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)

• 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: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: May 29, 2014
• First Posted Date: June 5, 2014
• Results First Submitted Date: January 10, 2020
• Results First Posted Date: February 20, 2020
• Last Update Posted Date: September 11, 2020
• Actual Study Start Date: October 7, 2014
• Actual Primary Completion Date: January 18, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2020)

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.

Original Primary Outcome Measures (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 ]

Current Secondary Outcome Measures (submitted: February 10, 2020)

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

Original Secondary Outcome Measures (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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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 (CheckMate 172)
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Melanoma
• Intervention: Drug: Nivolumab (BMS-936558)

Study Arms

Experimental: Nivolumab (BMS-936558)

Nivolumab (BMS-936558) Intravenous solution every 2 weeks

Intervention: Drug: Nivolumab (BMS-936558)

Publications *

• Schadendorf D, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Nathan P. Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Nov;121:144-153. doi: 10.1016/j.ejca.2019.08.014. Epub 2019 Sep 30.
• Nathan P, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Schadendorf D. Safety and efficacy of nivolumab in patients with rare melanoma subtypes who progressed on or after ipilimumab treatment: a single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Sep;119:168-178. doi: 10.1016/j.ejca.2019.07.010. Epub 2019 Aug 21.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 10, 2020): 1009
• Original Estimated Enrollment (submitted: June 2, 2014): 1800
• Actual Study Completion Date: January 18, 2019
• Actual Primary Completion Date: January 18, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT02156804
• Other Study ID Numbers: CA209-172; 2014-001286-28 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: September 2020