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Spots Global Cancer Trial Database for Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS)

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Trial Identification

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

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

Study ID: NCT05563558

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Hospital Universitario 12 de Octubre, Madrid, , Spain

Contact Details

Name: Enrique Gonzalez-Billalabeitia, Dr

Affiliation: Hospital Universitario 12 de Octubre, Madrid

Role: PRINCIPAL_INVESTIGATOR

Name: Teresa Alonso Gordoa, Dr

Affiliation: Hospital Universitario Ramón y Cajal

Role: PRINCIPAL_INVESTIGATOR

Name: Álvaro Pinto Marín, Dr

Affiliation: Hospital Universitario La Paz

Role: PRINCIPAL_INVESTIGATOR

Name: Ignacio Durán Martínez, Dr

Affiliation: Hospital Universitario Marqués de Valdecilla

Role: PRINCIPAL_INVESTIGATOR

Name: Begoña Mellado González, Dr

Affiliation: Hospital Clinic of Barcelona

Role: PRINCIPAL_INVESTIGATOR

Name: David Lorente Estellés, Dr

Affiliation: Hospital Provincial De Castellón

Role: PRINCIPAL_INVESTIGATOR

Name: Albert Font Pous, Dr

Affiliation: ICO- Badalona

Role: PRINCIPAL_INVESTIGATOR

Name: Sergio Vazquez Estévez, Dr

Affiliation: Hospital Lucus Augusti

Role: PRINCIPAL_INVESTIGATOR

Name: Javier Puente, Dr

Affiliation: Hospital San Carlos, Madrid

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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