It is a Phase 2 clinical trial of Pembrolizumab in combination with Carboplatin and Cabazitaxel in Aggressive Variant Metastatic Castration Resistant Prostate Cancer.
It is divided into two parts: an induction period of 6 cycles of 3 weeks each cycle of Pembrolizumab+Cabazitaxel+Carboplatino and a maintenance phase of 15 cycles of 6 weeks each cycle of Pembrolizumab.
Male participants who are at least 18 years of age on the day of signing informed consent
Histologically confirmed diagnosis of adenocarcinoma and/or neuroendocrine carcinoma of the prostate will be enrolled in this study
Presence of metastatic disease documented on imaging studies (bone scan, computed tomography (CT) and/or magnetic resonance imaging (MRI) scans
At least one of the following Aggressive Variant Prostate Cancer (AVPC) Criteria
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), OX-40, CD137).
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to informed consent signature.
Has received previous treatment with cabazitaxel or carboplatin.
Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (non-CNS) disease.
Single group
Pembrolizumab
DrugIncluded in arm/group description
Carboplatin
DrugIncluded in arm/group description
Cabazitaxel
DrugIncluded in arm/group description
Safety - Adverse Events
Incidence of adverse events (AEs) graded according to NCI-CTCAE v 5.0 criteria
Efficacy - Radiographic Progression-Free Survival rate
To assess the safety of pembrolizumab in combination with carboplatin and cabazitaxel according to 6 months Radiographic Progression-Free Survival rate (rPFS) according to the Prostate Cancer Working Group 3 (PCWG3 ).
Efficacy - Progression Free-Survival
To determine radiographic Progression Free-Survival at 12 months
Efficacy - Response rate
To evaluate response rate by Prostate Cancer Working Group (PCWG) modified RECIST 1.1
Efficacy - PSA response
To evaluate PSA response (when PSA is evaluable)
Efficacy - PSA progression-free survival
To determine PSA progression-free survival (PSA-PFS)
Exploratory objective - Correlation of efficacy endpoints with AVPC- Molecular-Classification (MC)
Correlation of efficacy endpoints with AVPC- Molecular-Classification (MC) defined as the presence of tumour mutations in two of the following genes: P53, phosphatase and tensin homolog (PTEN) or Retinoblastoma (RB).
Exploratory objective - Correlation of efficacy endpoints with neuroendocrine signature
Correlation of efficacy endpoints with neuroendocrine signature in the Circulating tumor DNA (ctDNA) methylation pattern.
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