Study evaluating the efficacy of nivolumab compared to a placebo in preventing recurrent melanoma after complete resection of a stage IIB/C melanoma (CheckMate76K)

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

ID di studio ICTRP
NCT04099251 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma. (BASEC)

Titolo accademico
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma (ICTRP)

Titolo pubblico
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (ICTRP)

Malattie studiate
Melanoma (ICTRP)

Intervento studiato
Biological: NivolumabOther: Placebo (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)

Criteri di inclusione/esclusione
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 disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Bristol-Myers Squibb, Bristol-Myers Squibb (ICTRP)

ID secondari
2019-001230-34, U1111-1229-8927, CA209-76K (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT04099251 (ICTRP)