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)
Zusammenfassung der Studie
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)
Untersuchte Intervention
Experimental arm: nivolumab; indicated dose
Comparator arm: placebo; indicated dose of the placebo equivalent
(BASEC)
Untersuchte Krankheit(en)
Melanoma
(BASEC)
Kriterien zur Teilnahme
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)
Ausschlusskriterien
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)
Ausschlusskriterien
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)
Studienstandort
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)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Olivier Michielin
+41 (0) 79 556 18 20
olivier.michielin@clutterchuv.chDepartment of Oncology, Rue de Bugnon 46, 1011, Lausanne
(BASEC)
Allgemeine Auskünfte
Bristol-Myers Squibb
(ICTRP)
Wissenschaftliche Auskünfte
Bristol-Myers Squibb
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.06.2020
(BASEC)
ICTRP Studien-ID
NCT04099251 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma. (BASEC)
Wissenschaftlicher Titel
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma (ICTRP)
Öffentlicher Titel
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (ICTRP)
Untersuchte Krankheit(en)
Melanoma (ICTRP)
Untersuchte Intervention
Biological: NivolumabOther: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Bristol-Myers Squibb, Bristol-Myers Squibb (ICTRP)
Sekundäre IDs
2019-001230-34, U1111-1229-8927, CA209-76K (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT04099251 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar