Prostate cancer, biochemical failure after all potentially curative standard local therapies (radiotherapy, brachytherapy and surgery) or biochemical progression while patients have castrated levels of testosterone or after first-line anti hormonal therapy MedDRA version: 12.1 Level: LLT Classification code 10001200 Term: Adenocarcinoma of the prostate stage I
Conditions
Interventions
Product Name: SURVIVAC
Product Code: EMD 640744
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: EMD 640744
Concentration unit: µg microgram(s)
Concentration type: equal
Co
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Histological or cytological confirmation of prostate adenocarcinoma 3. Biochemical recurrence after potentially curative standard therapies for localized disease or Biochemical progression while the patient has castrate levels of testosterone (Castration resistant prostate cancer) or patients with progression after first-line anti hormonal treatment 4. Negative bone scan (performed no more than 90 days prior enrollment) 5. HLA A1, A2, A3, A24 or B7 as assessed by HLA Genotyping 6. ECOG Performance status 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Active malignancy other than prostate cancer 2. Clinical evidence of metastatic disease, local recurrence of pelvic lymph node disease 3. PSA > 10 ng/ml 4. History of past or current autoimmune disease or primary or secondary immunodeficiencies 5. Known hypersensitivity to any component of trial treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the safety and efficacy of Survivac (EMD 640744) emulsified in Montanide ISA 51VG and IMP 321;Secondary Objective: - Evaluation of the ability of the vaccine to induce peptide-specific T cell responses in patients with prostate cancer - Evaluation of the ability of the vaccine to induce T cells capable of recognizing survivin-expressing HLA-class I-matched tumor cells in patients with prostate cancer - Evaluation of the ability of the modified peptides within the vaccine (the A1, A2 and A3 specific peptides) to induce T cells that cross –recognize the native peptide and evaluate the affinity of the cross recognition and implication on recognition of tumor cells - Evaluate changes in PSA serum levels after vaccination compared to baseline - Evaluate the correlation between immunological and clinical responses evaluated as in terms of change in PSA serum levels;Primary end point(s): Incidence of all AEs = grade 2 related to study treatment (including changes in vital signs, laboratory parameters, ECG) and injection site reactions (ISR) | — |
Countries
Italy
Outcome results
None listed