Phase 1b/2 clinical trial of combination therapies with pembrolizumab (MK-3475) in metastatic castration-resistant prostate cancer (MCRPC) (KEYNOTE-365).

Principal Investigator

Dott.ssa Alessandra Mosca

Contact Information for Access

• alessandra.mosca@inoc.it
• ilaria.buondonno@inoc.it
• ufficio.trials@inoc.it

Phase

FASE II

Status

ATTIVO

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Objective of the study

1. To evaluate the safety and tolerability of combination therapy with pembrolizumab.

2. Estimate the PSA response rate to combination therapy with pembrolizumab. A PSA response is defined as a reduction in PSA level of 50% or more from baseline, confirmed twice at intervals of at least 3 weeks.

3. Estimate the objective response rate (ORR) according to RECIST 1.1 criteria, as assessed by the BICR.

Prostate

(Neuroendocrine mCRPC)

Pathologies

Male urologic cancers (urological tumors)

Medication

Pembrolizumab + Carboplatin + Etoposide or Carboplatin + Etoposide

Who is eligible to participate in the study?

Patients who are 18 years of age or older and who meet the study’s eligibility criteria may participate in this study.
Patients will be assigned to one of the following cohorts based on their prior treatment for mCRPC and other eligibility criteria for each cohort. The investigator’s choice of standard of care will also be used to assign subjects due to some overlap in the admission criteria.

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