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)

Phase 2

Completed

• Conditions: Melanoma
• Interventions: Drug: Nivolumab (BMS-936558)

• Registration Number: NCT02156804
• Lead Sponsor: Bristol-Myers Squibb

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 available

Study Timeline

• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-05
• Study Start: 2014-10-07
• Primary Completion: 2019-01-18
• Study Completion: 2019-01-18
• Results First Submitted: 2020-01-10
• Results First Submitted QC: 2020-02-10
• Results First Posted: 2020-02-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1009

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

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Exclusion Criteria

• Subjects with untreated, active Central Nervous System (CNS) metastases are excluded

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab (BMS-936558)	Nivolumab (BMS-936558)	Nivolumab (BMS-936558) Intravenous solution every 2 weeks

Primary Outcome Measures

Name	Time	Method
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 4 years	The time from first dosing date to the date of death.
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events	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	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	Up to 2 years	Select AEs were summarized according to their incidence as well as their time to resolution

Trial Locations

Locations (8)

Local Institution; 🇬🇧 Wirral, United Kingdom

Hospital De Madrid, Norte Sanchinarro; 🇪🇸 Madrid, Spain

Hospital Clinico Univ. de Santiago-CHUS; 🇪🇸 Santiago de Compostela, Spain

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium

Institut Jules Bordet; 🇧🇪 Bruxelles, Belgium

Chu De Liege; 🇧🇪 Liege, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium

Az Groeninge; 🇧🇪 Kortrijk, Belgium