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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)

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ClinicalTrials.gov Identifier: NCT02156804
Recruitment Status : Completed
First Posted : June 5, 2014
Results First Posted : February 20, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1009 participants
Allocation: N/A
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
Actual Primary Completion Date : January 18, 2019
Actual Study Completion Date : January 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

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


Outcome Measures
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Primary Outcome Measures :
  1. the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events. [ Time Frame: Up to 2 years ]
    The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.


Secondary Outcome Measures :
  1. The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events [ Time Frame: Up to 2 years ]
    The number of Participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), select AEs were summarized using the all treated analysis set by system organ class and MedDRA preferred term.

  2. Median Time to Onset (Grades 3-4) of Select Adverse Events [ Time Frame: Up to 2 years. ]
    Select AEs were summarized according to their incidence as well as their time to onset.

  3. Median Time to Resolution (Grades 3-4) of Select Adverse Events [ Time Frame: Up to 2 years ]
    Select AEs were summarized according to their incidence as well as their time to resolution

  4. Overall Survival [ Time Frame: Up to 4 years ]
    The time from first dosing date to the date of death.


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] June 13, 2019
Study Protocol  [PDF] November 17, 2017

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02156804    
Other Study ID Numbers: CA209-172
2014-001286-28 ( EudraCT Number )
First Posted: June 5, 2014    Key Record Dates
Results First Posted: February 20, 2020
Last Update Posted: September 11, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Skin Neoplasms
Neoplasms by Site
Skin Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action