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Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma

NCT01721772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2022-07-12

Study results available
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Summary

The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

Conditions

Interventions

BIOLOGICAL

BMS-936558 (Nivolumab)

BIOLOGICAL

Placebo matching BMS-936558 (Nivolumab)

DRUG

Dacarbazine

DRUG

Placebo matching Dacarbazine

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-18
Primary Completion
2014-06-24
Completion
2021-05-14
FDA Drug
Yes

Countries

  • Argentina
  • Australia
  • Canada
  • Chile
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Mexico
  • Norway
  • Poland
  • Spain
  • Sweden

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 NCT01721772 on ClinicalTrials.gov