Brief description of trial (Data source: BASEC)
Ziel dieser Studie ist es, die Fixdosiskombination (FDK) aus Nivolumab plus Relatlimab im Vergleich zu Nivolumab allein bei Teilnehmern mit vollständig reseziertem Melanom des Stadiums III-IV zu untersuchen.
Health conditions investigated(Data source: BASEC)
Melanome des Stadiums III-IV
Health conditions
(Data source: WHO)
Melanoma
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Versuchsarm: Arm A: Nivolumab plus Relatlimab
Kombination
Biologikum/Impfstoff: Nivolumab + Relatlimab Fixdosiskombination
Festgelegte Dosis an festgelegten Tagen
Sonstige Bezeichnungen:
BMS-986213
Opdualag
Versuchsarm: Arm B: Nivolumab-Monotherapie
Biologikum/Impfstoff: Nivolumab
Festgelegte Dosis an festgelegten Tagen
Sonstige Bezeichnungen:
Opdivo
BMS-936558
Interventions
(Data source: WHO)
Biological: Nivolumab;Biological: Nivolumab + Relatlimab Fixed Dose Combination
Criteria for participation in trial
(Data source: BASEC)
Eligibility
Für die Studie in Frage kommende Altersgruppen: ab 18 Jahre
Für die Studie in Frage kommende Geschlechter: Basierend auf allen Geschlechtern
Auswahlkriterien in Bezug auf das Geschlecht:
Gesunde Freiwillige zugelassen: Nein
Kriterien
Weitere Informationen über die Teilnahme an klinischen Studien von Bristol-Myers Squibb finden Sie unter: www.BMSStudyConnect.com
Einschlusskriterien:
• Um für die Teilnahme geeignet zu sein, müssen die Diagnose eines Melanoms des Stadiums IIIA (> 1 mm Tumor im Lymphknoten)/B/C/D oder des Stadiums IV laut American Joint Committee on Cancer (AJCC) V8 und ein histologisch bestätigtes Melanom, das vollständig chirurgisch reseziert wurde (krankheitsfrei) und negative Ränder aufweist, vorliegen.
• Teilnehmer müssen einen Leistungsstatus nach Eastern Cooperative Oncology Group (ECOG) von ≤ 1 haben.
• Die Komplettresektion muss innerhalb von 90 Tagen vor der Randomisierung erfolgt sein.
• Alle Teilnehmer müssen gemäß vollständiger körperlicher Untersuchung innerhalb von 14 Tagen vor der Randomisierung und Bildgebung innerhalb von 35 Tagen vor der Randomisierung krankheitsfrei sein.
Es muss Tumorgewebe für Biomarker-Analysen bereitgestellt werden.
Exclusion criteria
(Data source: BASEC)
Ausschlusskriterien:
• Vorgeschichte von Augenmelanom
• Unbehandelte/nicht resezierte ZNS-Metastasen oder leptomeningeale Metastasen
• Aktive, bekannte oder vermutete Autoimmunerkrankung
• Patienten mit schwerer oder nicht kontrollierter Erkrankung
• Vorangegangene Immuntherapie-Behandlung wegen einer früheren malignen Erkrankung: Es sind keine vorangegangenen Immuntherapien zulässig
• Infektion mit dem Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) innerhalb von 4 Wochen vor dem Screening
• Vorgeschichte von Myokarditis, unabhängig von der Ätiologie
Weitere im Prüfplan definierte Einschluss-/Ausschlusskriterien können angewendet werden.
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 12 Years
Inclusion Criteria:
- Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or
Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have
histologically confirmed melanoma that is completely surgically resected (free of
disease) with negative margins in order to be eligible
- Participants = 18 years of age must have an Eastern Cooperative Oncology Group (ECOG)
performance status of = 1. Adolescent participants between 12 and < 18 years of age
must have a Lansky/Karnofsky performance score = 80%
- Complete resection must be performed within 90 days prior to randomization
- All participants must have disease-free status documented by a complete physical
examination within 14 days prior to randomization and imaging studies within 35 days
prior to randomization
- Tumor tissue must be provided for biomarker analyses
Exclusion Criteria:
- History of ocular melanoma
- Untreated/unresected CNS metastases or leptomeningeal metastases
- Active, known, or suspected autoimmune disease
- Participants with serious or uncontrolled medical disorder
- Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are
permitted
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks
prior to screening
- History of myocarditis, regardless of etiology.
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 + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Recurrence-Free Survival (RFS) time per Investigator assessment
Secundary end point
(Data source: WHO)
Overall Survival (OS);Distant Metastasis-Free Survival (DMFS) time per Investigator assessment;Incidence of Adverse Events (AEs);Severity of AEs;Incidence of Serious Adverse Events (SAEs);Severity of SAEs;Incidence of AEs leading to discontinuation (DC);Severity of AEs leading to DC;Incidence of immune-mediated AEs (IMAEs);Severity of IMAEs;Incidence of drug related AEs;Severity of drug related AEs;Incidence of deaths;Incidence of clinically significant changes in clinical laboratory values: Hematology tests;Incidence of clinically significant changes in clinical laboratory values: Chemistry tests;Progression-Free Survival 2 (PFS2)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
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)
Basel, Chur, Zurich
Countries
(Data source: WHO)
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, Norway, Portugal, Romania, Spain, Sweden, Switzerland, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Dr. Reinhard Dummer
+41 442558988
reinhard.dummer@usz.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)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
26.10.2021
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2021-01727
Secondary ID (Data source: WHO)
2021-001641-13
CA224-098
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