A Vaccine and an Antibody Drug for Prostate Cancer That Has Come Back
Tests a peptide vaccine and an antibody in men with relapsed prostate cancer.
Plain-language title generated from the registry record
Registry title: Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Prostate Cancer
Key facts
- Where
- Berlin, Essen, Heidelberg, and Tuebingen, GermanySee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07860047, who can take part
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
- Universitaetsklinikum Essen (AoR)Essen, GermanyNot yet recruiting
- National Center for Tumor Diseases (NCT) HeidelbergHeidelberg, GermanyNot yet recruiting
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Tuebingen
- Trial code
- NCT07860047EU 2025-522144-41-00
- Record updated
- 6 October 2026
- Original description
This trial is a phase II, randomized, open label study designed to evaluate safety, tolerability and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity, and of VACXS15-PC01, a prostate cancer (PC)-specific multi-peptide vaccine, both administered as single agent or in combination to patients affected with biochemical recurrence (BCR) of PC after local therapy with curative intent. Patients will not receive other treatments during trial participation.Read full original descriptionShow less
Randomized Phase II Study of Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Biochemical Relapse of Prostate Cancer
This trial is a phase II, randomized, open label study designed to evaluate safety, tolerability and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity, and of VACXS15-PC01, a prostate cancer (PC)-specific multi-peptide vaccine, both administered as single agent or in combination to patients affected with biochemical recurrence (BCR) of PC after local therapy with curative intent. Patients will not receive other treatments during trial participation.
Inclusion: 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.
Exclusion: • 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; 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); 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.