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W. Hu

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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
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      138TiP - An open-label phase 3b/4 safety trial of flat-dose nivolumab plus ipilimumab in patients with advanced non-small cell lung cancer (NSCLC) (ID 164)

      12:30 - 13:00  |  Author(s): W. Hu

      • Abstract

      The combination of nivolumab and ipilimumab, immune checkpoint inhibitors with distinct but complementary mechanisms of action, is approved as first-line therapy for metastatic melanoma and has shown encouraging clinical activity in other tumors, including NSCLC. In CheckMate 012, a multi-cohort phase 1 trial in chemotherapy-naïve patients with NSCLC, nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) yielded objective response rates of up to 47%; discontinuation rates due to treatment-related adverse events were similar to those with nivolumab monotherapy. Data indicate comparable pharmacokinetic, safety, and efficacy profiles for 240 mg flat-dose nivolumab and 3 mg/kg nivolumab. This open-label phase 3b/4 study ( identifier: NCT02869789) will characterize the safety of flat-dose nivolumab plus ipilimumab in patients with advanced NSCLC. This study will also evaluate this combination in special patient populations who are typically excluded from NSCLC trials.

      Trial design:
      Adult patients with stage IV/recurrent NSCLC and no prior systemic anticancer therapy (cohort A; n = 400), or with stage IIIb/IV NSCLC and recurrence or progression during or after one prior platinum doublet chemotherapy regimen (cohort B; n = 400) will be enrolled. Patients are required to have assessment of programmed death-1 ligand 1 expression, Eastern Cooperative Oncology Group performance status (ECOG PS) 0–1, and no untreated brain metastases, carcinomatous meningitis, autoimmune disease, or active malignancy requiring concurrent intervention. A third cohort (A1; n = ∼200) with no prior systemic therapy will have ECOG PS 2 or one or more of the following: asymptomatic untreated brain metastases, renal or hepatic dysfunction, and/or HIV. All patients will receive flat-dose nivolumab (240 mg every 2 weeks) plus weight-based ipilimumab (1 mg/kg every 6 weeks). Endpoints are shown in the table.rnTable: 138 TiPStudy endpointsrn

      rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn rnrn
      Number and percentage of patients with high-grade treatment-related select and immune-mediated adverse eventsProgression-free survival
      Objective response rate
      Duration of response
      Patient-reported outcomes based on the Functional Assessment of Cancer Therapy-Lung (FACT-L)

      Clinical trial identification:

      Legal entity responsible for the study:
      Bristol-Myers Squibb

      Bristol-Myers Squibb

      L. Paz-Ares: Medical advisor for: Lilly, Roche, MSD, BMS, Celgene, Pfizer, Boehringer Ingelheim, Bayer, Clovis, and Astra Zeneca. C. Chakmakjian: Speaker\'s Bureau for: BMS. N. Ready: Honoraria from: BMS, Merck; Consultant for: BMS, Merck, Novartis, Abbvie. W. Hu, L. Krug, J. Fairchild: Bristol-Myers Squibb employee. All other authors have declared no conflicts of interest.