GYNecological Cancers Treated With NETrin mAbs in Combination With Chemotherapy and /or Pembrolizumab — GYNET

Endometrial Carcinoma Clinical Trial

Official title:
A Randomized, Multicenter, Open Label, Phase I/II Study to Evaluate the Safety, Clinical and Biological Activity of a Humanized Monoclonal Antibody Targeting Netrin-1 (NP137) in Combination With Carboplatin Plus Paclitaxel and/or Pembrolizumab in Patients With Locally Advanced/Metastatic Endometrial Carcinoma or Cervix Carcinoma Progressing/Relapsing After at Least One Prior Systemic Chemotherapy.

Status Recruiting

Clinical Trial Summary

The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with pembrolizumab and/or chemotherapies in patients with advanced/metastatic gynecological cancers (2 types: endometrial carcinoma and cervix carcinoma).

Clinical Trial Description

The prognosis of patients with locally advanced/metastatic uterine (endometrial or cervical) cancer progressing/relapsing after at least one prior systemic treatment remains poor. The development of new innovative anti-tumor drug candidates as single agent or in combination with chemotherapy or check point inhibitors is needed. NP137 is a first-in-class humanized monoclonal antibody targeting specifically and selectively Netrin-1. By blocking Netrin-1, NP137 is capable of restoring apoptosis in tumor cells in vitro and in vivo, leading to therapeutic activity in various animal cancer models. Dependence receptors inhibitor such as NP137 might be a novel choice to improve the clinical outcomes of these patients. The herein proposed study will be a multicenter, open-label, randomized, Phase I/II trial with: A safety run in part to assess the safety of the therapeutic combinations for the first 6 patients enrolled in each of the therapeutic combinations independently of the tumor type. According to safety rules, these therapeutic combinations will be investigated or not in the Phase II part. A Phase II part will be then conducted using an adaptive Bayesian approach allowing to quickly stop treatment cohorts without evidence of efficacy and/or select promising treatment cohorts. The Phase II part will be initiated with a preliminary step to assess the clinical activity of the proposed therapeutic combinations in 2 tumor types before proceeding to the activation of extension phase II part of the study. For each cohorts, clinical activity will be assessed through by sequential statistical analysis at specific timepoints. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04652076
Study type	Interventional
Source	NETRIS Pharma
Contact	Ray-Coquard Isabelle, MD, PhD
Phone	+33(0)4 78 78 28 28
Email	isabelle.ray-coquard@lyon.unicancer.fr
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	December 14, 2020
Completion date	July 30, 2026

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