Trials / Completed
CompletedNCT05848011
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | lorigerlimab | Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4 |
| DRUG | docetaxel | Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer |
| DRUG | Prednisone | A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer |
Timeline
- Start date
- 2023-09-28
- Primary completion
- 2026-02-19
- Completion
- 2026-03-16
- First posted
- 2023-05-08
- Last updated
- 2026-04-17
Locations
61 sites across 10 countries: United States, Australia, Belgium, Bulgaria, France, Georgia, Poland, Puerto Rico, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05848011. Inclusion in this directory is not an endorsement.