Registration: ClinicalTrials.gov
Last updated: 25 Ianuarii, 2016
Id pelagus: NCT02659059
Registration Date: January XV, MMXVI
Main sponsor: Bristol-Myers Squibb
Argumentum apertum: Nivolumab plus Ipilimumab ut curatio primi lineae pro scaena IV cancri pulmonis non parvae LAPIS LAPIS 568
Scientific topic: An titulus aperto, unius brachium-II studio tempus Nivolumab combined per Ipilimumab ut prius, linea parva cellula pulmonis cancer curatio est non-scaena III (NSCLC)
Tempore primae cooptatione: Februarii MMXVI
Scopum magnitudine: CLXX
SUPPLEMENTUM status: recruiting
Typus de studio, operam
Studium Design: Endpoint System: Safety / studio Efficens, Allocutio Model: Officium unam classem constituunt, Masking: In Label, utuntur: Treatment
Guide: pars II
Recruiting terris;
United States
Exclusio et ingressum clavem criteria:
Pro magis notitia, de Bristold 'myers (BMS) orci iudicium participes, placet visitare www.BMSSstudyConnect.com
Ingressum criteria:
- Masculus an femina es XVIII annos vel senior
- IV cellula parva scaena pulmonis cancer diagnosis de non-
- The diagnosis of relapsed stage IIIB non-small cell lung cancer and previous combination therapy with radiotherapy and chemotherapy failed treatment without further therapeutic options.
Exclusio criteria:
- Potis est plaga furens ira cum studio metastases de systematis nervosi centralis excluduntur
- Furens ira cum carcinomati similis MENINGITIS
- Activae subiectum habet, sciri vel autoimmune morbo suspected
- Quod cum aegris morbo systemica studium eget curatio opus inter quas corticosteroids (> X mg per die, equivalent de valium) immunosuppressive medicinae vel uti se intra XIV dies primi curatio
- Women qui erant gravida, aut facti gravida ut ante treatment consilium coeperunt, et / vel lactavit in studio.
- Et inclusion / exclusio defined cogitationum ab aliis applicari potest ad vexillum.
Minimum aetatis terminum: XVIII annorum
Aetatis maxime modus, Nullum
Genus: genus
A. MCCCIV,
Biologics: Nivolumab (Opdivo) + Ipilimumab (Yervoy)
Pelagus eventus:
Rate objective Dominum nostrum Response (Orr) [Tempus dolor, post VI menses ad extremum patientes estote primi curatio]
Secundarium results:
Responsum duratione (DOR) [tempus frame, patientes estote ultimum VI mensibus post curatio primum]
Progression-free survival (PFS) [Time frame: last patient 6 months after first treatment]
VI-mensis-liberum progressum salvos (PFS) [tempus frame: VI menses post primum dose]
Nivolumab (Opdivo) nivolumab: The FDA approved nivolumab on March 4, 2015 for the treatment of metastatic squamous non-small cell lung cancer with disease progression during or after platinum-based chemotherapy. Previously (in December 2014), the FDA accelerated approval of nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma who did not respond to other drugs. Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1, PD-L2, thus releasing the PD-1 pathway-mediated suppression of the immune response, including anti- Tumor immune response. Two studies establish FDA approval. The FDA approval is based on the results of an open-label, multi-center, multi-country randomized trial comparing the efficacy of nivolumab and docetaxel. The study targeted patients with metastatic squamous non-small cell lung cancer. These patients experienced disease progression during or after platinum-based chemotherapy. Patients were randomly assigned to receive nivolumab intravenously 3 mg / kg every 2 weeks (n = 135), or docetaxel 75 mg / m2 intravenously every 3 weeks (n = 137). The primary study endpoint was OS.
Inter has formas, de Nivolumab squama NSCLC confirmata est adhuc in uno-brachium non-parva cellula squama negaret CXVII casibus de pulmone cancer. Omni studio participantium in hoc morbo peritus Lorem fundatur-platinum, post progressum et systemica saltem alio victus modo curatio. In cohortibus XV% de aegris cum summa responsionis LIX% de quibus responsum quoque tempore VI menses, aut magis.
The efficacy of Nivolumab in the treatment of squamous NSCLC was confirmed in a randomized clinical study involving 272 patients, of which 135 patients received nivolumab and 137 patients received docetaxel. The primary endpoint of the study was overall survival, and it was found that nivolumab prolonged the overall survival by an average of 3.2 months compared to docetaxel. Another one-arm study involving 117 patients undergoing platinum-based chemotherapy and at least one systemic therapy for patients with advanced lung cancer further confirmed the safety and efficacy of nivolumab. The primary endpoints of the study were the objective response rate (ORR) and the proportion of patients with locally reduced or disappeared tumors. The results showed that 15% of patients produced an objective response, and 59% of patients maintained an objective response for 6 months or longer.
Ipilimumab (Yervoy) Ipilimumab: CTLA IV-T lymphocytes moderator, negans est, quod potest impedire eius activation. Et impedit eum a IV-CTLA Ipilimumab ligat ad mutuo occurrant cum suis ligand (CD4 / CD4). Clausus CTLA IV-activation cellula, et non multiplices T proventus. Quod autem effectus in Ipilimumab melanoma est per accidens, potest per immune responsio ad anti-tumore mediata per T cellulis.
