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A phase III, randomized, double blinded trial of platinum based chemotherapy with or without atezolizumab followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal, or peritoneal cancer and platinum treatment free interval of more than 6 months: ENGOT-Ov41/GEICO 69-O/ANITA Trial
  1. Antonio Gonzalez Martin1,2,
  2. Luisa Sanchez Lorenzo1,
  3. Nicoletta Colombo3,
  4. René dePont Christensen4,
  5. Florian Heitz5,
  6. Mihai Meirovitz6,
  7. Frederic Selle7,
  8. Toon van Gorp8,
  9. Nuria Alvarez2,
  10. Javier Sanchez2 and
  11. Carmen Marqués2
  1. 1Medical Oncology, Clinica Universidad de Navarra, Madrid, Spain
  2. 2GEICO (Grupo Español de Investigación en Cáncer de Ovario), Madrid, Spain
  3. 3Medical Gynecologic Oncology Unit, University of Milan Bicocca, European Institute of Oncology IRCSS, Milano, Italy
  4. 4Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark
  5. 5Gynäkologie und Gynäkologische Onkologie, Evangelische Kliniken Essen-Mitte Klinik für, Essen, Germany
  6. 6Department of Gynecologic Oncology, Soroka University Medical Center and Ben Gurion University, Beer Sheva, Israel
  7. 7Service d'Oncologie Medicale, Groupe Hospitalier Diaconesses Croix Saint Simon and Alliance Pour la Recherche en Cancerologie, Paris, France
  8. 8Gynecologic Oncology, Universitair Ziekenhuis, Leuven, Belgium
  1. Correspondence to Dr Antonio Gonzalez Martin, Medical Oncology, Clinica Universidad de Navarra, Madrid 28027, Spain; agonzalezma{at}unav.es

Abstract

Background Platinum based chemotherapy is the treatment of choice for ovarian cancer patients with a platinum treatment free interval of >6 months. Niraparib is an oral poly (ADP-ribose) polymerase inhibitor approved as maintenance therapy after a response to platinum rechallenge, regardless of BRCA status. Atezolizumab is a humanized monoclonal antibody targeting programmed death-ligand 1 (PD-L1). A combination of poly (ADP-ribose) polymerase inhibitor and anti-PD-L1/programmed cell death protein 1 (PD-1) has shown synergy in preclinical models and promising clinical activity.

Primary objective To determine whether the addition of atezolizumab to carboplatin based chemotherapy and to subsequent maintenance with niraparib improves progression free survival compared with placebo in patients with recurrent disease and a platinum treatment free interval of >6 months.

Trial design The Atezolizumab and NIraparib Treatment Association (ANITA) trial is a GEICO (Grupo Español de Investigación en Cáncer de Ovario) led phase III, randomized, double-blinded, multicenter European Network for Gynecological Oncological Trials (ENGOT) study. Patients will be randomized to arm A (control arm) consisting of platinum based chemotherapy (investigator’s choice) plus a placebo of atezolizumab followed by maintenance niraparib plus a placebo of atezolizumab, or to arm B (experimental arm) consisting of platinum based chemotherapy (investigator’s choice) plus atezolizumab followed by maintenance niraparib plus atezolizumab.

Major inclusion/exclusion criteria Inclusion criteria are women aged over 18 years, diagnosed with relapsed high grade serous, endometrioid, or undifferentiated ovarian, fallopian tube, or primary peritoneal carcinoma. Patients are eligible if they received no more than two previous lines of chemotherapy, relapsed ≥6 months after the last platinum containing regimen, and have at least one measurable lesion according to the response evaluation criteria in solid tumors, version 1.1.

Primary endpoint The primary endpoint for this study is progression free survival.

Sample size Approximately 414 patients will be recruited and randomized in a 1:1 ratio, with the aim of demonstrating a benefit in progression free survival for the experimental arm with a hazard ratio of O.7, using a two sided alpha of 0.05 and a power of 80%.

Estimated dates for completing accrual and presenting results The trial was launched in the fourth quarter of 2018 and is estimated to close in the second quarter of 2021. Mature results for progression free survival are expected to be presented by 2023.

Trial registration Clinicaltrials.gov NCT03598270.

  • medical oncology

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Footnotes

  • Correction notice Since Online First publication, the third affiliation has been updated from

    'European Institute of Oncology' to

    'European Institute of Oncology IRCSS'.

  • Contributors All authors have read, reviewed, and approved the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement There are no data in this work.

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