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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04099251
Other study ID # CA209-76K
Secondary ID 2019-001230-34U1
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 28, 2019
Est. completion date June 29, 2027

Study information

Verified date November 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 790
Est. completion date June 29, 2027
Est. primary completion date June 28, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Had a negative sentinel lymph node biopsy - Participant has not been previously treated for melanoma - ECOG 0 or 1 - Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma Exclusion Criteria: - History of ocular or mucosal melanoma. - Pregnant or nursing women - Participants with active known or suspected autoimmune disease - Known history of allergy or hypersensitivity to study drug components - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways Other protocol defined inclusion/exclusion criteria apply.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Nivolumab
Specified dose on specified days
Other:
Placebo
Specified dose on specified days

Locations

Country Name City State
Australia Local Institution - 0019 Box Hill Victoria
Australia Local Institution - 0105 Cairns Queensland
Australia Local Institution - 0125 Geelong Victoria
Australia Local Institution - 0017 Greenslopes Queensland
Australia Local Institution - 0024 Herston Queensland
Australia Local Institution - 0128 Malvern Victoria
Australia Local Institution - 0106 Melbourne Victoria
Australia Local Institution - 0104 Nedlands Western Australia
Australia Local Institution - 0138 Southport Queensland
Australia Local Institution - 0018 Waratah New South Wales
Australia Local Institution - 0025 Westmead New South Wales
Australia Local Institution - 0016 Wollstonecraft New South Wales
Austria Local Institution - 0049 Graz
Austria Local Institution - 0051 Innsbruck
Austria Local Institution - 0050 Salzburg
Austria Local Institution - 0048 Wien
Belgium Local Institution - 0028 Charleroi
Belgium Local Institution - 0011 Gent
Belgium Local Institution - 0008 Kortrijk
Belgium Local Institution - 0010 Liège
Canada Local Institution - 0134 Calgary Alberta
Canada Local Institution - 0131 Halifax Nova Scotia
Canada Local Institution - 0142 Hamilton Ontario
Canada Local Institution - 0124 Kingston Ontario
Canada Local Institution - 0116 Montreal Quebec
Canada Local Institution - 0123 Sherbrooke Quebec
Canada Local Institution - 0140 Toronto Ontario
Canada Local Institution - 0133 Vancouver British Columbia
Czechia Local Institution - 0075 Ostrava-Poruba
Czechia Local Institution - 0074 Prague Praha 2
Czechia Local Institution - 0073 Praha 10
Denmark Local Institution - 0007 Aarhus N
Denmark Local Institution - 0012 Herlev
Denmark Local Institution - 0013 Odense
Finland Local Institution - 0014 Helsinki Etelä-Suomen Lääni
Finland Local Institution - 0015 Tampere Pirkanmaa
Finland Local Institution - 0110 Turku
France Local Institution - 0129 Besancon Cedex
France Local Institution - 0112 Bordeaux
France Local Institution - 0113 Brest Finistère
France Local Institution - 0111 Lille
France Local Institution - 0033 Marseille
France Local Institution - 0035 Nantes
France Local Institution - 0130 Nice
France Local Institution - 0036 Paris
France Local Institution - 0032 Pierre Benite Cedex
France Local Institution - 0034 Villejuif
Germany Local Institution - 0072 Bonn
Germany Local Institution - 0061 Buxtehude
Germany Local Institution - 0098 Dresden
Germany Local Institution - 0054 Essen
Germany Local Institution - 0062 Gera
Germany Local Institution - 0114 Goettingen
Germany Local Institution - 0060 Hannover
Germany Local Institution - 0055 Heidelberg
Germany Local Institution - 0057 Lubeck
Germany Local Institution - 0100 Mainz
Germany Local Institution - 0056 München Bayern
Germany Local Institution - 0102 Regensburg
Germany Local Institution - 0058 Tuebingen
Greece Local Institution - 0082 Athina
Greece Local Institution - 0084 Piraeus
Greece Local Institution - 0083 Thessaloniki
Italy ASST Papa Giovanni XXIII Bergamo
Italy IRCCS Istituto Nazionale Tumori Milano Milano
Italy Istituto Europeo di Oncologia IRCCS Milano
Italy Istituto Nazionale Tumori Fondazione Pascale Napoli
Italy Istituto Oncologico Veneto IOV Padova
Italy A.O.U. Policlinico Paolo Giaccone Palermo Sicilia
Italy Azienda Ospedaliera Di Perugia Perugia
Italy Azienda Ospedaliera Universitaria Senese Siena
Netherlands Local Institution - 0107 Breda
Netherlands Local Institution - 0001 Groningen
Netherlands Local Institution - 0030 Rotterdam
Netherlands Local Institution - 0002 Utrecht
Norway Local Institution - 0063 Bergen
Norway Local Institution - 0027 Gralum
Norway Local Institution - 0005 Oslo
Poland Local Institution - 0023 Gdansk
Poland Local Institution - 0103 Poznan Wielkopolskie
Poland Local Institution - 0022 Warszawa
Romania Local Institution - 0047 Cluj-Napoca
Romania Local Institution - 0020 Craiova
Romania Local Institution - 0021 Sector 2
Spain Local Institution - 0067 A Coruña
Spain Local Institution - 0065 Badalona
Spain Local Institution - 0071 Barcelona
Spain Local Institution - 0066 Madrid
Spain Local Institution - 0070 Madrid
Spain Local Institution - 0068 Malaga
Spain Local Institution - 0064 Santander
Spain Local Institution - 0069 Valencia
Sweden Local Institution - 0003 Linköping Östergötlands Län [se-05]
Sweden Local Institution - 0026 Orebro
Switzerland Local Institution - 0053 Lausanne
Switzerland Local Institution - 0052 Zuerich
United Kingdom Local Institution - 0044 Cardiff
United Kingdom Local Institution - 0095 Southampton
United States Local Institution - 0092 Allentown Pennsylvania
United States Local Institution - 0141 Atlanta Georgia
United States Local Institution - 0091 Aurora Colorado
United States Local Institution - 0144 Austin Texas
United States Local Institution - 0135 Baltimore Maryland
United States Local Institution - 0088 Birmingham Alabama
United States Local Institution - 0078 Boston Massachusetts
United States Local Institution - 0127 Boston Massachusetts
United States Local Institution - 0143 Boston Massachusetts
United States Local Institution - 0086 Charlotte North Carolina
United States Local Institution - 0132 Chicago Illinois
United States Local Institution - 0099 Cleveland Ohio
United States Local Institution - 0085 Dallas Texas
United States Local Institution - 0090 Fairfax Virginia
United States Local Institution - 0148 Germantown Tennessee
United States Local Institution - 0093 Hackensack New Jersey
United States Local Institution - 0080 Los Angeles California
United States Local Institution - 0094 New York New York
United States Local Institution - 0079 Omaha Nebraska
United States Local Institution - 0031 Pittsburgh Pennsylvania
United States Local Institution - 0076 Portland Oregon
United States Local Institution - 0081 Robbinsdale Minnesota
United States Local Institution - 0077 San Francisco California
United States Local Institution - 0119 San Francisco California
United States Local Institution - 0122 San Jose California
United States Local Institution - 0087 Springdale Arkansas
United States Local Institution - 0126 Tucson Arizona
United States Local Institution - 0109 Vallejo California
United States Local Institution - 0120 Vallejo California
United States Local Institution - 0121 Vallejo California
United States Local Institution - 0089 Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Italy,  Netherlands,  Norway,  Poland,  Romania,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence Free Survival (RFS) Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization. From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)
Secondary Distant Metastasis-Free Survival (DMFS) Investigator-assessed distant metastasis-free survival (DMFS) is defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. Participants with no baseline disease assessment, no on-study disease assessments and no death, and no distant metastasis and no death will be censored. Participants with no baseline disease assessment and no on-study disease assessments and death are censored on the date of randomization. Participants with no recurrence and no death will be censored on the date of their last evaluable disease assessment. From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months)
Secondary Duration of Treatment on Next Line Therapy Per Investigator Assessment Duration of treatment is an investigator-assessed outcome of next-line therapy (NLT) defined as the time from first dose date of NLT to last dose date of NLT. Participants who did not stop the NLT were censored. From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)
Secondary Progression-Free Survival Through Next-Line Therapy Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first. Participants who did not receive subsequent systemic anti-cancer therapy who died will be considered as having the event on the date of death. Participants who received subsequent systemic anti-cancer therapy who had a disease progression after the start of therapy will be considered as having the event on the date of disease progression. Participants who died or started second next-line therapy, the date of death or start date of second next-line therapy will be the event date, whichever is earlier. Participants who did not experience disease progression, death, or second next-line therapy will be censored on the last known alive date. From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months)
Secondary Number of Participants Experiencing Adverse Events (AEs) An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary Number of Participants Experiencing Adverse Events Leading to Discontinuation An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary Number of Participants Experiencing Select Adverse Events The number of participants experiencing all-cause select adverse events (AEs). An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary Number of Participants Experiencing Serious Adverse Events (SAEs) A Serious Adverse Events (SAE) is defined as any untoward or unfavorable medical occurrence in a participants that results in death, is life threatening, or places the participant at immediate risk of death from the event as it occurred, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or birth defects, and is another condition which investigators judge to represent significant hazards. From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary Number of Participants Experiencing Death All study participants who died during the blinded phase of the study following treatment. From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters The number of participants experiencing Grade 3 or 4 laboratory abnormalities in the specific pre-determined hematology tests. From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters The number of participants experiencing laboratory abnormalities in the specific pre-determined liver tests. From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary Overall Survival (OS) OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. From randomization up to the date of death or the last date the participant was known to be alive
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