A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT05848011
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
154 participants
INTERVENTIONAL
2023-09-28
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lorigerlimab + Docetaxel and Prednisone
Lorigerlimab 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).
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
Standard of care docetaxel and prednisone
Docetaxel 75 mg/m\^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months)
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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MacroGenics
INDUSTRY
Responsible Party
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Principal Investigators
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Denise Casey, M.D.
Role: STUDY_DIRECTOR
MacroGenics
Locations
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United Medical Group
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Nebraska Cancer Specialists
Grand Island, Nebraska, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Health System Cancer Center
Charlottesville, Virginia, United States
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
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
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
Pratia McM Kraków
Krakow, , Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
Otwock, , 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 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
Countries
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Other Identifiers
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CP-MGD019-02
Identifier Type: -
Identifier Source: org_study_id
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