Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
Condition(s) studied
Investigational drug(s) / intervention(s)
Emactuzumab: Emactuzumab administered once every 2 weeks (q2w)
Placebo: Matching placebo administered once every 2 weeks (q2w)
Study summary
This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the treatment of patients with localized or diffuse TGCT where surgical removal of the tumor is not viewed as an option.
The study consists of two parts. In Part 1, eligible subjects will be assigned in a 2:1 ratio to receive either emactuzumab or matching placebo in a double-blind fashion, that will be administered in total 5 times as an intravenous (i.v.) infusion once every 2 weeks. This will be followed by an observation period of 3 months leading to a total duration of 24 weeks in Part 1. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. Part 2 is a long-term double-blind follow-up phase of the subjects on emactuzumab or placebo. Subjects assigned to placebo in Part 1 have the option, subject to eligibility, to crossover to receive open-label emactuzumab in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances.
Eligibility
Primary outcome measure(s)
- Overall Response Rate (ORR) — Day 0 - Day 180 (6 months)
Objective Response Rate (ORR = complete response \[CR\] + partial response \[PR\]) by 6 months from initiation of therapy according to RECIST v1.1 based on independent, blinded central review
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| NextGen Oncology | Beverly Hills | California | |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | |
| The Ohio State University | Columbus | Ohio | |
| MD Anderson Cancer Center | Houston | Texas | |
| MedStar Washington Hospital Center | Georgetown | Washington | |
| Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert | Brussels Capital | |
| Arthur J.E. Child Comprehensive Cancer Centre | Calgary | Alberta | |
| Princess Margaret Cancer Centre | Toronto | Ontario | |
| McGill University Health Centre (MUHC) | Montreal | Quebec | |
| Institut Bergonie - PPDS | Bordeaux | Gironde | |
| Institut de Cancerologie de Ouest - Saint Herblain | Saint-Herblain | Loire-Atlantique | |
| AP-HP - Hôpital Cochin - Port-Royal, site Cochin | Paris | Paris | |
| Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes | Lyon | Rhône | |
| UNICANCER - Centre Oscar Lambret | Lille | France | |
| Institut Curie - Hôpital de Paris | Paris | France | |
| Oncopole Claudius Regaud Oncologie Médicale | Toulouse | France | |
| Fondazione Policlinico Universitario Campus Bio-Medico | Rome | Lazio | |
| Istituti Fisioterapici Ospitalieri - IRCCS Istituto Nazionale Tumori Regina Elena | Rome | Lazio | |
| Fondazione del Piemonte per l'Oncologia (IRCCS) | Candiolo | Piedmont | |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo | Sicily | |
| IRCCS lstituto Ortopedico Rizzoli | Bologna | Italy | |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy | |
| Leids Universitair Medisch Centrum | Leiden | Netherlands | |
| Seoul National University Hospital | Seoul | South Korea | |
| Hospital Universitario Fundacion Jimenez Diaz | Zaragoza | Zaragoza | |
| Hospital de La Santa Creu i Sant Pau | Barcelona | Spain | |
| Hospital Universitario Virgen del Rocio - PPDS | Seville | Spain | |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Spain | |
| Skanes Universitetssjukhus Lund | Lund | Skåne County | |
| Universitäts Kinderspital Beider Basel (UKBB) | Basel | Switzerland | |
| Taipei Veterans General Hospital | Taipei | Taiwan | |
| St James's University Hospital | Leeds | United Kingdom | |
| University College Hospital | London | United Kingdom |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05417789 on ClinicalTrials.gov ↗ ← All trials in Italy