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A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial.
Clarke, Jeffrey M; Gu, Lin; Wang, Xiaofei F; Stinchcombe, Thomas E; Stevenson, Marvaretta M; Ramalingam, Sundhar; Shariff, Afreen; Garst, Jennifer; Nixon, Andrew B; Antonia, Scott J; Crawford, Jeffrey; Ready, Neal E.
Afiliação
  • Clarke JM; Duke Cancer Institute, Durham, North Carolina.
  • Gu L; Department of Medicine, Duke University School of Medicine, Durham, North Carolina.
  • Wang XF; Duke Cancer Institute, Durham, North Carolina.
  • Stinchcombe TE; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.
  • Stevenson MM; Duke Cancer Institute, Durham, North Carolina.
  • Ramalingam S; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.
  • Shariff A; Duke Cancer Institute, Durham, North Carolina.
  • Garst J; Department of Medicine, Duke University School of Medicine, Durham, North Carolina.
  • Nixon AB; Department of Medicine, Duke University School of Medicine, Durham, North Carolina.
  • Antonia SJ; Duke Raleigh Hospital, Duke Cancer Institute, Durham, North Carolina.
  • Crawford J; Department of Medicine, Duke University School of Medicine, Durham, North Carolina.
  • Ready NE; Duke Raleigh Hospital, Duke Cancer Institute, Durham, North Carolina.
JTO Clin Res Rep ; 3(6): 100337, 2022 Jun.
Article em En | MEDLINE | ID: mdl-35719867
Introduction: Most patients with advanced NSCLC will experience disease progression and death within 2 years. Novel approaches are needed to improve outcomes. Methods: We conducted an open-label, nonrandomized, phase 2 trial in patients with treatment-naive, advanced NSCLC to assess the safety and efficacy of nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and four to six cycles of paclitaxel 80 mg/m2 on days 1 and 8 of every 21-day treatment. The primary end point of the study was median progression-free survival (PFS), with secondary end points of safety, objective response rate, and median overall survival (OS). Results: A total of 46 patients underwent consent and received treatment. The median age was 66 (range: 48-82) years, most had adenocarcinoma (63%), and 50% (23) had programmed death-ligand 1 greater than or equal to 1%. The median follow-up on the study as of October 2021 was 19 months. The primary end point of median PFS was 9.4 months (95% confidence interval [CI]: 5.9-16.6) in all patients regardless of programmed death-ligand 1 expression. The objective response rate for patients in the study was 47.8% (95% CI: 33.4-62.3). The 12-month OS rate was 69.5% (95% CI: 53%-81%), and median OS was not yet reached. Treatment-related grade greater than or equal to 3 adverse events was found in 54.3% of the patients. Conclusions: The toxicity observed was consistent with other reported chemo-immunotherapeutic combinations and was manageable. The primary end point of exceeding median PFS of 9 months was achieved with nivolumab, ipilimumab, and weekly paclitaxel and should be evaluated further in a randomized trial.
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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Ano de publicação: 2022 Tipo de documento: Article