetts
About this study
Official title: A Randomized Phase II Study of Tecemotide in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Untreated, Intermediate and High Risk Prostate Cancer Patients
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Radiation therapy, Goserelin, Cyclophosphamide, Tecemotide (L-BLP25)
- Keywords
- Tecemotide, Prostate Cancer, Goserelin, Cyclophosphamide, Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.
GoserelinDrug
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.
CyclophosphamideDrug
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).
Tecemotide (L-BLP25)Drug
Also called L-BLP25, BLP25 liposome vaccine, Epipepimut-S
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | Active comparator | Radiation therapy in combination with androgen deprivation therapy (ADT). Receives: Radiation: Radiation therapy; Drug: Goserelin |
| Standard therapy plus tecemotide (L-BLP25) | Experimental | Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25). Receives: Radiation: Radiation therapy; Drug: Goserelin; Drug: Cyclophosphamide; Drug: Tecemotide (L-BLP25) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and Day 190 (Post-radiation)
Secondary outcomes (2)
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.
Measured: 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).
Measured: Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study start24 Oct 2011
- Primary completion25 Nov 2016
- Study completion25 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496131
- Sponsor's protocol ID
- EMR 63325-015
- Other IDs
- BB-IND 7787
- Status last verified
- Feb 2018
- First submitted
- 3 Nov 2011
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Tecemotide in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Untreated, Intermediate and High Risk Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT01496131
- Acronym / sponsor ID
- EMR 63325-015
- Conditions
- Prostate Cancer
- Keywords
- Tecemotide, Prostate Cancer, Goserelin, Cyclophosphamide, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Oct 2011 (actual)
- Primary completion
- 25 Nov 2016 (actual)
- Study completion
- 25 Nov 2016 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Posted 9 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy | Active comparator | Radiation: Radiation therapy, Drug: GoserelinRadiation therapy in combination with androgen deprivation therapy (ADT). |
| Standard therapy plus tecemotide (L-BLP25) | Experimental | Radiation: Radiation therapy, Drug: Goserelin, Drug: Cyclophosphamide, Drug: Tecemotide (L-BLP25)Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyRadiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks. | Radiation | Standard therapy, Standard therapy plus tecemotide (L-BLP25) |
| GoserelinADT (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. | Drug | Standard therapy, Standard therapy plus tecemotide (L-BLP25) |
| CyclophosphamideCyclophosphamide 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). | Drug | Standard therapy plus tecemotide (L-BLP25) |
| Tecemotide (L-BLP25)Also: L-BLP25, BLP25 liposome vaccine, Epipepimut-STecemotide (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. | Drug | Standard therapy plus tecemotide (L-BLP25) |
Primary outcome
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)
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).
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)
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 secondary outcomes
Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels
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)
Time frame: Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation therapy, Goserelin and Cyclophosphamide in people with Prostate Cancer, run by EMD Serono at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.