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)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Melanoma

Treatments: Drug: Nivolumab (BMS-936558)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02156804

2014-001286-28 (EudraCT Number)

CA209-172

Details and patient eligibility

About

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.

Enrollment: 1,009 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,009 participants in 1 patient group

Nivolumab (BMS-936558)

Experimental group

Description:

Nivolumab (BMS-936558) Intravenous solution every 2 weeks

Treatment:

Drug: Nivolumab (BMS-936558)