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A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Unresectable or Metastatic Melanoma

Thank you

Trial Information

A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma


CheckMate 067: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 067


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:



- Histologically confirmed stage III (unresectable) or stage IV melanoma

- Treatment naïve patients

- Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI)
per RECIST 1.1 criteria

- Tumor tissue from an unresectable or metastatic site of disease for biomarker
analyses

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases

- Ocular melanoma

- Subjects with active, known or suspected autoimmune disease

- Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within
14 days of treatment

- Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed
Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated
antigen-4 (anti-CTLA-4) antibody

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Endpoint of Overall Survival (OS) in all randomized subjects

Outcome Description:

OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. OS data will be collected continuously while subjects are on study medication and every 3 months via in-person or phone contact after discontinuation of study medication

Outcome Time Frame:

Approximately up to 44.1 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Institutional Review Board

Study ID:

CA209-067

NCT ID:

NCT01844505

Start Date:

June 2013

Completion Date:

January 2017

Related Keywords:

  • Unresectable or Metastatic Melanoma
  • Melanoma

Name

Location

Duke Cancer InstituteDurham, North Carolina  27710
Local InstitutionChicago, Illinois  
Local InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionPortland, Oregon  
Local InstitutionVancouver, Washington  
Local InstitutionPhoenix, Arizona  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionHamden, Connecticut  
Local InstitutionWashington, District of Columbia  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionAlbuquerque, New Mexico  
Local InstitutionWilmington, North Carolina  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionAustin, Texas  
Local InstitutionRome, Georgia  
Local InstitutionChattanooga, Tennessee  
Local InstitutionSalt Lake City, Utah  
Local InstitutionJackson, Mississippi  
Local InstitutionColumbia, Missouri  
New York Oncology Hematology, PCAlbany, New York  12208
Maine Center for Cancer MedicineScarborough, Maine  04074
The Angeles Clinic and Research InstituteLos Angeles, California  90025
Sarah Cannon Research InstituteNashville, Tennessee  37203
Local InstitutionDetroit, Michigan  
Local InstitutionLas Vegas, Nevada  
Greenville Health SystemGreenville, South Carolina  29615