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NCT05848011 · ClinicalTrials.gov registry record · Phase 2
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study of Immunotherapy and Prostate Cancer Recurrent, sponsored by MacroGenics.
- Active
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT05848011 is a Phase 2 study of Immunotherapy and Prostate Cancer Recurrent that is active but no longer recruiting, run by MacroGenics. The registered enrollment target is 154 participants, below the 681-participant average among 7 other Immunotherapy trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT05848011, a Phase 2 study of Immunotherapy and Prostate Cancer Recurrent, is active but no longer recruiting, sponsored by MacroGenics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Prednisone
- DRUG docetaxel
- BIOLOGICAL lorigerlimab
Study Locations (20)
Other
- Concord Repatriation General Hospital - Concord
- Peter MacCallum Cancer Centre - North Melbourne
- North Shore Private Hospital - St Leonards
- Westmead Hospital - Westmead
- Cliniques universitaires Saint-Luc (CUSL), Brussels - Brussels
- UZ GENT - Ghent
- Centre Hospital de l'Ardenne - Libramont
- CHU de Liège - Liège
- MHAT Dr. Tota Venkova - Gabrovo
- Comprehensive Cancer Center - Plovdiv
Florida
- United Medical Group - Miami
- Orlando Health Cancer Institute - Orlando
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
New York
- Icahn School of Medicine at Mount Sinai - New York
- SUNY Upstate Medical University - Syracuse
Nebraska
- Nebraska Cancer Specialists - Grand Island
Texas
- MD Anderson Cancer Center - Houston
Utah
- START Mountain Region - West Valley City
Virginia
- University of Virginia Health System Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2023-09-28 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05848011
The ClinicalTrials.gov registry entry for NCT05848011 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 681-participant average among 7 other Immunotherapy trials with a reported enrollment target (77% lower). The listed sponsor is MacroGenics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Immunotherapy appearing as the primary indexed condition, and to 3 interventions - of which Prednisone is the first listed.
NCT05848011 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05848011 about?
NCT05848011 is a clinical study titled "A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer". 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 part...
What is the current status of trial NCT05848011?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2023-09-28. Estimated completion is 2026-03.
What conditions does trial NCT05848011 study?
This clinical trial studies the following conditions: Immunotherapy, Prostate Cancer Recurrent, Androgen-Independent Prostatic Cancer, Androgen-Independent Prostatic Neoplasms, Androgen-Insensitive Prostatic Cance.
What interventions are being tested in trial NCT05848011?
The interventions under investigation include: Prednisone (DRUG), docetaxel (DRUG), lorigerlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05848011?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05848011 being conducted?
This trial has 20 study locations across Florida, Massachusetts, Nebraska, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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