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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

NCT02714218 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2022-06-24

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

Nivolumab 3 mg/kg IV

Followed by Nivolumab monotherapy

BIOLOGICAL

Ipilimumab 1 mg/kg IV

Followed by Nivolumab monotherapy

BIOLOGICAL

Nivolumab 1 mg/kg IV

BIOLOGICAL

Ipilimumab 3 mg/kg IV

BIOLOGICAL

Nivolumab 6 mg/kg IV

A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to \~ 480mg.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-04
Primary Completion
2017-04-20
Completion
2021-05-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02714218 on ClinicalTrials.gov