Pembrolizumab-Epacadostat Combination to Treat Muscle-invasive Bladder UrotheLIAl canceR: PECULIAR Study

NCT03832673 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-02-26

No results posted yet for this study

Summary

An open label, monocenter, single-arm, phase 2 study of neoadjuvant pembrolizumab and epacadostat, preceding radical cystectomy, for patients with muscle-invasive bladder cancer.

Conditions

  • Muscle-invasive Bladder Cancer

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV every 3 weeks (for 3 cycles)

DRUG

Epacadostat

Epacadostat 300 mg (BID) orally continuously every 28 days (for 3 cycles)

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Andrea Necchi, MD · Fondazione IRCCS Istituto Nazionale Tumori-Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2019-05-22
Completion
2019-05-22

Countries

  • Italy

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832673 on ClinicalTrials.gov