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A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
Sponsor: MacroGenics
Summary
The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm). Lorigerlimab+docetaxel or docetaxel will be administered intravenously (IV) in clinic on Day 1 of each 3-week cycle. Prednisone will be administered orally twice daily. Lorigerlimab will be administered for up to 35 cycles. Docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI) and prostate-specific antigen (PSA) blood tests. Participants will be asked to complete questionnaires about their health and well-being. Routine examinations and blood tests will be performed and evaluated by the study doctor. Participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.
Official title: A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2023-09-28
Completion Date
2026-03
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
lorigerlimab
Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4
docetaxel
Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer
Prednisone
A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer
Locations (61)
United Medical Group
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Nebraska Cancer Specialists
Grand Island, Nebraska, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
START Mountain Region
West Valley City, Utah, United States
University of Virginia Health System Cancer Center
Charlottesville, Virginia, United States
Concord Repatriation General Hospital
Concord, Australia
Peter MacCallum Cancer Centre
North Melbourne, Australia
North Shore Private Hospital
St Leonards, Australia
Westmead Hospital
Westmead, Australia
Cliniques universitaires Saint-Luc (CUSL), Brussels
Brussels, Belgium
UZ GENT
Ghent, Belgium
Centre Hospital de l'Ardenne
Libramont, Belgium
CHU de Liège
Liège, Belgium
MHAT Dr. Tota Venkova
Gabrovo, Bulgaria
Comprehensive Cancer Center
Plovdiv, Bulgaria
UMHAT Sv. Ivan Rilski
Sofia, Bulgaria
Institut Bergonie
Bordeaux, France
Clinique Victor Hugo
Le Mans, France
Centre Léon Bérard
Lyon, France
Centre Antoine Lacassagne
Nice, France
Institut Mutualiste Montsouris
Paris, France
Centre Hospitalier Quimper
Quimper, France
CHP Saint Grégoire
Saint-Grégoire, France
Hia Begin
Saint-Mandé, France
Hopital Foch
Suresnes, France
Institut Gustave Roussy
Villejuif, France
LTD High Tech Hosp Medcenter
Batumi, Georgia
First University Clinic TSMU
Tbilisi, Georgia
LTD Consilium Medulla
Tbilisi, Georgia
Ltd Gidmedi
Tbilisi, Georgia
LtD L.M.National Urology Center
Tbilisi, Georgia
LTD MMT Hospital
Tbilisi, Georgia
LTD Todua Clinic
Tbilisi, Georgia
Onc. Scient. Research Center
Tbilisi, Georgia
Przychodnia Lekarska KOMED
Konin, Poland
Szpital Woj. im M Kopernika
Koszalin, Poland
Pratia McM Kraków
Krakow, Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
Otwock, Poland
LuxMed Onkologia
Warsaw, Poland
Medical Concierge
Warsaw, Poland
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., Oddział Chemioterapii
Warsaw, Poland
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico
H U Germans Tries i Pujol
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Parc Tauli
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
Institut Català d'Oncologia Hospitalet_ICO Hospitalet
Barcelona, Spain
Vall d' Hebron Institute of Oncology (VHIO)
Barcelona, Spain
Hospital 12 de octubre
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
FIVO: Instituto Valenciano de Oncología
Valencia, Spain
Churchill Hospital
Headington, United Kingdom
Charing Cross Hospital
London, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom