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)

September 9, 2020 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1009

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Local Institution
      • Innsbruck, Austria, 6020
        • Local Institution
      • Salzburg, Austria, 5020
        • Local Institution
      • St. Polten, Austria, 3100
        • Local Institution
      • Wein, Austria, 1090
        • Local Institution
      • Wien, Austria, 1030
        • Local Institution
  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Bruxelles, Belgium, 1000
        • Institut Jules Bordet
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Edegem, Belgium, 2650
        • Local Institution
      • Gent, Belgium, 9000
        • Local Institution
      • Hasselt, Belgium, 3500
        • Local Institution
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • Local Institution
      • Liege, Belgium, 4000
        • CHU de Liège
  • Czechia
      • Brno, Czechia, 656 53
        • Local Institution
      • Hradec Kralove, Czechia, 500 05
        • Local Institution
      • Praha 10, Czechia, 100 34
        • Local Institution
      • Praha 2, Czechia, 120 28
        • Local Institution
  • Finland
      • Helsinki, Finland, 00290
        • Local Institution
      • Jyvaskyla, Finland, 40620
        • Local Institution
      • Oulu, Finland, 90220
        • Local Institution
      • Tampere, Finland, 33520
        • Local Institution
  • Germany
      • Augsburg, Germany, 86156
        • Local Institution
      • Bochum, Germany, 44791
        • Local Institution
      • Buxtehude, Germany, 21614
        • Local Institution
      • Chemnitz, Germany, 09117
        • Local Institution
      • Dessau, Germany, 06847
        • Local Institution
      • Dresden, Germany, 01307
        • Local Institution
      • Erfurt, Germany, 99089
        • Local Institution
      • Erlangen, Germany, 91054
        • Local Institution
      • Essen, Germany, 45 122
        • Local Institution
      • Frankfurt Am Main, Germany, 60590
        • Local Institution
      • Freiburg, Germany, 79104
        • Local Institution
      • Gera, Germany, 07548
        • Local Institution
      • Giessen, Germany, 35385
        • Local Institution
      • Goettingen, Germany, 37075
        • Local Institution
      • Hamburg, Germany, 20253
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • Heilbronn, Germany, 74078
        • Local Institution
      • Jena, Germany, 07740
        • Local Institution
      • Kassel, Germany, 34125
        • Local Institution
      • Kiel, Germany, 24105
        • Local Institution
      • Koln, Germany, 50937
        • Local Institution
      • Leipzig, Germany, 04103
        • Local Institution
      • Ludwigshafen, Germany, 67063
        • Local Institution
      • Magdeburg, Germany, 39120
        • Local Institution
      • Mainz, Germany, 55131
        • Local Institution
      • Marburg, Germany, 35043
        • Local Institution
      • Minden, Germany, 32429
        • Local Institution
      • Muenster, Germany, 48149
        • Local Institution
      • Munchen, Germany, 80337
        • Local Institution
      • Munchen, Germany, 81675
        • Local Institution
      • Munster, Germany, 48157
        • Local Institution
      • Nuernberg, Germany, 90419
        • Local Institution
      • Quedlinburg, Germany, 06484
        • Local Institution
      • Recklinghausen, Germany, 45657
        • Local Institution
      • Regensburg, Germany, 93053
        • Local Institution
      • Schwerin, Germany, 19049
        • Local Institution
      • Traunstein, Germany, 83278
        • Local Institution
      • Tubingen, Germany, 72076
        • Local Institution
      • Wurzbug, Germany, 97080
        • Local Institution
    • Schleswig-holstein
      • Luebeck, Schleswig-holstein, Germany, 23538
        • Local Institution
  • Greece
      • Athens, Greece, 11527
        • Local Institution
      • Athens, Greece, 18547
        • Local Institution
      • Thessaloniki, Greece, 54007
        • Local Institution
      • Thessaloniki, Greece, 57010
        • Local Institution
    • Creta
      • Heraklion, Creta, Greece, 71201
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1122
        • Local Institution
      • Budapest, Hungary, H-7085
        • Local Institution
      • Debrecen, Hungary, 4032
        • Local Institution
      • Pecs, Hungary, H-7632
        • Local Institution
      • Szeged, Hungary, H-6720
        • Local Institution
      • Szombathely, Hungary, 9700
        • Local Institution
  • Ireland
      • Dublin, Ireland, 4
        • Local Institution
      • Dublin, Ireland, 8
        • Local Institution
      • Dublin, Ireland, 7
        • Local Institution
      • Dublin, Ireland, 9
        • Local Institution
      • Galway, Ireland
        • Local Institution
      • Waterford, Ireland, 9026
        • Local Institution
    • Cork
      • Wilton, Cork, Ireland
        • Local Institution
  • Italy
      • Bari, Italy, 70124
        • Local Institution
      • Bergamo, Italy, 24127
        • Local Institution
      • Genova, Italy, 16132
        • Local Institution
      • Meldola (FC), Italy, 47014
        • Local Institution
      • Milano, Italy, 20141
        • Local Institution
      • Milano, Italy, 20132
        • Local Institution
      • Milano, Italy, 20133
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Palermo, Italy, 90127
        • Local Institution
      • Roma, Italy, 00144
        • Local Institution
      • Roma, Italy, 00167
        • Local Institution
      • Siena, Italy, 53100
        • Local Institution
      • Terni, Italy, 05100
        • Local Institution
      • Torino, Italy, 10137
        • Local Institution
  • Luxembourg
      • Luxembourg, Luxembourg, 1210
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution
      • Breda, Netherlands, 4918 EV
        • Local Institution
      • Enschede, Netherlands, 7513 ER
        • Local Institution
      • Groningen, Netherlands, 9713 GZ
        • Local Institution
      • Leeuwarden, Netherlands, 8934 AD
        • Local Institution
      • Leiden, Netherlands, 2300 RC
        • Local Institution
      • Maastrict, Netherlands, 6229 HX
        • Local Institution
      • Nijmegen, Netherlands, 6525 GA
        • Local Institution
      • Rotterdam, Netherlands, 3075 EA
        • Local Institution
      • Sittard-Geleen, Netherlands, 6162 BG
        • Local Institution
      • Utrecht, Netherlands, 3584 CX
        • Local Institution
      • Veldhoven, Netherlands, 5504 DB
        • Local Institution
      • Zwolle, Netherlands, 8025-AB
        • Local Institution
    • Noord-holland
      • Amsterdam, Noord-holland, Netherlands, 1081 HZ
        • Local Institution
  • Norway
      • Alesund, Norway, 6017
        • Local Institution
      • Bergen, Norway, 5021
        • Local Institution
      • Oslo, Norway, 0310
        • Local Institution
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Local Institution
      • Gdansk, Poland, 80-952
        • Local Institution
      • Lodz, Poland, 93-513
        • Local Institution
      • Warszawa, Poland, 02781
        • Local Institution
  • Portugal
      • Lisboa, Portugal, 1099-023
        • Local Institution
      • Porto, Portugal, 4200-072
        • Local Institution
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution
      • Romania, Romania, 400015
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Local Institution
      • St. Petersburg, Russian Federation, 197022
        • Local Institution
      • St. Petersburg, Russian Federation, 197758
        • Local Institution
  • Spain
      • Albacete, Spain, 02006
        • Local Institution
      • Barcelona, Spain, 08035
        • Local Institution
      • Barcelona, Spain, 08036
        • Local Institution
      • Barcelona, Spain, 08908
        • Local Institution
      • Bilbao, Spain, 48013
        • Local Institution
      • Granada, Spain, 18014
        • Local Institution
      • Las Palmas de Gran Canaria, Spain, 35016
        • Local Institution
      • Madrid, Spain, 28041
        • Local Institution
      • Madrid, Spain, 28007
        • Local Institution
      • Madrid, Spain, 28046
        • Local Institution
      • Madrid, Spain, 28050
        • Hospital De Madrid, Norte Sanchinarro
      • Malaga, Spain, 29010
        • Local Institution
      • Oviedo, Spain, 33011
        • Local Institution
      • Palma de Mallorca, Spain, 07010
        • Local Institution
      • Salamanca, Spain, 37007
        • Local Institution
      • San Sebastian, Spain, 20014
        • Local Institution
      • Santiago de Compostela, Spain, 15706
        • Hospital Clinico Univ. de Santiago-CHUS
      • Sevilla, Spain, 41071
        • Local Institution
      • Toledo, Spain, 45071
        • Local Institution
      • Valencia, Spain, 46009
        • Local Institution
      • Valencia, Spain, 46026
        • Local Institution
  • Sweden
      • Lund, Sweden, 221 85
        • Local Institution
      • Uppsala, Sweden, 751 85
        • Local Institution
  • Switzerland
      • Aarau, Switzerland, 5001
        • Local Institution
      • Basel, Switzerland, 4031
        • Local Institution
      • Bellinzona, Switzerland, 6501
        • Local Institution
      • Chur, Switzerland, 7000
        • Local Institution
      • Zurich, Switzerland, 8091
        • Local Institution
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Local Institution
      • Cambridge, United Kingdom, CB2 0QQ
        • Local Institution
      • Cottingham, United Kingdom, HU16 5JQ
        • Local Institution
      • Essex, United Kingdom
        • Local Institution
      • Glasgow, United Kingdom, G12 0YN
        • Local Institution
      • London, United Kingdom, SE1 9RT
        • Local Institution
      • Manchester, United Kingdom, M20 4BX
        • Local Institution
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Local Institution
      • Oxford, United Kingdom, OX3 7LE
        • Local Institution
      • Southampton, United Kingdom, SO16 6YD
        • Local Institution
      • Surrey, United Kingdom, SM2 5PT
        • Local Institution
      • Swansea, United Kingdom, SA2 8QA
        • Local Institution
      • Truro, United Kingdom, TR1 3LJ
        • Local Institution
      • Wirral, United Kingdom, CH63 4JY
        • Local Institution
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8ED
        • Local Institution
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nivolumab (BMS-936558)
Nivolumab (BMS-936558) Intravenous solution every 2 weeks
Drug: Nivolumab (BMS-936558)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years
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.
Up to 2 years.
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
Up to 2 years
Overall Survival
Time Frame: Up to 4 years
The time from first dosing date to the date of death.
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-172
  • 2014-001286-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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