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ePoster Display

817TiP - GYNET study - Safety and efficacy of anti-netrin 1 (NP137) in combination with chemotherapy and/or pembrolizumab in patients (pts) with pretreated locally advanced/metastatic endometrial carcinoma or cervix carcinoma: An adaptive multi-arms randomized phase I/II trial


16 Sep 2021


ePoster Display


Cytotoxic Therapy;  Clinical Research;  Immunotherapy

Tumour Site

Endometrial Cancer;  Cervical Cancer


Isabelle Ray-Coquard


Annals of Oncology (2021) 32 (suppl_5): S725-S772. 10.1016/annonc/annonc703


I. Ray-Coquard1, P. Cassier2, S. Chabaud3, P. Mehlen4, A. Bernet5, F. Le Bras6, H. Gheit7, C. Angel8, C. Mastier9, B. Ducarouge10, T. De La Motte Rouge11, L. Gladieff12, A. Floquet13, M. Fabbro14, F. Joly15, M. Provansal Gross16, J. Frenel17, A. Leary18, D. Perol19, J. Blay20

Author affiliations

  • 1 Medical Oncology/gynecology Deparment, Centre Leon Berard Cancer center, 69008 - LYON/FR
  • 2 Department Of Medicine, Centre Léon Bérard, Lyon/FR
  • 3 Biostatistics And Therapeutics Evaluation Unit, Centre Léon Bérard, 69373 - Lyon/FR
  • 4 Research Department, Centre Léon Bérard, 69008 - Lyon/FR
  • 5 Research Department, CRCL, 69373 - LYON /FR
  • 6 Medical Department, Netris Pharma, 69373 - LYON /FR
  • 7 Drci, Centre Léon Bérard, 69373 - LYON /FR
  • 8 Clinical Research Pharmacy, Centre Léon Bérard, 69373 - LYON /FR
  • 9 Interventionnal Radiology, DeepLink Medical, 69002 - LYON /FR
  • 10 Research Department, Netris Pharma, 69373 - LYON /FR
  • 11 Medical Oncology Dept., Centre Eugene - Marquis, 35042 - Rennes/FR
  • 12 Medical Oncology Dept., Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 13 Department Of Medical Oncology - Gynecological Tumors, Institut Bergonié, Bordeaux/FR
  • 14 Department Of Medical Oncology, Institut du Cancer de Montpellier, 34000 - Montpellier/FR
  • 15 Medical Oncology, Centre Francois Baclesse, 14076 - Caen/FR
  • 16 Medical Oncology Dept., Institute Paoli Calmettes, 13009 - Marseille/FR
  • 17 Medical Oncology Dept., ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 18 Medical Oncology Dept., Institut Gustave Roussy, 94800 - Villejuif/FR
  • 19 Clinical Research Department, Centre Léon Bérard, 69008 - Lyon/FR
  • 20 Medicine Department, Centre Léon Bérard, 69008 - Lyon/FR


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Abstract 817TiP


NP137, a first-in-class humanized monoclonal antibody targeting netrin-1, by restoring apoptosis in tumor cells and by reversing tumoral epithelial to mesenchymal transition, able to promote response to chemotherapies and immunotherapies. NP137 has previously demonstrated in phase I monotherapy study a manageable safety profile and preliminary activity as a single agent in pts with gynecological carcinoma (NCT02977195).

Trial design

This multicenter, open label, multi-arms, randomized, Phase I/II investigates safety and clinical activity of NP137 combined with pembrolizumab and/or chemotherapy in in endometrial and cervix carcinoma. Eligible pts progressing/relapsing after 1 to 3 prior chemotherapy (CT) lines are randomly assigned (ratio 1:1:1:1) to one of the following arms: carboplatin + paclitaxel (standard regimen, Q3W, IV) alone; carboplatin + paclitaxel with NP137 (14 mg/kg, Q3W, IV); NP137 combined with Pembrolizumab (200 mg, Q3W, IV) and NP137 combined with Pembrolizumab and Carboplatin + Paclitaxel. Randomization is stratified according to the number of prior chemotherapy lines and the MSI/MSS status. A maximum of 30 pts will be enrolled in each arm for both tumor type cohort for a total sample size of 240 pts. A safety run is planned on first 6 to 12 pts in each arm to assess the safety of the therapeutic combinations. Primary endpoint is defined as the 3-month ORR assessed by an independent central review as per RECIST 1.1. An adaptive Bayesian approach will allow to quickly stop treatment cohorts without evidence of efficacy and/or select promising treatment cohorts. Secondary endpoints include Disease Control Rate, Duration of Response, Progression Free Survival, Overall Survival, pharmacokinetics and translational researches for biomarkers of efficacy and resistance. Enrollment started in December 2020. The triple combination arm will be opened once safety of double combinations is confirmed.

Clinical trial identification


Editorial acknowledgement

This study is granted by French National Research Agency (ANR-18-RHUS-0009) and sponsored by NETRIS Pharma in collaboration with Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and ARCAGY-GINECO group (The trial will be conducted with investigators of the ARCAGY-GINECO group. A list of the GYNET principal investigators is available on https://rhu-depgyn.com)

Legal entity responsible for the study

Netris Pharma.


Has not received any funding.


I. Ray-Coquard: Non-Financial Interests, Institutional, Advisory Board: Netris Pharma. P. Mehlen: Financial Interests, Personal and Institutional, Member of the Board of Directors: Netris Pharma. A. Bernet: Non-Financial Interests, Personal and Institutional, Other: Netris Pharma. F. le bras: Financial Interests, Institutional, Officer: Netris Pharma. C. Mastier: Financial Interests, Institutional, Research Grant: Netris Pharma. B. Ducarouge: Financial Interests, Institutional, Full or part-time Employment: Netris Pharma. D. Perol: Financial Interests, Institutional, Funding: Netris Pharma. J. Blay: Non-Financial Interests, Institutional, Advisory Board: Netris Pharma. All other authors have declared no conflicts of interest.

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