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First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma

NCT01524991 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-07-11

Study results available
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Summary

Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab has shown intriguing activity as neoadjuvant therapy in patients with clinically localized bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin, plus ipilimumab may build on the chemosensitivity of urothelial carcinoma to produce more durable responses and improved outcomes.

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)

DRUG

Cisplatin

Cisplatin 70 mg/m2 Day 1 (all cycles)

DRUG

Ipilimumab

Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Sponsors & Collaborators

Principal Investigators

  • Matthew Galsky, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2017-07-15
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01524991 on ClinicalTrials.gov