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A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

NCT02714218•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
•Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma \[per American Joint Committee on Cancer (AJCC) staging system\] that is unresectable or metastatic
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
•Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma

Exclusion Criteria

•Subjects with active brain metastases or leptomeningeal metastases
•Subjects with ocular melanoma
•Subjects with active, known or suspected autoimmune disease

Locations (57)

University Of Colorado Cancer Center

Aurora, Colorado, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Allina Health

Fridley, Minnesota, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

University Of Virginia Health System

Charlottesville, Virginia, United States

Key Dates

Start Date

April 4, 2016

Primary Completion Date

April 20, 2017

Completion Date

May 28, 2021

Last Updated

June 24, 2022

Enrollment

387

ACTUAL participants

Conditions

Melanoma

Interventions

Nivolumab 3 mg/kg IV

BIOLOGICAL

Ipilimumab 1 mg/kg IV

BIOLOGICAL

Nivolumab 1 mg/kg IV

BIOLOGICAL

Ipilimumab 3 mg/kg IV

BIOLOGICAL

Nivolumab 6 mg/kg IV

BIOLOGICAL

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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: June 24, 2022Data 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

A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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