A Phase 2, Randomized, Open-Label, Study of lorigerlimab with docetaxel or docetaxel alone in Participants with Metastatic Castration-Resistant Prostate Cancer

UVA Tracking #
Principal Investigator
William Paul Skelton Iv
Contact Phone
Official Trial Title
A Phase 2, Randomized, Open-Label, Study of Lorigerlimab with Docetaxel or Docetaxel Alone in Participants with Metastatic Castration-Resistant Prostate Cancer
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with metastatic castration-resistant prostate cancer (mCRPC) to participate in a research study. This research study involves three drugs. The investigational drug is called lorigerlimab (also known as MGD019). An investigational drug means the drug is not approved for the use being tested by any government office that controls new drugs, like the US Food and Drug Administration (FDA). The other two drugs are called docetaxel and prednisone. The combination of docetaxel and prednisone is an approved standard treatment regimen for mCRPC. If you enroll in this study, you may receive lorigerlimab in combination with docetaxel and prednisone or you may receive standard of care docetaxel and prednisone without lorigerlimab. The purpose of this study is to test the safety and efficacy of lorigerlimab in men with prostate cancer. Lorigerlimab is an immunotherapy treatment. Immunotherapy drugs change how a person’s immune system works so that it may be used to fight cancer or other diseases.

The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the study doctor. If you are eligible for the study and consent to participate, your involvement includes a screening visit, a treatment period of up to two years where you receive the study drugs at the end of each cycle (3 weeks), an end of study treatment visit, and a follow up period to keep track of how you are doing. How long you will be on the study depends on your ability to safely tolerate the study treatment, your response to study treatment, and your and/or your study doctor’s decision for you to continue study treatment.

The study drugs, lorigerlimab, docetaxel, and prednisone, will be provided by the sponsor at no cost to you. All additional study procedures, including laboratory tests, physical examinations, and visits to the study center are provided to you at no charge.

Additional information can be found here: https://www.clinicaltrials.gov/study/NCT05848011



$65 Stipend per visit Hotel Reimbursement – Up to $200 per night