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Rechercher sur 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

Mis à jour: 30 juillet, 2020   |   ClinicalTrials.gov

Impression du resumé

SONGEZ-VOUS À PARTICIPER À CET ESSAI?
Imprimez cette page et le guide pour vous aider dans vos échanges avec votre médecin.
Utilisez le guide en matière d’essai pour connaître le processus de participation à un essai clinique. Soyez au fait des principaux facteurs à considérer avant de prendre une décision et dressez la liste des questions à poser à l’équipe de soins de santé.

Détails de l’essai

  • Phase 2

    Phase

  • Sexe(s)

  • 12+

    Tranche d’âge

  • 20

    Emplacement(s)

  • Not Yet Recruiting

Options de traitement

Groupes de l’étude
INTERVENTION ATTRIBUÉE
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

Principaux critères d’admissibilité

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

Nous vous recommandons fortement de contacter BMS pour signaler les effets secondaires (événements indésirables).
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici.
Signaler des effets secondaires (effets indésirables) ou des plaintes concernant la qualité du produit: Informations médicales

Des questions? Le support en direct est disponible 24/7 - Veuillez composer le 833-673-6134 ou Envoyez-nous un courriel

Des questions? Le support en direct est disponible 24/7 -
Veuillez composer le 833-673-6134 ou Envoyez-nous un courriel