A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05848011

Run by

MacroGenics

People needed

154

Starts

2023-09-28

Expected to finish

2026-03-16

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• 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
• LTD Consilium Medulla — Tbilisi, Georgia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.