Overview

This trial is active, not recruiting.

Condition melanoma
Treatment nivolumab (bms-936558)
Phase phase 2
Sponsor Bristol-Myers Squibb
Start date October 2014
End date February 2018
Trial size 800 participants
Trial identifier NCT02156804, 2014-001286-28, CA209-172

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Nivolumab (BMS-936558) Intravenous solution every 2 weeks
nivolumab (bms-936558)

Primary Outcomes

Measure
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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.