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
Oppdatert:
30 Juli, 2020
|
ClinicalTrials.gov
Fase
Kjønn
Aldersgruppe
Sted(er)
Not Yet Recruiting
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
Vi anbefaler at du kontakter BMS for å rapportere bivirkninger.
Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon
MLTNO2000046