Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Prostate Cancer

Korábbi kezelés

• • PSA >5 ng/mL (at screening)
  • Patients who are receiving or have previously received androgen deprivation treatment.
  • Except testosterone has recovered to normal levels: patients who have previously received anti-hormonal treatment testosterone must be >12 nmol/l.
• Patients who are planned to or are undergoing salvage therapy (e.g. radiation)
• Untreated current or prior distant metastasis of PC
• Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anti-cancer therapy
• Autoimmune disease that requires or has required treatment with systemic immunosuppressive treatments, except low dose corticosteroids (< 10 mg/ day), in the past 1 year
• Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery.

Más betegség

• Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and non-muscle invasive bladder cancer.
• Clinical signs of active infection (> grade 2 according to CTCAE v6.0)
• History of HIV infection
• Viral active or chronic hepatitis (HBV or HCV)
• Ongoing relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
• Epilepsy requiring pharmacologic treatment
• Heart failure NYHA III/IV
• Severe obstructive or restrictive ventilation disorder
• Known intolerance to CC-1, or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in the respective drug products (CC-1, VAC-XS15-PC01)

Egyéb

• Clinically significant xerostomia (dry mouth >1grade according to CTCAE v6.0)
• Refrain from blood donation during the course of the study
• Male patients have to refrain from sperm donations for 6 months after last IMP

• Understand and voluntarily sign an IC document prior to any study related assessments/procedures
  • Understand and voluntarily sign an IC document prior to any study related assessments/procedures
  • Patient is able to understand and comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
  • Men aged ≥ 18 and ≤80 years
  • Histologic diagnosis of prostatic adenocarcinoma
  • Biochemical recurrence (BCR): PSA recurrence after treatment with curative intent; PSA ≥0.2 ng/mL or PSA > nadir + 2 ng/mL (after definitive RT), with two increasing PSA values prior to study treatment; AND no distant metastasis upon PSMA-PET imaging
  • Patients are ineligible to receive available treatment alternatives
  • Low risk of rapid disease progression, defined as:
  • o PSA-DT > 1 year AND pathological ISUP grade < 4 for men with prior RP OR Interval to BCR > 18 months AND biopsy ISUP grade < 4 for men with prior radiation therapy
  • In case of second relapse PSA-DT > 9 months
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1