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Poster Display session 2

4155 - Durvalumab plus Tremelimumab for the Treatment of Patients (pts) with Refractory and Progressive Advanced Thyroid Carcinoma. A Phase II Multicohort Trial (DUTHY / GETNE T1812)

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Jorge Hernando Cubero

Citation

Annals of Oncology (2019) 30 (suppl_5): v756-v759. 10.1093/annonc/mdz267

Authors

J. Hernando Cubero1, M. Taberna Sanz2, A. Carmona Bayonas3, L. Iglesias4, E. Grande5, J.M. Trigo Perez6, J.J. Grau7, J.M. Lopez-Picazo8, B. Castelo9, T. Alonso Gordoa10, I. Lorenzo11, A. Casado Herraez12, L. Ugidos13, J. Munarriz14, J. Lavernia15, J. Capdevila1

Author affiliations

  • 1 Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 2 Medical Oncology, ICO - Institut Catala d'Oncologia Hospital Duran i Reynals, 08907 - Hospitalet de Llobregat/ES
  • 3 Hematology And Medical Oncology, Hospital Universitario Morales Meseguer, 30008 - Murcia/ES
  • 4 Oncology, University Hospital 12 de Octubre, Madrid/ES
  • 5 Head Of Medical Oncology Department, MD Anderson Cancer Center Madrid, 28033 - Madrid/ES
  • 6 Medical Oncology, Hospital Universitario Virgen de la Victoria, 29010 - Málaga/ES
  • 7 Medical Oncology, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 8 Medical Oncology, Clínica Universidad de Navarra, Pamplona/ES
  • 9 Medical Oncology, Hospital Universitario La Paz, 28046 - Madrid/ES
  • 10 Medical Oncology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 11 Medical Oncology, Complejo Hospitalario Universitario de Vigo, Vigo/ES
  • 12 Department Of Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 13 Medical Oncology, HM San Chinarro, Madrid/ES
  • 14 Medical Oncology, Hospital General de Castellón, 12004 - Castellón/ES
  • 15 Medical Oncology, Hospital General Universitario Valencia, 46014 - Valencia/ES
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Resources

Abstract 4155

Background

Preliminary studies have suggested that the activity of anti-PD-1 immune check-point inhibitors in thyroid cancer is low. However, we hypothesize that combining CTLA-4 and PD-L1 clockade could have a higher effet in the setting of refractory thyroid carcinomas, in which the process of de-differentiation and evasive tumor resistance are associated with increased mutational load.

Trial design

This prospective, multi-center, open-label, phase II study will evaluate the efficacy and safety of Durvalumab plus Tremelimumab within three parallel cohorts: differentiated (DTC), medullary (MTC), and anaplastic (ATC) thyroid cancers. Pts will receive Durvalumab 1500mg plus Tremelimumab 75mg every 4 weeks for up to 4 cycles followed by Durvalumab until PD, unacceptable toxicity or patients’ decision. Main end point in cohorts 1 and 2 is progression-free survival (PFS). We hypothesize an increase of 6-months from 25% in historical cohorts up to 45%. A Simon two-stage design will be employed with 17 pts per cohort in the first phase. If 5/17 pts in each cohort (DTC and MTC) are event free and without unacceptable toxicity at 6 months in the first stage, 19 additional pts will be reruited up to 36 pts per cohort. For cohort 3 (ATC), we hypothesize an improvement the probability of being alive at 6 months from 5% in historical cohorts up to 35%. 12 pts are needed in this cohort. Secondary objectives include overall response rate by irRECIST and RECIST, duration of response, safety profile and biomarkers. The main inclusion criteria for the three cohorts are: Cohort 1: Pts with locally advanced or metastatic DTC after PD on multikinase inhibitors (MKIs). Cohort 2: Pts with locally advanced or metastatic MTC after PD to MKIs. Cohort 3: Pts with ATC irrespective of prior therapy. No prior treatment with immune checkpoint inhibitors is allowed. The study is currently recruiting pts with 6 out of 46 planned pts enrolled at time of submission.

Clinical trial identification

EudraCT: 2018-001066-42.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Spanish Group of Neuroendocrine and Endocrine Tumors (GETNE).

Disclosure

J. Hernando Cubero: Speaker Bureau / Expert testimony: Eisai, Ipsen, Roche, Angelini; Travel / Accommodation / Expenses: Ipsen, Novartis, AAA, Roche, AstraZeneca, Eisai. M. Taberna Sanz: Advisory / Consultancy: Merck, Nanobiotics, AstraZeneca, MSD and Bristol Myers..A. Carmona Bayonas: Speaker Bureau / Expert testimony: Novartis, Ipsen; Travel / Accommodation / Expenses: Novartis, Ipsen. L. Iglesias: Advisory / Consultancy: Merck Serono, MSD, BMS, Bayer and Sanofi; Speaker Bureau / Expert testimony: Merck Serono, MSD, AstraZeneca and BMS..E. Grande: Advisory / Consultancy: Pfizer, Ipsen, BMS, Eisai, Roche, MSD, Sanofi, Adacap, Novartis, EUSA Pharma, Pierre Fabre, Lexicon, Celgene; Research grant / Funding (institution): MSD, Roche. J.M. Trigo Perez: Advisory / Consultancy: BMS, MSD, Behringer, GSK; Speaker Bureau / Expert testimony: AstraZeneca, Bayer, Roche; Travel / Accommodation / Expenses: MSD, BMS. T. Alonso Gordoa: Advisory / Consultancy: BMS, MSD, Roche, Astellas, IPSEN, Sanofi; Speaker Bureau / Expert testimony: Pfizer, Ipsen, Janssen, Astellas, Novartis.; Research grant / Funding (self): Roche; Travel / Accommodation / Expenses: Pfizer, Sanofi. J. Lavernia: Speaker Bureau / Expert testimony: Roche, BMS, Sun Pharma, Sanofi and Merck Serono. J. Capdevila: Advisory / Consultancy: Novartis, Pfizer, Ipsen, Exelixis, Bayer, Eisai, AAA, Amgen, Sanofi, Merck; Honoraria (institution): Eisai, Novartis, Ipsen, AstraZeneca, Pfizer, AAA. All other authors have declared no conflicts of interest.

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