193TiP - CheckMate 171: A multicenter phase 2 trial of nivolumab (nivo) in patients (pts) with stage IIIB/IV squamous cell (SQ) NSCLC who have received ≥1 p...

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Poster lunch
Topics Immunotherapy
Non-small-cell lung cancer
Therapy
Presenter Enriqueta Felip
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors E. Felip1, J. Van Meerbeeck2, J. Wolf3, A. Ardizzoni4, A. Li5, S. Srinivasan6, S. Popat7
  • 1Oncologia Médica, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 2Thoraxoncologie, Universitair Ziekenhuis Antwerpen, Antwerp/BE
  • 3Center For Integrated Oncology Köln-bonn, University Hospital of Köln, Cologne/DE
  • 4Medical Oncology, UOC Oncologia Medica, Parma/IT
  • 5Global Biometric Sciences/statistical Programming And Technologies, Bristol-Myers Squibb, Princeton/US
  • 6Medical Affairs, Bristol-Myers Squibb, Princeton/US
  • 7Department Of Medicine, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB

Abstract

Background

Treatment options are limited for pts with advanced SQ NSCLC who fail platinum-based doublet chemotherapy (PT-DC). Nivo, a fully human IgG4 programmed death-1 immune checkpoint inhibitor, is approved in the United States (US) for the treatment of pts with metastatic NSCLC whose disease has progressed on or after PT-DC, and in the European Union (EU) for pts with locally advanced or metastatic SQ NSCLC after prior chemotherapy. Nivo has demonstrated survival benefit across multiple tumor types. In two randomized phase 3 trials in advanced SQ (CheckMate 017) and non-SQ (CheckMate 057) NSCLC, nivo has demonstrated superior survival and favorable safety compared to docetaxel. CheckMate 153, a US community-based phase 3B/4 safety trial, evaluates nivo monotherapy in pts with advanced/metastatic NSCLC. Early data from CheckMate 153 have shown a manageable safety profile consistent with previously reported clinical trial results. This EU-based safety trial (CheckMate 171) evaluates nivo monotherapy in pts with advanced/metastatic SQ NSCLC.

Trial design

Adult pts with SQ NSCLC, disease progression or recurrence on or after one prior PT-DC regimen, ECOG PS 0–2, measurable disease per RECIST v1.1 criteria, and treated or asymptomatic central nervous system (CNS) metastases are eligible. Pts with untreated or symptomatic CNS metastases, carcinomatous meningitis, or autoimmune disease, and pts who received any drug targeting T-cell costimulation or checkpoint pathways are ineligible. The primary endpoint is incidence of grade 3–4 treatment-related select Aes. Secondary endpoints include the incidence of all grade 3–4 select Aes, median time to onset and resolution of grade 3–4 select AEs, overall survival, and investigator-assessed objective response rate. Pts will be enrolled into two subgroups (ECOG PS 0–1 and 2), and 800 pts are estimated to be treated. Study duration is 5 years.

Clinical trial identification

NCT02409368

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

E. Felip: Personal fees from Eli Lilly, Pfizer, Roche, Boehringer Ingelheim, Astra Zeneca, Bristol-Myers Squibb, Merck Sharp & Dohme, and Novartis. J. Wolf: Personal fees for advisory board lecture fees from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Clovis, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. A. Ardizzoni: Honoraria from BMS for Advisory Board participation. A. Li: Dr. Employee of Bristol-Myers Squibb; he also reports stock ownership in Bristol-Myers Squibb. S. Popat: Personal fees from Eli Lilly and grants from Pierre Fabre, and is a non-compensated consultant to Ariad, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis Oncology, and Merck Sharp & Dohme. All other authors have declared no conflicts of interest.