CP-MGD019-02
Research type
Research Study
Full title
A Phase 2, Randomized, Open-Label, Study of Lorigerlimab with Docetaxel or Docetaxel Alone in Participants with Metastatic Castration-Resistant Prostate Cancer
IRAS ID
1008121
Contact name
Katie Grossi
Sponsor organisation
MacroGenics, Inc.
Eudract number
2022-502982-49
Clinicaltrials.gov Identifier
Research summary
Study to test the safety and efficacy of lorigerlimab in metastatic castration-resistant prostate cancer (mCRPC), a cancer that has spread to different parts of the body and did not respond to prior treatment(s). Lorigerlimab is a type of drug called a DART® molecule. The immune system makes proteins called antibodies that fight infection or kill abnormal cells by attaching to the cell and telling the body to kill them. Lorigerlimab attaches to two targets, PD-1 and CTLA-4. The combination of docetaxel and prednisone is an approved standard treatment regimen for mCRPC. This study is a randomised, open-label study of lorigerlimab given with docetaxel and prednisone versus SoC with docetaxel and prednisone to determine side effects of lorigerlimab plus docetaxel and prednisone; how long the study drug stays in the blood; and does the lorigerlimab plus docetaxel and prednisone work better than SoC alone. Lorigerlimab and docetaxel are given intravenously (IV) once every 3 weeks. Prednisone is to be taken twice daily by mouth. During the treatment period, study visits occur weekly for first 3 weeks, then every 3 weeks. Assessments at each visit include ECGs, physical exam, blood draws, and CT and/or MRI scans.
Lorigerlimab can be given for up to 2 years, docetaxel and prednisone are given for up to 7 months as long as the participant’s disease has not progressed, and treatment is tolerated. For participants receiving only docetaxel and prednisone, whose cancer gets worse, may have an option to receive lorigerlimab for up to approximately 2 years. For participants assigned to SoC arm docetaxel plus prednisone, will receive treatment for up to 7 months.
An end of treatment visit will occur within 30 days of the last dose followed by additional blood tests and scans every 12 weeks for up to 2 years until the participant's cancer worsens or they start another treatment.REC name
Wales REC 3
REC reference
23/WA/0208
Date of REC Opinion
20 Sep 2023
REC opinion
Further Information Favourable Opinion