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Pesquisa Study Connect

Not Yet Recruiting

Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants - CA209-7UA

Atualizado: 30 julho, 2020   |   ClinicalTrials.gov

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Detalhes do estudo

  • Fase 2

    Fase

  • Gênero(s)

  • 12+

    Faixa etária

  • 20

    Localização(ões)

  • Not Yet Recruiting

Opções de tratamento

Braços de tratamento do Estudo
INTERVENÇÃO ATRIBUÍDA
Experimental: Adjuvant treatment
Biological: Nivolumab
Experimental: Neo treat with patho response-driven Adju treat or observation
Biological: Nivolumab Biological: Ipilimumab
Experimental: Neoadjuvant treatment + Adjuvant treatment
Biological: Nivolumab Biological: Ipilimumab

Principais critérios de elegibilidade

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Males and females, ≥ 12 years of age [Except: where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is 18 years of age or local age of majority, inclusive] - Diagnosed with cytologically or histologically confirmed Stage IIIB, IIIC, or IIID cutaneous melanoma as per American Joint Committee on Cancer (AJCC) staging system, with ≥ 1 clinically detectable lymph node metastases (N1b, N2b, N3b), which are measurable according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) - Adult participants and adolescents 16 to 18 years old must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1. Adolescents < 16 years old must have Lanksky Play-Performance Status scale performance of ≥ 60 - Must be treatment-naïve (ie, no prior systemic anticancer therapy as adjuvant therapy for melanoma or unresectable/metastatic melanoma) - Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial Exclusion Criteria: - Women who are breastfeeding - Patients with serious or uncontrolled medical disorders - Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply

É altamente recomendável que você entre em contato com a BMS para relatar efeitos colaterais (eventos adversos).
Efeitos colaterais (eventos adversos) e outros eventos relatáveis estão definidos aqui.
Relate efeitos colaterais (eventos adversos) ou reclamações sobre a qualidade do produto: Informações médicas

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