A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
1 other identifier
interventional
154
10 countries
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2023
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedStudy Start
First participant enrolled
September 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2026
CompletedApril 17, 2026
April 1, 2026
2.4 years
April 17, 2023
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Median radiographic progression free survival (rPFS) determined by investigator review.
The rPFS is defined as the time from the date of randomization to the date of first documented PD per Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first.
Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
Secondary Outcomes (21)
Objective response rate (ORR) per PCWG3 criteria
Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
Duration of response (DoR)
Every 9 weeks for the first year, then every 12 weeks for up to 4 years
Time to response (TTR)
Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
PSA50 response rate
Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
PSA90 response rate
Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
- +16 more secondary outcomes
Study Arms (2)
Lorigerlimab + Docetaxel and Prednisone
EXPERIMENTALLorigerlimab 6 mg/kg IV (up to 2 years) and docetaxel 75 mg/m\^2 IV every 3 weeks (up to 7 months) and prednisone 5 mg orally twice daily (up to 7 months).
Standard of care docetaxel and prednisone
OTHERDocetaxel 75 mg/m\^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months)
Interventions
Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4
Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer
A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MacroGenicslead
Study Sites (61)
United Medical Group
Miami, Florida, 33135, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Nebraska Cancer Specialists
Grand Island, Nebraska, 68803, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
START Mountain Region
West Valley City, Utah, 84119, United States
University of Virginia Health System Cancer Center
Charlottesville, Virginia, 22903, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Denise Casey, M.D.
MacroGenics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2023
First Posted
May 8, 2023
Study Start
September 28, 2023
Primary Completion
February 19, 2026
Study Completion
March 16, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share