Clinical trial · Interventional
Tecemotide (L-BLP25) in Prostate Cancer
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
NCT01496131CI-TRIAL-00032007completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Goserelin | Drug | Goserelin | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
| Tecemotide (L-BLP25) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard therapy
- description
- Radiation therapy in combination with androgen deprivation therapy (ADT).
- interventionNames
- Radiation: Radiation therapy
- Drug: Goserelin
- type
- EXPERIMENTAL
- label
- Standard therapy plus tecemotide (L-BLP25)
- description
- Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
- interventionNames
- Radiation: Radiation therapy
- Drug: Goserelin
- Drug: Cyclophosphamide
- Drug: Tecemotide (L-BLP25)
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.