HumRes47366
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SNCTP000003924
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BASEC2019-02223
|
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)
Résumé de l'étude
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 étudiée
Experimental arm: nivolumab; indicated dose
Comparator arm: placebo; indicated dose of the placebo equivalent
(BASEC)
Maladie en cours d'investigation
Melanoma
(BASEC)
Critères de participation
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)
Critères d'exclusion
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)
Critères d'exclusion
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)
Lieu de l’étude
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 pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Olivier Michielin
+41 (0) 79 556 18 20
olivier.michielin@clutterchuv.chDepartment of Oncology, Rue de Bugnon 46, 1011, Lausanne
(BASEC)
Informations générales
Bristol-Myers Squibb
(ICTRP)
Informations scientifiques
Bristol-Myers Squibb
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
09.06.2020
(BASEC)
Identifiant de l'essai ICTRP
NCT04099251 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma. (BASEC)
Titre académique
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma (ICTRP)
Titre public
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (ICTRP)
Maladie en cours d'investigation
Melanoma (ICTRP)
Intervention étudiée
Biological: NivolumabOther: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Bristol-Myers Squibb, Bristol-Myers Squibb (ICTRP)
ID secondaires
2019-001230-34, U1111-1229-8927, CA209-76K (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT04099251 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible