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E-Poster Display

1443P - Modified FOLFOX versus modified FOLFOX plus nivolumab and ipilimumab in patients with previously untreated advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction – Safety Results from AIO-STO-0417: A randomized phase II trial of the German Gastric Group of the AIO

Date

17 Sep 2020

Session

E-Poster Display

Topics

Immunotherapy

Tumour Site

Gastric Cancer

Presenters

Claudia Pauligk

Citation

Annals of Oncology (2020) 31 (suppl_4): S841-S873. 10.1016/annonc/annonc284

Authors

C. Pauligk1, T.O. Götze2, P.C. Thuss-Patience3, J. Riera-Knorrenschild4, E. Goekkurt5, T.J. Ettrich6, D. Pink7, U. Lindig8, K.B. Luley9, T. Dechow10, M. Bitzer11, S. Angermeier12, N. Homann13, F. Kullmann14, G. Schuch15, C. Bolling16, S. Junge1, R.D. Hofheinz17, S. Lorenzen18, S. Al-Batran1

Author affiliations

  • 1 Ikf, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, 60488 - Frankfurt am Main/DE
  • 2 Krankenhaus Nordwest Uct Frankfurt, Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, 60488 - Frankfurt/DE
  • 3 Department Of Haematology, Oncology And Tumorimmunology, Charité–University Medicine Berlin, Berlin/DE
  • 4 Hematology And Oncology, Universitätsklinikum, Giessen und Marburg, Marburg/DE
  • 5 Hematology-oncology Practice Hamburg (hope), Facharztzentrum Eppendorf, 20249 - Hamburg/DE
  • 6 Department Of Internal Medicine I, Ulm Medical University, 89081 - Ulm/DE
  • 7 Klinik Für Hämatologie, Onkologie Und Palliativmedizin, Sarkomzentrum Berlin-brandenburg, Klinik und Poliklinik für Innere Medizin C, Hämatologie und Onkologie, Transplantationszentrum, Palliativmedizin, Universität Greifswald and HELIOS Klinikum Bad Saarow, 15526 - Bad Saarow/DE
  • 8 Department For Internal Medicine Ii, University Hospital Jena, Friedrich-Schiller-University, 07747 - Jena/DE
  • 9 Hematology And Oncology, University Hospital Schleswig-Holstein, Luebeck/DE
  • 10 Ravensburg, Onkologie Hematologie, 88212 - Ravensburg/DE
  • 11 Medizinische Klinik I, Universitätsklinikum Tübingen,, Tuebingen/DE
  • 12 Medizinische Klinik I, Klinikum Ludwigsburg, Ludwigsburg/DE
  • 13 Med. Klinik Ii, Klinikum Wolfsburg, 38440 - Wolfsburg/DE
  • 14 Academic Teaching Hospital Weiden, Department of Internal Medicine I,, Weiden/DE
  • 15 Hematology And Oncology, Hämatologisch-Onkologische Praxis Altona (HOPA), Hamburg/DE
  • 16 Onkologie / Hämatologie, Agaplesion Markus Hospital, Frankfurt am Main/DE
  • 17 Interdisciplinary Tumor Center, UMM - Universitaetsklinikum Mannheim, 68167 - Mannheim/DE
  • 18 Clinic And Policlinic For Internal Medicine Iii, Technical University Munich, School of Medicine, 81675 - Munich/DE

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Abstract 1443P

Background

Oxaliplatin-based regimens are standard of care in first-line (1L) treatment of patients (pts) with advanced gastroesophageal cancer (GEC). However, median survival is still below 12 months. Results from trials using nivolumab (nivo) plus ipilimumab (ipi) treatment of pts with advanced GEC demonstrated clinical activity. The AIO-STO-0417 trial (Moonlight) evaluates the combination of FOLFOX with Nivo and Ipi as 1L-treatment.

Methods

This is a prospective, multicenter, randomized, investigator-initiated phase II trial. Pts with Her2-negative, inoperable, advanced or metastatic GEC were randomized 1:1 to FOLFOX (Oxaliplatin 85 mg/m2; Leucovorin 400 mg/m2; 5FU 400 mg/m2 on d1 of each treatment cycle and 5FU 2400 mg/m2 continuous infusion over 44 hrs) every 2 weeks plus Nivolumab 240 mg every 2 weeks and Ipilimumab 1mg/kg every 6 weeks (Arm A) or FOLFOX alone (Arm B). Primary endpoint is progression free survival; safety is a major secondary endpoint which was preliminary analysed here.

Results

119 pts (60 Arm A, 59 Arm B) were included in the current analysis, 116 pts within the safety population (59/57). Pts were treated with a median of 9 cycles in arm A versus 8 cycles in arm B. Therapy was delayed at least once in 67% of arm A vs 58% arm B. Premature discontinuation because of toxicity/pts wish was 10% in arm A vs 17% in arm B. More pts in the nivo/ipi arm had ≥ grade 3 adverse events (AEs) related to study therapy (76% vs 39%) and treatment related SAEs (54% vs 23%). However, the latter did not result in more fatal outcomes in arm A (6.8% vs 5.3 % in arm B). Relevant ≥ grade 3 AEs in arm A vs Arm B were neutropenia 31% (febrile: 5%) and 10% (febrile: none) and sepsis 7% vs 2%.

Conclusions

Combination of FOLFOX and Nivo and Ipi is tolerable and feasible. As expected, toxicity rates increased by addition of immunotherapy, but this did not result in remarkably higher premature discontinuation or fatal outcomes. After amendment, the trial will compare FOLFOX in combination with Nivo and Ipi concurrently vs. a sequential cohort with alternating FOLFOX and immunotherapy.

Clinical trial identification

NCT03647969.

Editorial acknowledgement

Legal entity responsible for the study

Institut für Klinische Krebsforschung IKF GmbH.

Funding

BMS.

Disclosure

T.O. Götze: Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Bayer; Advisory/Consultancy: Servier; Advisory/Consultancy: Roche; Research grant/Funding (self): Deutsche Forschungsgemeinschaft; Research grant/Funding (self): Gemeinsamer Bundesausschuss. E. Goekkurt: Advisory/Consultancy: MSD; Advisory/Consultancy: Servier; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi. D. Pink: Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Research grant/Funding (institution): Clinigen Group; Advisory/Consultancy, Research grant/Funding (institution): Roche; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): PharmaMar. R.D. Hofheinz: Honoraria (self): Bristol-Myers Squibb. S-E. Al-Batran: Advisory/Consultancy: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Lilly; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (self): Merck; Advisory/Consultancy, Speaker Bureau/Expert testimony: Nordic Bioscience; Advisory/Consultancy: Merck Sharp & Dohme; Speaker Bureau/Expert testimony: AIO gGmbH; Speaker Bureau/Expert testimony: Forum für Medizinische Fortbildung; Speaker Bureau/Expert testimony: MCI group; Research grant/Funding (self): Medac; Research grant/Funding (self): Hospira; Research grant/Funding (self): Sanofi; Research grant/Funding (self): German Cancer Aid; Research grant/Funding (self): German Research Foundation; Research grant/Funding (self): Federal Ministry of Education and Research; Research grant/Funding (self): Vifor Pharma. All other authors have declared no conflicts of interest.

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