Malignant MelanomaCheckMate218NCT02186249
Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma
A study testing Nivolumab and Ipilimumab in people with Malignant Melanoma, run by Bristol-Myers Squibb at 66 sites in 2 countries.
Trial summary
The purpose of this study is to provide treatment with nivolumab in combination with ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have unresectable or metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Nivolumab and Ipilimumab
- How many people
- Not given
- Where
- 66 sitesin 2 countries
- Study dates
- Start not givento not given
- 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
- Men and women 18 years and older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Histologically-confirmed unresectable stage III or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system, Including mucosal and ocular melanoma
- Subjects must be anti-CTLA-4 treatment-naive and anti-PD-1 treatment-naive. Subjects may have had other prior systemic treatment for localized or metastatic disease
- Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in Immunosuppression (>10 mg/day prednisone equivalent) for at least 2 weeks prior to study drug administration
Who cannot join
- Active (symptomatic) and not treated brain metastases or leptomeningeal metastases
- Life expectancy < 6 weeks
- Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in absence of an external trigger are permitted to enroll
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
- Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2, anti-CT137 (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or subject is expected to require any other form of systemic antineoplastic therapy while receiving nivolumab
Trial locations and contacts
66 sites in 2 countries.
66 sites in 2 countries
United States57 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Winship Cancer Institute
Atlanta, Georgia, 30322
University of Colorado Hospital
Aurora, Colorado, 80045
Texas Oncology
Austin, Texas, 78731
6501 Truxtun Avenue
Bakersfield, California, 93309
Medstar Health Research Institute
Baltimore, Maryland, 21204
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Center For Cancer and Blood Disorders
Bethesda, Maryland, 20817
St Luke's Hospital
Bethlehem, Pennsylvania, 18015
Massachusetts General Hospital
Boston, Massachusetts, 02214
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Carolinas Healthcare System
Charlotte, North Carolina, 28204
Karmanos Cancer Institute
Detroit, Michigan, 48201
Greenville Health System
Easley, South Carolina, 29640
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
Memorial Regional Hospital
Hollywood, Florida, 33021
MD Anderson Cancer Center
Houston, Texas, 77030
4500 San Pablo Road South
Jacksonville, Florida, 32224
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120
UF Health Cancer Center at Orlando Health
Longwood, Florida, 32750
100 UCLA Medical Plaza
Los Angeles, California, 90095
Local Institution
Louisville, Kentucky, 40202
University of Wisconsin
Madison, Wisconsin, 53792
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Texas Oncology
Midland, Texas, 79701
Atlantic Health System
Morristown, New Jersey, 07960-1089
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Smilow Cancer Hospital at Yale University Cancer Center
New Haven, Connecticut, 06519
NYU Langone Medical Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10017
600 Celebrate Life Parkway
Newnan, Georgia, 30265
Oncology Specialists, SC
Niles, Illinois, 60714
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Texas Oncology
Paris, Texas, 75460
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Northwest Cancer Specialists PC
Portland, Oregon, 97213
514 North Prospect Ave
Redondo Beach, California, 90277
Virginia Cancer Institute
Richmond, Virginia, 23230
Oncology and Hematology Associates of Southwest Virginia, Inc
Roanoke, Virginia, 24014
Mayo Clinic
Rochester, Minnesota, 55905
California Pacific Medical Center Research Institute
San Francisco, California, 94115
University of California San Francisco
San Francisco, California, 94115
Angeles Clinic and Research Institute
Santa Monica, California, 90404
1325 East Church Street
Santa Monica, California, 93454
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Tulsa Cancer Institute PLLC
Tulsa, Oklahoma, 74146
Georgetown-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Shenandoah Oncology Association
Winchester, Virginia, 22601
Canada9 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Grand River Hospital
Kitchener, Ontario, N2G 1G3
London Health Sciences Centre
London, Ontario, N6A 4L6
McGill University Health Center
Montreal, Quebec, H4A 3J1
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Chuq Centre Hospitalier Universitaire de Quebec
Québec, G1R 2J6
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Subjects With Unresectable or Metastatic Melanoma
The purpose of this study is to provide treatment with nivolumab in combination with ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have unresectable or metastatic melanoma.
- Conditions
- Malignant Melanoma
- Being tested
- Nivolumab, Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
IpilimumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant 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
- NCT02186249
- Sponsor's protocol ID
- CA209-218
- Acronym
- CheckMate218
- Status last verified
- Feb 2017
- First submitted
- 8 Jul 2014
- Last updated
- 8 Feb 2017
- Results posted
- No
Publications
Hodi FS, Chapman PB, Sznol M, Lao CD, Gonzalez R, Smylie M, Daniels GA, Thompson JA, Kudchadkar R, Sharfman W, Atkins M, Spigel DR, Pavlick A, Monzon J, Kim KB, Ernst S, Khushalani NI, van Dijck W, Lobo M, Hogg D. Safety and efficacy of combination nivolumab plus ipilimumab in patients with advanced melanoma: results from a North American expanded access program (CheckMate 218). Melanoma Res. 2021 Feb 1;31(1):67-75. doi: 10.1097/CMR.0000000000000708.
PubMed 33234846
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Subjects With Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT02186249
- Acronym / sponsor ID
- CheckMate218 / CA209-218
- Conditions
- Malignant Melanoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 10 Jul 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 study is to provide treatment with nivolumab in combination with ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have unresectable or metastatic melanoma.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women 18 years and older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Histologically-confirmed unresectable stage III or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system, Including mucosal and ocular melanoma
- Subjects must be anti-CTLA-4 treatment-naive and anti-PD-1 treatment-naive. Subjects may have had other prior systemic treatment for localized or metastatic disease
- Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in Immunosuppression (>10 mg/day prednisone equivalent) for at least 2 weeks prior to study drug administration
Key exclusion criteria (5 listed)
- Active (symptomatic) and not treated brain metastases or leptomeningeal metastases
- Life expectancy < 6 weeks
- Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in absence of an external trigger are permitted to enroll
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
- Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2, anti-CT137 (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or subject is expected to require any other form of systemic antineoplastic therapy while receiving nivolumab
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 | – |
| Ipilimumab | 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 8 Feb 2017.
- Derived from this study: PubMed 33234846Hodi FS, Chapman PB, Sznol M, Lao CD, Gonzalez R, Smylie M, Daniels GA, Thompson JA, Kudchadkar R, Sharfman W, Atkins M, Spigel DR, Pavlick A, Monzon J, Kim KB, Ernst S, Khushalani NI, van Dijck W, Lobo M, Hogg D. Safety and efficacy of combination nivolumab plus ipilimumab in patients with advanced melanoma: results from a North American expanded access program (CheckMate 218). Melanoma Res. 2021 Feb 1;31(1):67-75. doi: 10.1097/CMR.0000000000000708.
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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
66 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nivolumab and Ipilimumab in people with Malignant Melanoma, run by Bristol-Myers Squibb at 66 sites in 2 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 5 inclusion and 5 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Canada. 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?
On the ClinicalTrials.gov record for NCT02186249, which also lists 1 linked publication.
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 8 Feb 2017.