ClinicalTrials.gov
ClinicalTrials.gov Menu

A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)

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: NCT02156804
Recruitment Status : Active, not recruiting
First Posted : June 5, 2014
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Nivolumab (BMS-936558) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1215 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody
Actual Study Start Date : October 7, 2014
Estimated Primary Completion Date : June 10, 2018
Estimated Study Completion Date : June 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab (BMS-936558)
Nivolumab (BMS-936558) Intravenous solution every 2 weeks
Drug: Nivolumab (BMS-936558)



Primary Outcome Measures :
  1. Rate and frequency for high-grade (CTCAE v4.0 Grade 3 or higher) treatment-related, select adverse events in subjects with melanoma [ Time Frame: Safety assessments for approximately 2 years ]
  2. Rate and frequency of AEs regardless of causality [ Time Frame: Safety assessments for approximately 2 years ]
  3. Rate and frequency of treatment-related AEs [ Time Frame: Safety assessments for approximately 2 years ]
  4. Rate and frequency of any AEs of special interest (AEOSI), such as pulmonary, gastrointestinal, cuteaneous, renal, hepatic, pancreatic, endocrine, infusion-related, or hypersensitivity [ Time Frame: Safety assessments for approximately 2 years ]

Secondary Outcome Measures :
  1. Incidence of all high-grade (Grade 3 and higher) select adverse events [ Time Frame: approximately 2 years ]
  2. Median time to onset (Grades 3-4) of select adverse events [ Time Frame: approximately 2 years ]
  3. Median time to resolution (Grades 3-4) of select adverse events [ Time Frame: approximately 2 years ]
  4. Time to overall survival (OS) [ Time Frame: Survival status every couple of weeks for up to approximately 2 years, until death, lost to follow-up, or withdrawal of study consent ]
  5. Investigator assessed objective response rate (ORR) [ Time Frame: approximately 2 years ]


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 BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects with histologically confirmed malignant melanoma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):

    • PS 0 to 1
    • PS 2
  • Previously treated unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status
  • Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors (RECIST 1.1)-defined disease progression
  • Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2), BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with known cKIT mutations are allowed
  • Patients with CNS metastases are eligible:

    • if CNS metastases are treated, patients are asymptomatic or neurologically returned to baseline
    • if they have previously untreated CNS metastases and are asymptomatic
    • if they have leptomeningeal metastases, are treated and asymptomatic or neurologically returned to baseline with life expectancy > 3 months
  • Patients with a known history of Grades 3-4 immune-related adverse reactions during/after anti-CTLA-4 therapy if all toxicities have resolved at least to Grade 1

Exclusion Criteria:

  • Subjects with untreated, active Central Nervous System (CNS) metastases are excluded

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): NCT02156804


  Show 172 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: NCT02156804     History of Changes
Other Study ID Numbers: CA209-172
2014-001286-28 ( EudraCT Number )
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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
Antibodies
Antibodies, Monoclonal
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents