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  • Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician’s choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)

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Clinical trial
Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician’s choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)
  1. Lucia Musacchio1,
  2. Vanda Salutari1,
  3. Sandro Pignata2,
  4. Elena Braicu3,
  5. David Cibula4,
  6. Nicoletta Colombo5,
  7. Jean Sebastien Frenel6,
  8. Flora Zagouri7,
  9. Vittoria Carbone1,
  10. Viola Ghizzoni1,
  11. Serena Giolitto1,
  12. Elena Giudice1,
  13. Maria Teresa Perri1,
  14. Caterina Ricci1,
  15. Giovanni Scambia1,8 and
  16. Domenica Lorusso1,8
  1. 1 Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy
  2. 2 Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Naples, Italy
  3. 3 Department of Gynaecologic Oncology, Charité Universitätsmedizin Berlin, Berlin, Germany
  4. 4 Department of Obstetrics and Gynaecology, General University Hospital, Prague, Czech Republic
  5. 5 Gynecologic Oncology Program; European Institute of Oncology, IRCCS, University of Milan-Bicocca, Milan, Italy
  6. 6 Department of Medical Oncology, Institut de Cancerologie de l'Oust site Renè Gauducheau, Saint Herblain, France
  7. 7 Oncology Unit, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece
  8. 8 Department of Life Science and Public Health, Catholic University of Sacred Heart, Largo Agostino Gemelli, Rome, Italy
  1. Correspondence to Dr Domenica Lorusso, Policlinico Gemelli, Rome, Italy; domenica.lorusso{at}policlinicogemelli.it

Abstract

Background Platinum-resistant ovarian cancer patients have a poor prognosis and few treatment options are available. Preclinical and clinical data demonstrated that the combination of poly-ADP ribose polymerase inhibitors with immune checkpoint inhibitors could have a synergistic antitumor activity in this setting of patients.

Primary Objective The primary objective is to assess the efficacy of niraparib plus dostarlimab compared with chemotherapy in recurrent ovarian cancer patients not suitable for platinum treatment.

Study Hypothesis This trial will assess the hypothesis that niraparib plus dostarlimab therapy is effective to increase overall survival, progression-free survival, and time to first subsequent therapy respect to chemotherapy alone, with an acceptable toxicity profile.

Trial Design This is a phase III, multicenter trial, where recurrent ovarian cancer patients not eligible for platinum re-treatment will be randomized 1:1 to receive niraparib plus dostarlimab vs physician’s choice chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent. The study will be performed according to European Network for Gynaecological Oncological Trial groups (ENGOT) model B and patients will be recruited from 40 sites across MITO, CEEGOG, GINECO, HeCOG, MANGO, and NOGGO groups.

Major Inclusion/Exclusion criteria Eligible patients must have recurrent epithelial ovarian cancer not eligible for platinum retreatment. Patients who received previous treatment with poly-ADP ribose polymerase inhibitors and/or immune checkpoint inhibitors will be eligible. No more than two prior lines of treatment are allowed.

Primary Endpoint The primary endpoint is overall survival defined as the time from the randomization to the date of death by any cause.

Sample Size 427 patients will be randomized.

Estimated Dates for Completing Accrual and Presenting Results June 2024

Trial Registration Number NCT04679064.

  • ovarian cancer

Data availability statement

No data are available.

https://doi.org/10.1136/ijgc-2021-002593

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    Data availability statement

    No data are available.

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    Footnotes

    • LM and VS contributed equally.

    • Contributors Conceptualization: LM and DL; data curation: SG; writing original draft preparation: LM, VS, and DL; writing, review, and editing: all authors; visualization: all authors; supervision: DL and GS; project administration: DL.

    • Funding This study is funded by GSK.

    • Competing interests VS reports personal financial interest with Roche, Pharmamar, Astrazeneca, MSD, Clovis, Tesaro, GSK, and EISAI. SP reports honoraria from GSK, Roche, AstraZeneca, MSD, Clovis, and Pharmamar. EB reports funded research from EU, BMBF, AstraZeneca, Roche Diagnostics, Bayer, and MSD, honoraria/travels from Roche, Amgen, MSD, Clovis, AstraZeneca, Tesaro, GSK, and Roche Diagnostics, consulting/advisory board for Amgen, AstraZeneca, Clovis, Eisai, GSK, MSD, Tesaro, Roche, and Seattle Genetics. DC has been part of the advisory board of Roche, AstraZeneca, Merck, GSK, and Sotio. NC reports personal financial interest with Pharmamar, AstraZeneca, Roche, MSD/Merck, Clovis Oncology, Tesaro/GSK, Novartis, Pfizer, Takeda, Biocad, Immonogen, Mersana, and EISAI, and institutional financial interests (Research Grants) with AstraZeneca, Pharmamar, and Roche. JSF has been part of the advisory board of Novartis, Pfizer, AstraZeneca, Lilly, Roche, Biocad, Daiichi, Tesaro, GSK, and Pierre Fabre. FZ reports honoraria for lectures and advisory role for AstraZeneca, Daiichi, Eli-Lilly, Merck, Novartis, and Pfizer. GS reports Grant/Research Support by MSD and consultant for Tesaro, Johnson & Johnson, and AstraZeneca. DL reports personal financial interests (advisory roles) with AstraZeneca, Clovis Oncology, Merck, Roche, Tesaro-GSK, Amgen, and Pharmamar, and institutional financial interests (Study Grants) with Tesaro/GSK, Merck, Roche, Pharmamar, and Clovis. Board of Directors, and GCIG (Gynecologic Cancer Inter Group).

    • Provenance and peer review Commissioned; internally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.