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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)
研究概览
简要总结
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard therapy
Radiation therapy in combination with androgen deprivation therapy (ADT).
干预措施: Radiation therapy (Radiation)
Standard therapy
Radiation therapy in combination with androgen deprivation therapy (ADT).
干预措施: Goserelin (Drug)
Standard therapy plus tecemotide (L-BLP25)
Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
干预措施: Radiation therapy (Radiation)
Standard therapy plus tecemotide (L-BLP25)
Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
干预措施: Goserelin (Drug)
Standard therapy plus tecemotide (L-BLP25)
Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
干预措施: Cyclophosphamide (Drug)
Standard therapy plus tecemotide (L-BLP25)
Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
干预措施: Tecemotide (L-BLP25) (Drug)
结局指标
主要结局
Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)
时间窗: 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)
时间窗: 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).
次要结局
- Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels(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)(Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT))