To investigate the frequency of V*9Vδ2-T cells in patients with metastatic castration-resistant prostate cancer
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the frequency of Vγ9Vδ2-T cells in patients with metastatic
castration-resistant
prostate cancer.
Secondary outcome
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.
Background summary
LAVA Therapeutics is developing a platform of bispecific antibodies that target
and employ V*9Vδ2-T cells as effector cells. V*9Vδ2-T cells make up
approximately 1-5% of all CD3+ T cells in the peripheral circulation of healthy
individuals and have a critical role in immune surveillance with an ability to
detect and target tumor cells (Lo Presti et al. 2017; de Weerdt et al. 2018;
Kunzmann et al.1999; Gertner-Dardenne et al. 2012). The presence of V*9Vδ2-T
cells in blood and solid tumors correlates with favorable outcomes highlighting
their importance (Gentles et al., 2015, Tosolini et al., 2017). However, levels
of V*9Vδ2-T cells may vary between cancer patients. This study aims to
understand the distribution of V*9Vδ2-T cells and any
factors that influence V*9Vδ2-T frequency.
Study objective
To investigate the frequency of V*9Vδ2-T cells in patients with metastatic
castration-resistant prostate cancer
Study design
A single blood collection during a single visit will be obtained from eligible
patients to assess Vγ9Vδ2-T cell frequency. Demographics, treatment history,
disease history and clinical characteristics will be collected to examine any
correlations with Vγ9Vδ2-T cell frequency. No investigational medicinal product
(IMP) will be administered in this study. The study is for research purposes
only, and data is not intended to be used for
facilitating or informing any clinical or treatment decisions.
Study burden and risks
Patient demographics, clinical characteristics, treatment history, and disease
history will be collected.
A single blood sample will be collected during a single visit.
Patients will not be followed up.
Yalelaan 62
Utrecht 3584 CM
NL
Yalelaan 62
Utrecht 3584 CM
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86570.056.24 |