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

Intervention model single group assignment
Primary purpose treatment
Masking no masking
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

All 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 March 2017.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.