Expanded Access Program With Nivolumab to Treat Melanoma (Checkmate 168)

September 28, 2016 updated by: Bristol-Myers Squibb

Expanded Access Program With Nivolumab for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Systemic Treatment Containing an Anti CTLA-4 Monoclonal Antibody (Checkmate 168: CHECKpoint Pathway for nivoluMAb Clinical Trial Evaluation 168)

The purpose of this program is to provide treatment with nivolumab to subjects with Stage III or Stage IV advanced melanoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

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.
Expanded Access

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

  • Argentina
      • Buenos Aires, Argentina, 1431
        • Local Institution
      • Buenos Aires, Argentina, 1019
        • Local Institution
      • Caba, Argentina, 1426
        • Local Institution
      • Cordoba, Argentina, 5000
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1280
        • Local Institution
      • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
        • Local Institution
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSK
        • Local Institution
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, 4000
        • Local Institution
      • San Miguel De Tucuman, Tucuman, Argentina, CPT4000IAK
        • Local Institution
  • Brazil
      • Sao Paulo, Brazil, 01323
        • Local Institution
      • Sao Paulo, Brazil, 01509
        • Local Institution
      • Sao Paulo, Brazil, 01308
        • Local Institution
      • Sao Paulo, Brazil, 03102
        • Local Institution
      • Sao Paulo, Brazil, 04538
        • Local Institution
      • Sao Paulo, Brazil, 05651
        • Local Institution
    • Bahia
      • Salvador, Bahia, Brazil, 41950
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brazil, 60130
        • Local Institution
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70200
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150
        • Local Institution
      • Belo Horizonte, Minas Gerais, Brazil, 30380
        • Local Institution
    • Parana
      • Jd. Petropolis-Londrina, Parana, Brazil, 86015
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90840
        • Local Institution
    • Rio Grande do Sul
      • Ijui, Rio Grande do Sul, Brazil, 98700
        • Local Institution
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010
        • Local Institution
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil, 88015
        • Local Institution
      • Itajai, Santa Catarina, Brazil, 88301
        • Local Institution
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14780
        • Local Institution
      • Jau, Sao Paulo, Brazil, 17210
        • Local Institution
      • Ribeirao Preto, Sao Paulo, Brazil, 14025
        • Local Institution
      • Santo Andre, Sao Paulo, Brazil, 09060
        • Local Institution
      • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090
        • Local Institution
  • Canada
      • Quebec, Canada, G1R 2J6
        • Local Institution
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Local Institution
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Local Institution
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Local Institution
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Local Institution
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Local Institution
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Local Institution
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Local Institution
      • London, Ontario, Canada, N6A 4L6
        • Local Institution
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Local Institution
  • Colombia
      • Bogota, Colombia
        • Local Institution
      • Bogota, Colombia, 110221
        • Local Institution
      • Cali, Colombia
        • Local Institution
      • Medellin, Colombia
        • Local Institution
      • Medellin, Colombia, MEDELLIN
        • Local Institution
  • Peru
      • Lima, Peru
        • Local Institution
      • Lima, Peru, 34
        • Local Institution
      • Lima, Peru, 027
        • Local Institution
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center Pc
      • Mobile, Alabama, United States, 36604
        • Local Institution
    • California
      • Encinitas, California, United States, 92024
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Local Institution
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Cancer Institute At Boca Raton Regional Hospital
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
      • Savannah, Georgia, United States, 31404
        • Summit Cancer Care
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Oncology Hematology Associates of SW IN
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
    • New York
      • East Setauket, New York, United States, 11733
        • North Shore Hematology/Oncology Associates, P.C.
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Mid Ohio Oncology/Hematology, Inc,Dba
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic, PC
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Waukesha Memorial Hospital

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

N/A

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • ECOG Performance Status of 0-1
  • Histologically confirmed malignant melanoma
  • Progressed on or after treatment with an anti-CTLA4

Exclusion Criteria:

  • Active brain metastases
  • Life Expectancy <6 weeks
  • Subjects who received prior therapy targeting T-cell costimulation or checkpoint pathways except for Anti CTLA-4 therapy
  • Subjects with autoimmune disease

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?

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.

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

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.
June 1, 2014

Primary Completion (Anticipated)

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.
May 1, 2018

Study Completion (Anticipated)

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.
May 1, 2018

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 16, 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.
May 16, 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.
May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

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 29, 2016

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 28, 2016

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, 2016

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.
  • CA209-168

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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