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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 : Active, not recruiting
First Posted : June 5, 2014
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 29, 2014
First Posted Date  ICMJE June 5, 2014
Last Update Posted Date July 13, 2018
Actual Study Start Date  ICMJE October 7, 2014
Estimated Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
  • 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 ]
  • Rate and frequency of AEs regardless of causality [ Time Frame: Safety assessments for approximately 2 years ]
  • Rate and frequency of treatment-related AEs [ Time Frame: Safety assessments for approximately 2 years ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02156804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2018)
  • Incidence of all high-grade (Grade 3 and higher) select adverse events [ Time Frame: approximately 2 years ]
  • Median time to onset (Grades 3-4) of select adverse events [ Time Frame: approximately 2 years ]
  • Median time to resolution (Grades 3-4) of select adverse events [ Time Frame: approximately 2 years ]
  • 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 ]
  • Investigator assessed objective response rate (ORR) [ Time Frame: approximately 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
  • Outcome (grade of resolution; duration of Adverse Event (AE)-specific treatment) of all high-grade (CTCAE v4.0 Grade 3 or higher) treatment-related adverse events [ Time Frame: approximately 3 years ]
  • Time to overall survival (OS) and survival at Years 1 and 2 after treatment and beyond [ Time Frame: Survival status every couple of weeks for approximately 8 years, until death, lost to follow-up, or withdrawal of study consent ]
  • Investigator-assessed best overall response (BOR) [ Time Frame: approximately 3 years ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE Drug: Nivolumab (BMS-936558)
Study Arms Experimental: Nivolumab (BMS-936558)
Nivolumab (BMS-936558) Intravenous solution every 2 weeks
Intervention: Drug: Nivolumab (BMS-936558)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 17, 2018)
1215
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2014)
1800
Estimated Study Completion Date January 30, 2019
Estimated Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Czechia,   Finland,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Luxembourg,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02156804
Other Study ID Numbers  ICMJE CA209-172
2014-001286-28 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP