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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4403 - A randomized, open-label, phase II open platform study evaluating the efficacy and safety of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma (PLATForM)

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Jeffrey Weber

Citation

Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289

Authors

J. Weber1, G.V. Long2, J.B. Haanen3, A. Arance4, R. Dummer5, P. Nathan6, A. Ribas7, P.A. Ascierto8, C. Robert9, E. Gasal10, A. D’Amelio Jr11, S. Bettinger12, A.D. Boran13, D. Schadendorf14

Author affiliations

  • 1 Laura And Isaac Perlmutter Cancer Center, NYU Langone Health, 10016 - New York/US
  • 2 Department Of Medical Oncology, Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney/AU
  • 3 Department Of Medical Oncology, Netherlands Cancer Institute, Amsterdam/NL
  • 4 Department Of Medical Oncology, Hospital Clinic of Barcelona, Barcelona/ES
  • 5 Department Of Dermatology, University Hospital Zürich Skin Cancer Center, Zürich/CH
  • 6 Mount Vernon Cancer Centre, East and North NHS Trust, Northwood/GB
  • 7 David Geffen School Of Medicine, The Jonsson Comprehensive Cancer Center, University of California, Los Angeles/US
  • 8 Cancer Immunotherapy And Innovative Therapies, Istituto Nazionale Tumori-IRCCS Fondazione "G. Pascale", Naples/IT
  • 9 Department Of Medicine, Institute Gustave Roussy, Paris/FR
  • 10 Global Clinical Program, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 11 Biostatistics, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 12 Global Clinical Program, Novartis Pharma AG, Basel/CH
  • 13 Oncology Precision Medicine, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 14 Department Of Dermatology, University Hospital Essen, Essen/DE
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Resources

Abstract 4403

Background

Significant advancements, including development of immune checkpoint inhibitors and targeted therapies, have transformed outcomes for patients (pts) with unresectable or metastatic melanoma. However, pts who do not respond or who progress while receiving these regimens have limited options. Spartalizumab (PDR001) is a high-affinity, humanized monoclonal antibody blocking the programmed cell death 1 (PD-1) receptor. This study is evaluating combinations of spartalizumab with novel compounds to restore antitumor T-cell activity in pts with melanoma progressing after prior PD-1 blockade therapy.

Trial design

This randomized, open-label, 2-part, multicenter, open platform, phase II study (NCT03484923; PLATforM) will evaluate safety and efficacy of spartalizumab combination treatment in pts with unresectable or metastatic melanoma progressing after prior anti–PD-1/L1 therapy and a BRAF inhibitor if the tumor harbors a BRAF V600 mutation. The primary endpoint will be objective response rate per RECIST v1.1, with duration of response and assessment of paired tumor biopsies for biomarkers of antitumor T-cell activity as part of the secondary endpoints. The first “selection” part of the study will begin with 3 combination arms: (1) spartalizumab + LAG525 (LAG-3 antibody), (2) spartalizumab + capmatinib (c-MET inhibitor), and (3) spartalizumab + canakinumab (IL-1β antagonist). For the selection part, the PLATforM study uses an adaptive design that, during the selection phase, allows dropping arms for futility, adding new arms, and selecting 1 or multiple arms for further expansion. Bayesian methodology is used with specific probability criteria for futility and efficacy assessments at each interim analysis. Pts (≈ 60-85) will be stratified by baseline lactate dehydrogenase level and randomized equally to all open arms during the selection part. In the second “expansion” part, efficacy and safety of treatment combination(s) selected during part one will be further investigated. Sample size for part two will be adaptive and based on predictive power calculations considering the results from the selection part.

Clinical trial identification

NCT03484923.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Editorial Acknowledgement

Medical writing assistance was provided by William Fazzone, PhD (ArticulateScience LLC), funded by Novartis Pharmaceuticals Corporation.

Disclosure

J. Weber: Honoraria: Novartis; Research funding paid to institution: Novartis. G.V. Long: Consultancy: Amgen, Bristol-Myers Squibb, Merck MSD, Novartis, Roche, Pierre Fabre, Array; Honoraria: Bristol-Myers Squibb, MSD, Roche, Novartis, Incyte. A. Arance: Honoraria and Speakers' bureau: Novartis, Roche, Bristol-Myers Squibb, MSD. R. Dummer: Intermittent, project focused consulting and/or advisory relationships: Novartis, Merck Sharp & Dhome (MSD), Bristol-Myers Squibb, Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma outside the submitted work. P. Nathan: Advisory board, Speakers' bureau, Honoraria: Novartis. A. Ribas: Stock ownership: Lutris, PACT, Tango; Advisory board member: Advaxis, Arcus, BioncoTech, Compugen, CytomX, Five Prime, FLX-Bio, ImaginAb, Isoplexis, Kite-Gilead, Rgenix; Honoraria: Amgen, Bristol-Myers Squibb, Chugai, Genentech, Merck, Novartis, Roche. P.A. Ascierto: Consultancy: Bristol-Myers Squibb, Roche-Genentech, MSD, Array, Novartis, Amgen, Merck-Serono, Pierre Fabre, Incyte, Genmab, Newlink Genetics, Medimmune, Syndax, AstraZeneca; Research funding: Bristol-Myers Squibb, Roche-Genetech, Array; Membership on Board of directors or Advisory committees: Bristol-Myers Squibb, Roche-Genentech, Array, Novartis. C. Robert: Advisory board participation: Merck, MSD, Novartis, Roche. E. Gasal: Employment and stock or other ownership: Novartis. A. D'Amelio Jr: Employment and stock ownership: Novartis. S. Bettinger, A.D. Boran: Employment: Novartis. D. Schadendorf: Personal fees: Amgen, Boehringer Ingelheim, Leo Pharma, Roche, Novartis, Incyte, Regeneron, 4SC, AstraZeneca, Bristol-Myers Squibb, MS, Pierre Fabre, Merck-EMD, Pfizer, Philiogen, Array; Patients' fees to institution: MSD, Roche, Novartis, Regeneron, Brisol-Myers Squibb, Merck-EMD, Philiogen. All other authors have declared no conflicts of interest.

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