Stage III (Unresectable) or Stage IV Advanced MelanomaCheckmate 168NCT02142218
Expanded Access Program With Nivolumab to Treat Melanoma
A study testing Nivolumab in people with Stage III (Unresectable) or Stage IV Advanced Melanoma, run by Bristol-Myers Squibb at 80 sites in 6 countries.
Trial summary
The purpose of this program is to provide treatment with nivolumab to subjects with Stage III or Stage IV advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III (Unresectable) or Stage IV Advanced Melanoma
- What is being tested?
- Nivolumab
- How many people
- Not given
- Where
- 80 sitesin 6 countries
- Study dates
- Jun 2014to May 2018
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- ECOG Performance Status of 0-1
- Histologically confirmed malignant melanoma
- Progressed on or after treatment with an anti-CTLA4
Who cannot join
- 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
Trial locations and contacts
80 sites in 6 countries.
80 sites in 6 countries
United States23 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Winship Cancer Institute
Atlanta, Georgia, 30322
St. Luke'S Hospital
Bethlehem, Pennsylvania, 18015
Lynn Cancer Institute At Boca Raton Regional Hospital
Boca Raton, Florida, 33486
Mid Ohio Oncology/Hematology, Inc,Dba
Columbus, Ohio, 43219
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733
Local Institution
Encinitas, California, 92024
The Jones Clinic, Pc
Germantown, Tennessee, 38138
Cancer Specialists Of North Florida
Jacksonville, Florida, 32256
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, 89148
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Lutherville, Maryland, 21093
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Local Institution
Mobile, Alabama, 36604
Southern Cancer Center Pc
Mobile, Alabama, 36608
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Icahn School Of Medicine At Mount Sinai
New York, New York, 10029
Oncology Hematology Associates Of Sw In
Newburgh, Indiana, 47630
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Florida Hospital
Orlando, Florida, 32803
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068
Summit Cancer Care
Savannah, Georgia, 31404
Local Institution
Washington D.C., District of Columbia, 20057
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Brazil22 sites
Local Institution
Barretos, São Paulo, 14780
Local Institution
Belo Horizonte, Minas Gerais, 30150
Local Institution
Belo Horizonte, Minas Gerais, 30380
Local Institution
Brasília, Federal District, 70200
Local Institution
Florianópolis, Santa Catarina, 88015
Local Institution
Fortaleza, Ceará, 60130
Local Institution
Ijuí, Rio Grande do Sul, 98700
Local Institution
Itajaí, Santa Catarina, 88301
Local Institution
Jaú, São Paulo, 17210
Local Institution
Jd. Petropolis-Londrina, Paraná, 86015
Local Institution
Passo Fundo, Rio Grande do Sul, 99010
Local Institution
Porto Alegre, Rio Grande do Sul, 90840
Local Institution
Ribeirão Preto, São Paulo, 14025
Local Institution
Salvador, Estado de Bahia, 41950
Local Institution
Santo André, São Paulo, 09060
Local Institution
São José do Rio Preto, São Paulo, 15090
Local Institution
São Paulo, São Paulo, 01308
Local Institution
São Paulo, São Paulo, 01323
Local Institution
São Paulo, São Paulo, 01509
Local Institution
São Paulo, São Paulo, 03102
Local Institution
São Paulo, São Paulo, 04538
Local Institution
São Paulo, São Paulo, 05651
Canada17 sites
Local Institution
Calgary, Alberta, T2N 4N2
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Halifax, Nova Scotia, B3H 1V7
Local Institution
Hamilton, Ontario, L8V 5C2
Local Institution
Kelowna, British Columbia, V1Y 5L3
Local Institution
London, Ontario, N6A 4L6
Local Institution
Moncton, New Brunswick, E1C 8X3
Local Institution
Montreal, Quebec, H3T 1E2
Local Institution
North Vancouver, British Columbia, V7L 2L7
Local Institution
Ottawa, Ontario, K1H 8L6
Local Institution
Québec, Quebec, G1R 2J6
Local Institution
Saskatoon, Saskatchewan, S7N 4H4
Local Institution
St. John's, Newfoundland and Labrador, A1B 3V6
Local Institution
Toronto, Ontario, M4N 3M5
Local Institution
Toronto, Ontario, M5G 2M9
Local Institution
Vancouver, British Columbia, V5Z 4E6
Local Institution
Winnipeg, Manitoba, R3E 0V9
Argentina9 sites
Local Institution
Buenos Aires, Buenos Aires, 1019
Local Institution
Buenos Aires, Buenos Aires, 1431
Local Institution
Caba, 1426
Local Institution
Capital Federal, Buenos Aires, 1280
Local Institution
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181
Local Institution
Córdoba, Córdoba Province, 5000
Local Institution
Rosario, Santa Fe Province, S2000DSK
Local Institution
San Miguel de Tucumán, Tucumán Province, 4000
Local Institution
San Miguel de Tucumán, Tucumán Province, CPT4000IAK
Colombia5 sites
Local Institution
Bogotá, 110221
Local Institution
Bogotá
Local Institution
Cali
Local Institution
Medellín, MEDELLIN
Local Institution
Medellín
Peru4 sites
Local Institution
Lima, Lima Province, 34
Local Institution
Lima, Lima Province
Local Institution
Lima, 027
Local Institution
Lima
About this study
Official title: 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.
- Being tested
- Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III (Unresectable) or Stage IV Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142218
- Sponsor's protocol ID
- CA209-168
- Acronym
- Checkmate 168
- Status last verified
- Sep 2016
- First submitted
- 16 May 2014
- Last updated
- 29 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02142218
- Acronym / sponsor ID
- Checkmate 168 / CA209-168
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this program is to provide treatment with nivolumab to subjects with Stage III or Stage IV advanced melanoma.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ECOG Performance Status of 0-1
- Histologically confirmed malignant melanoma
- Progressed on or after treatment with an anti-CTLA4
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
Related trials for Stage III (Unresectable) or Stage IV Advanced Melanoma
RecruitingPhase 2
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Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
Active, not recruitingPhase 2/3
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
Stage III Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7
Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
RecruitingPhase 1/2
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
Recurrent Melanoma (Skin), Metastatic Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
80 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nivolumab in people with Stage III (Unresectable) or Stage IV Advanced Melanoma, run by Bristol-Myers Squibb at 80 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Brazil, Canada, Argentina, Colombia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.