HumRes47366
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SNCTP000003924
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BASEC2019-02223
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NCT04099251
Study evaluating the efficacy of nivolumab compared to a placebo in preventing recurrent melanoma after complete resection of a stage IIB/C melanoma (CheckMate76K)
Summary description of the study
The objective of this study is to determine the efficacy of adjuvant immunotherapy with nivolumab compared to a placebo in adult participants who have undergone complete resection of a stage IIB/C melanoma with no evidence of disease (NED) and who are at high risk of recurrence.
(BASEC)
Intervention under investigation
Experimental arm: nivolumab; indicated dose
Comparator arm: placebo; indicated dose of the placebo equivalent
(BASEC)
Disease under investigation
Melanoma
(BASEC)
Criteria for participation in trial
Minimum age: 18 years Maximum age: - Criteria: inclusion criteria: • Had a negative sentinel lymph node biopsy • The participant has not been previously treated for melanoma • ECOG 0 or 1 • Participants must have received a diagnosis of histologically confirmed stage IIB/C cutaneous melanoma that has been resected Other inclusion criteria defined in the protocol are applicable. (BASEC)
Exclusion criteria
History of ocular or mucosal melanoma. • Pregnant or breastfeeding women • Participants with proven or suspected autoimmune disease • Known history of allergy or hypersensitivity to components of the study drug. • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or with agents targeting IL-2 pathways, T-cell stimulators, or checkpoint pathways Other exclusion criteria defined in the protocol are applicable. (BASEC)
Minimum age: 18 years Maximum age: - Criteria: inclusion criteria: • Had a negative sentinel lymph node biopsy • The participant has not been previously treated for melanoma • ECOG 0 or 1 • Participants must have received a diagnosis of histologically confirmed stage IIB/C cutaneous melanoma that has been resected Other inclusion criteria defined in the protocol are applicable. (BASEC)
Exclusion criteria
History of ocular or mucosal melanoma. • Pregnant or breastfeeding women • Participants with proven or suspected autoimmune disease • Known history of allergy or hypersensitivity to components of the study drug. • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or with agents targeting IL-2 pathways, T-cell stimulators, or checkpoint pathways Other exclusion criteria defined in the protocol are applicable. (BASEC)
Trial sites
Lausanne
(BASEC)
Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom, United States (ICTRP)
Sponsor
Bristol-Myers Squibb Company Route 206, Province Line Road Princeon NJ, 08543 United Stets of America Sponsor´s representative in Switzeland Carmen Lilla Bristol-Myers Squibb SA Hinterbergstrasse 16 6312 Steinhausen Switzerland
(BASEC)
Contact
Contact Person Switzerland
Prof. Olivier Michielin
+41 (0) 79 556 18 20
olivier.michielin@clutterchuv.chDepartment of Oncology, Rue de Bugnon 46, 1011, Lausanne
(BASEC)
General Information
Bristol-Myers Squibb
(ICTRP)
Scientific Information
Bristol-Myers Squibb
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
09.06.2020
(BASEC)
ICTRP Trial ID
NCT04099251 (ICTRP)
Official title (approved by ethics committee)
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma. (BASEC)
Academic title
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma (ICTRP)
Public title
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (ICTRP)
Disease under investigation
Melanoma (ICTRP)
Intervention under investigation
Biological: NivolumabOther: Placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Inclusion/Exclusion criteria
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. (ICTRP)
not available
Primary and secondary end points
Recurrence Free Survival (RFS) (ICTRP)
Distant Metastasis-Free Survival (DMFS);Duration of Treatment on Next Line Therapy Per Investigator Assessment;Progression-Free Survival Through Next-Line Therapy;Number of Participants Experiencing Adverse Events (AEs);Number of Participants Experiencing Adverse Events Leading to Discontinuation;Number of Participants Experiencing Select Adverse Events;Number of Participants Experiencing Serious Adverse Events (SAEs);Number of Participants Experiencing Death;Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters;Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters;Overall Survival (OS) (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Bristol-Myers Squibb, Bristol-Myers Squibb (ICTRP)
Secondary trial IDs
2019-001230-34, U1111-1229-8927, CA209-76K (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT04099251 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available