Trial Title:
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT ID:
NCT05848011
Condition:
Androgen-Independent Prostatic Cancer
Androgen-Independent Prostatic Neoplasms
Prostate Cancer Recurrent
Androgen-Insensitive Prostatic Cance
Androgen-Resistant Prostatic Cancer
Hormone Refractory Prostatic Cancer
Immunotherapy
Immune Checkpoint Inhibitor
Inhibitory Checkpoint Molecule
Conditions: Official terms:
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Prednisone
Docetaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
lorigerlimab
Description:
Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4
Arm group label:
Lorigerlimab + Docetaxel and Prednisone
Other name:
MGD019
Intervention type:
Drug
Intervention name:
docetaxel
Description:
Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer
Arm group label:
Lorigerlimab + Docetaxel and Prednisone
Arm group label:
Standard of care docetaxel and prednisone
Other name:
Taxotere®
Intervention type:
Drug
Intervention name:
Prednisone
Description:
A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer
Arm group label:
Lorigerlimab + Docetaxel and Prednisone
Arm group label:
Standard of care docetaxel and prednisone
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Metastatic castration-resistant adenocarcinoma of the prostate without evidence of
neuroendocrine differentiation, signet cell, or small cell features.
- Participants must have ≥ 1 metastatic (measurable or non-measurable per PCWG3)
lesion.
- Participant has prostate cancer progression at study entry based on PCWG3 criteria.
- Participant shows evidence of disease progression after receiving at least 1 prior
androgen receptor axis-targeted therapy (ARAT) regimen (e.g., abiraterone,
enzalutamide, apalutamide, or darolutamide).
- Patients with known history of documented breast cancer gene (BRCA) mutation
(germline or somatic) must have received an approved poly ADP ribose polymerase
(PARP) inhibitor regimen.
- Participants must have adequate performance status, life expectancy and laboratory
values.
Exclusion Criteria:
- Any condition preventing participant's ability to receive, tolerate, or comply with
the planned treatment or study procedures.
- Received prior chemotherapy for mCRPC or checkpoint inhibitors for prostate cancer.
- Current active or chronic infections.
- Any clinically significant heart, lung, or gastrointestinal disorders.
- Allergy to any of the study treatments or components of the study treatments.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
United Medical Group
Address:
City:
Miami
Zip:
33135
Country:
United States
Status:
Terminated
Facility:
Name:
Orlando Health Cancer Institute
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Hatem Hassanein
Email:
Principal Investigator
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Daniel Fein
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Xiao Wei
Email:
Principal Investigator
Facility:
Name:
Nebraska Cancer Specialists
Address:
City:
Grand Island
Zip:
68803
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ralph Hauke, MD, FACP
Email:
Principal Investigator
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ashutosh Tewari
Email:
Principal Investigator
Facility:
Name:
SUNY Upstate Medical University
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alina Basnet
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Sumit Subudhi
Email:
Principal Investigator
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Joseph Call, MD
Email:
Principal Investigator
Facility:
Name:
University of Virginia Health System Cancer Center
Address:
City:
Charlottesville
Zip:
22903
Country:
United States
Status:
Recruiting
Investigator:
Last name:
William Skelton
Email:
Principal Investigator
Facility:
Name:
Concord Repatriation General Hospital
Address:
City:
Concord
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Anthony Linton
Email:
Principal Investigator
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
North Melbourne
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Shahneen Sandhu
Email:
Principal Investigator
Facility:
Name:
North Shore Private Hospital
Address:
City:
St Leonards
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Alexander Guminski
Email:
Principal Investigator
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Howard Gurney
Email:
Principal Investigator
Facility:
Name:
Cliniques universitaires Saint-Luc (CUSL), Brussels
Address:
City:
Brussel
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Jean Pascal Machiels
Email:
Principal Investigator
Facility:
Name:
UZ GENT
Address:
City:
Gent
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Sylvie Rottey
Email:
Principal Investigator
Facility:
Name:
Centre Hospital de l'Ardenne
Address:
City:
Libramont
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Frédéric Forget
Email:
Principal Investigator
Facility:
Name:
CHU de Liège
Address:
City:
Liège
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Brieuc Sautois
Email:
Principal Investigator
Facility:
Name:
MHAT Dr. Tota Venkova
Address:
City:
Gabrovo
Country:
Bulgaria
Status:
Recruiting
Investigator:
Last name:
Bonka Popova
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Center
Address:
City:
Plovdiv
Country:
Bulgaria
Status:
Recruiting
Investigator:
Last name:
Antoaneta Tomova
Email:
Principal Investigator
Facility:
Name:
UMHAT Sv. Ivan Rilski
Address:
City:
Sofia
Country:
Bulgaria
Status:
Recruiting
Investigator:
Last name:
Bozhil Robev
Email:
Principal Investigator
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Clinique Victor Hugo
Address:
City:
Le Mans
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Centre Hospitalier Quimper
Address:
City:
Quimper
Country:
France
Status:
Active, not recruiting
Facility:
Name:
CHP Saint Grégoire
Address:
City:
Saint-Grégoire
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Hia Begin
Address:
City:
Saint-Mandé
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Hopital Foch
Address:
City:
Suresnes
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Active, not recruiting
Facility:
Name:
LTD High Tech Hosp Medcenter
Address:
City:
Batumi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Tamta Makharadze
Email:
Principal Investigator
Facility:
Name:
First University Clinic TSMU
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
David Kochiashvili
Email:
Principal Investigator
Facility:
Name:
LTD Consilium Medulla
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Giorgi Adeishvili
Email:
Principal Investigator
Facility:
Name:
Ltd Gidmedi
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Aleksandre Khuskivadze
Email:
Principal Investigator
Facility:
Name:
LtD L.M.National Urology Center
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Archil Chkhotua
Email:
Principal Investigator
Facility:
Name:
LTD MMT Hospital
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Guram Karazanashvili
Email:
Principal Investigator
Facility:
Name:
LTD Todua Clinic
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Tamar Melkadze
Email:
Principal Investigator
Facility:
Name:
Onc. Scient. Research Center
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Amiran Matitashvili
Email:
Principal Investigator
Facility:
Name:
Przychodnia Lekarska KOMED
Address:
City:
Konin
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Bogusława Karaszewska
Email:
Principal Investigator
Facility:
Name:
Pratia McM Kraków
Address:
City:
Kraków
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Bożena Cybulska-Stopa
Email:
Principal Investigator
Facility:
Name:
Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
Address:
City:
Otwock
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Cezary Szczylik
Email:
Principal Investigator
Facility:
Name:
LuxMed Onkologia
Address:
City:
Warsaw
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Jakub Żołnierek
Email:
Principal Investigator
Facility:
Name:
Medical Concierge
Address:
City:
Warsaw
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Piotr Radziszewski
Email:
Principal Investigator
Facility:
Name:
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., Oddział Chemioterapii
Address:
City:
Warsaw
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Iwona Skoneczna
Email:
Principal Investigator
Facility:
Name:
Pan American Center for Oncology Trials, LLC
Address:
City:
Rio Piedras
Country:
Puerto Rico
Status:
Recruiting
Investigator:
Last name:
Josselyn Molina-Avila
Email:
Principal Investigator
Facility:
Name:
H U Germans Tries i Pujol
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Albert Font
Email:
Principal Investigator
Facility:
Name:
Hospital Clínic de Barcelona
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Begoña Mellado
Email:
Principal Investigator
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Alejo Rodríguez-Vida
Email:
Principal Investigator
Facility:
Name:
Hospital Parc Tauli
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Enrique Gallardo
Email:
Principal Investigator
Facility:
Name:
Hospital Sant Pau
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Jose Maroto
Email:
Principal Investigator
Facility:
Name:
Institut Català d'Oncologia Hospitalet_ICO Hospitalet
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Josep Maria Piulats
Email:
Principal Investigator
Facility:
Name:
Vall d' Hebron Institute of Oncology (VHIO)
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Irene Braña García
Email:
Principal Investigator
Facility:
Name:
Hospital 12 de octubre
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Elena Castro
Email:
Principal Investigator
Facility:
Name:
Hospital Beata Maria Ana
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Santiago Cabezas-Camarero
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Begona Pérez Valderrama
Email:
Principal Investigator
Facility:
Name:
FIVO: Instituto Valenciano de Oncología
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Maria Jose Juan Fita
Email:
Principal Investigator
Facility:
Name:
Churchill Hospital
Address:
City:
Headington
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Mark Tuthill
Email:
Principal Investigator
Facility:
Name:
Charing Cross Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Naveed Sarwar
Email:
Principal Investigator
Facility:
Name:
Royal Marsden Hospital
Address:
City:
Sutton
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Johann de Bono
Email:
Principal Investigator
Facility:
Name:
Musgrove Park Hospital
Address:
City:
Taunton
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Emma Gray
Email:
Principal Investigator
Start date:
September 28, 2023
Completion date:
September 2027
Lead sponsor:
Agency:
MacroGenics
Agency class:
Industry
Source:
MacroGenics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05848011
