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Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma

A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy

NCT01709162•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
•Histologic diagnosis of unresectable stage III or IV metastatic melanoma
•Prior ipilimumab induction treatment (3 mg/kg)
•Documented disease control \[Stable Disease ≥3 months or Partial Response/Complete Response\] after ipilimumab induction
•Documented progressive disease following disease control

Exclusion Criteria

•Patients with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab
•Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
•Patients who experienced any grade 3 immune-related adverse event (irAE) (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab
•Patients with a prior irAE that has not improved to grade 1 or better at randomization

Locations (17)

Birmingham Hematology & Oncology Associates Llc

Birmingham, Alabama, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Investigative Clinical Research Of Indiana, Llc

Indianapolis, Indiana, United States

Cancer Center Of Kansas

Wichita, Kansas, United States

Comprehensive Cancer Center Of Nevada

Las Vegas, Nevada, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Texas Oncology Sammons Cancer Center

Dallas, Texas, United States

Local Institution

Vienna, Austria

Local Institution

Bordeaux, France

Local Institution

Nantes, France

Key Dates

Start Date

March 1, 2013

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

November 30, 2015

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

Ipilimumab

BIOLOGICAL

Chemotherapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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