ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02714218
Recruitment Status : Active, not recruiting
First Posted : March 21, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Melanoma Biological: 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 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 24, 2016
Actual Primary Completion Date : April 20, 2017
Estimated Study Completion Date : April 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
Specified dose on specified days
Biological: Nivolumab 3 mg/kg IV
Followed by Nivolumab monotherapy

Biological: Ipilimumab 1 mg/kg IV
Followed by Nivolumab monotherapy

Experimental: Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
Specified dose on specified days
Biological: Nivolumab 1 mg/kg IV
Biological: Ipilimumab 3 mg/kg IV
Experimental: Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg
Specified dose on specified days
Biological: Ipilimumab 1 mg/kg IV
Followed by Nivolumab monotherapy

Biological: Nivolumab 6 mg/kg IV



Primary Outcome Measures :
  1. Incidence of drug-related Grade 3 - 5 Adverse Events (AEs) [ Time Frame: After 6 months from the first dose of study treatment ]

Secondary Outcome Measures :
  1. Objective I Response Rate (ORR) [ Time Frame: After 6 months from the first dose of study treatment ]
  2. Overall survival (OS) [ Time Frame: After 6 months from the first dose of study treatment ]
  3. Mean changes from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) global health status/quality of life (Qol) composite scale [ Time Frame: After 6 months from the first dose of study treatment ]
  4. Progression Free Survival (PFS) in all treated subjects [ Time Frame: After 6 months from the first dose of study treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714218


  Show 57 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02714218     History of Changes
Other Study ID Numbers: CA209-511
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs