Author of

• 20039

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  Poster Display Session (ID 63)

  • Event: ELCC 2017
  • Type: Poster Display Session
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1

  • 19896

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    140TiP - CheckMate 384: A phase 3b/4 dose-frequency optimization trial of nivolumab in advanced or metastatic non-small cell lung cancer (ID 261)

    12:30 - 12:30  |  Author(s): R. Harris
    • Abstract

    Background:
    Nivolumab, an anti-programmed death-1 antibody, is approved for the treatment of various cancers. Based on efficacy and safety findings across multiple tumor types, the approved dose of nivolumab was, until recently, 3 mg/kg every 2 weeks (Q2W). In September 2016, the approved nivolumab dose in non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma was modified in the United States to a flat dose of 240 mg Q2W. Reducing the frequency of nivolumab administration may increase convenience and compliance while maintaining efficacy and safety in patients receiving long-term nivolumab therapy. CheckMate 384, a randomized, open-label phase 3b/4 trial (NCT02713867) was designed to evaluate less frequent nivolumab dosing (480 mg every 4 weeks [Q4W] vs 240 mg Q2W) in patients with advanced/metastatic NSCLC following up to 12 months of prior treatment with nivolumab 3 mg/kg or 240 mg Q2W.
    
    Trial design:
    Eligible patients are adults with advanced/metastatic squamous or non-squamous NSCLC and Eastern Cooperative Oncology Group performance status 0–2 who received prior intravenous nivolumab 3 mg/kg or 240 mg Q2W for up to 12 months and achieved a complete or partial response or stable disease confirmed on 2 consecutive assessments. Patients with untreated, symptomatic central nervous system metastases are not eligible. Patients are randomized 1:1 to receive intravenous nivolumab in 1 of 2 flat-dose schedules: 240 mg Q2W or 480 mg Q4W. Randomization is stratified by histology and response to pre-study nivolumab treatment (complete/partial response vs stable disease). Endpoints are shown in the table. The primary objective is to compare 6-month and 1-year progression-free survival (PFS) rates between patients who received nivolumab 480 mg Q4W and those who received 240 mg Q2W. Planned enrollment is 620 patients.rnTable: 140TiPStudy endpointsrn

    rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn rnrn

    Primary	Secondary
    PFS rates at 6 months and 1 year after randomization (co-primary)	PFS rate at 1 year after randomization by tumor histology and by response to pre-study nivolumab before randomization
    	PFS rate at 2 years after randomization
    	Overall survival rate
    	Safety and tolerability, as assessed by incidence and severity of adverse events

    rn
    
    Clinical trial identification:
    NCT02713867
    
    Legal entity responsible for the study:
    Bristol-Myers Squibb
    
    Funding:
    Bristol-Myers Squibb
    
    Disclosure:
    N. Reinmuth: Personal fees (speakers and consulting honoraria): Bristol-Myers Squibb, Hoffmann-La Roche, Lilly, Novartis, Boehringer-Ingelheim, AstraZeneca, Amgen, Pfizer, MSD. R. Harris: Consultant (personal fees): Bristol-Myers Squibb. P. Mitchell: Advisory board member: AstraZeneca, Roche, Boehringer-Ingelheim, BMS, MSD, Celgene; Honoraria: Roche; Travel grants: Roche, BMS. E.B. Garon: Research Funding (received by my institution): AstraZeneca, BMS, Merck, Genentech, Eli Lilly, Pfizer, Novartis, Boehringer Ingelheim, Mirati. J. Zhu, I-F. Chang: BMS Employment and BMS Stock Ownership. S. Selvaggi: Bristol-Myers Squibb employee and shareholder and has received travel, accommodation, and expense assistance from Bristol-Myers Squibb. All other authors have declared no conflicts of interest.