Brief description of trial (Data source: BASEC)
L’objectif de cette étude est de déterminer l’efficacité d’une immunothérapie adjuvante par le nivolumab, comparativement à un placebo, chez des participants adultes, ayant subi la résection complète d’un mélanome de stade IIB/C sans aucune preuve de maladie (NED), et qui présentent un risque élevé de récidive.
Health conditions investigated(Data source: BASEC)
Mélanome
Health conditions
(Data source: WHO)
Melanoma
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Bras expérimental: nivolumab; dose indiquée
Bras comparateur: placebo; dose indiquée de l’équivalent placebo
Interventions
(Data source: WHO)
Biological: Nivolumab;Other: Placebo
Criteria for participation in trial
(Data source: BASEC)
Age minimum: 18 ans
Age maximum: -
Critères: critères d’inclusion:
• Avait une biopsie négative du ganglion lymphatique sentinelle
• Le participant n’a pas été préalablement traité pour le mélanome
• ECOG 0 ou 1
• Les participants doivent avoir reçu le diagnostic de mélanome cutané de stade IIB/C confirmé à l’analyse histologique, réséqué
Les autres critères d’inclusion définis dans le protocole sont applicables.
Exclusion criteria
(Data source: BASEC)
Antécédents de mélanome oculaire ou des muqueuses.
• Femmes enceintes ou allaitantes
• Participants présentant une maladie auto-immune avérée ou suspectée
• Antécédents connus d’allergie ou d’hypersensibilité aux composants du médicament de l’étude.
• Traitement préalable avec un anticorps anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, ou avec des agents qui ciblent les voies IL-2, les stimulateurs des cellules T ou les voies des checkpoints
Les autres critères d’exclusion définis dans le protocole sont applicables.
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 12 Years
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.
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Recurrence Free Survival (RFS)
Secundary end point
(Data source: WHO)
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)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Lausanne
Countries
(Data source: WHO)
Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Olivier Michielin
+41 (0) 79 556 18 20
olivier.michielin@chuv.ch
Contact for general information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Contact for scientific information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Date of authorisation by the ethics committee
09.06.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-02223
Secondary ID (Data source: WHO)
2019-001230-34
U1111-1229-8927
CA209-76K
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