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Evaluation of V*9Vδ2-T cells in the peripheral blood of patients with metastatic castrationresistant prostate cancer

Evaluation of V*9Vδ2-T cells in the peripheral blood of patients with metastatic castrationresistant prostate cancer - LAVA_GD-01_metastatic castrationresistant prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56769
Enrollment
50
Registered
2024-05-15
Start date
2024-08-13
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mCRPC Prostate Cancer

Interventions

None listed

Sponsors

LAVA Therapeutics NV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients are eligible to be included in the study only if all of the following criteria apply: 1. Patient must be 18 years of age or above at the time of signing the informed consent. 2. Male patient with mCRPC (histologically confirmed adenocarcinoma of the prostate) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria. 3. Patient should have received at least 2 lines of prior therapy in the mCRPC setting, including at least one androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide). Patients may or may not have received a taxane-based chemotherapy. Taxane-naïve patients will not exceed 20% of all patients enrolled. Patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutations should have received a Poly-ADP ribose polymerase (PARP) inhibitor.

Exclusion criteria

Exclusion criteria: Patients are excluded from the study if any of the following criteria apply: 1. Uncontrolled or severe intercurrent medical condition. 2. Adenocarcinoma with small cell or neuroendocrine features.

Design outcomes

Primary

MeasureTime frame
To investigate the frequency of Vγ9Vδ2-T cells in patients with metastatic castration-resistant prostate cancer.

Secondary

MeasureTime frame
To investigate any correlations between the frequency of Vγ9Vδ2-T cells and clinical characteristics. To investigate any correlations between the frequency of Vγ9Vδ2-T cells and treatment history.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)