RecruitingPhase 2NCT05563558

Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS)

A Phase 2 Clinical Trial of Pembrolizumab in Combination With Carboplatin and Cabazitaxel in Aggressive Variant Metastatic Castration Resistant Prostate Cancer


Sponsor

Fundacion Oncosur

Enrollment

42 participants

Start Date

May 5, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a three-drug combination — pembrolizumab (immunotherapy), carboplatin (chemotherapy), and cabazitaxel (chemotherapy) — for men with an aggressive form of castration-resistant prostate cancer that has spread to other parts of the body. This is a particularly hard-to-treat subtype that often doesn't respond well to standard hormone therapies. **You may be eligible if...** - You are a male aged 18 or older - You have metastatic prostate cancer confirmed by biopsy - Your cancer meets at least one criterion for aggressive variant prostate cancer (e.g., neuroendocrine features, organ metastases, high LDH, fast progression to castration-resistance) - You are in good functional health (ECOG 0 or 1) - You have measurable disease on imaging - You have prior tumor tissue available for testing **You may NOT be eligible if...** - You do not meet the aggressive variant criteria - Your overall health status doesn't allow participation - You have significant organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Included in arm/group description

DRUGCarboplatin

Included in arm/group description

DRUGCabazitaxel

Included in arm/group description


Locations(1)

Hospital Universitario 12 de Octubre

Madrid, Spain

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NCT05563558


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