Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT05563558
Brief Summary:
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.
Detailed Description:
Aggressive variant prostate cancer is a clinically defined subset of metastatic castration resistant prostate cancers characterized by the absence of response to AR targeted agents and neuroendocrine features. The treatments that are currently available are not effective and represent an unmet clinical need. This subgroup has been molecularly characterized and associate loss of key tumor suppressors, including TP53, PTEN and RB, and neuroendocrine features. Carboplatin and cabazitaxel have demonstrated promising activity in this scenario although virtually all patients succumb to the disease. Pembrolizumab has demonstrated activity in neuroendocrine tumors. In this trial will be evaluated the activity and safety of pembrolizumab in combination with the most active chemotherapy regiment available to date in aggressive variant prostate cancer, carboplatin plus cabazitaxel
Study:
NCT05563558
Study Brief:
Protocol Section:
NCT05563558