Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Immunotherapy and Prostate Cancer Recurrent, sponsored by MacroGenics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The rPFS is defined as the time from the date of randomization to the date of first documented PD per Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first.
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 |
What the registry record for NCT05848011 still lists
NCT05848011 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 681-participant average among 7 other Immunotherapy trials with a reported enrollment target (77% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Immunotherapy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Genomic and Methylation Markers in SCLC and LCNEC for Chemo-Immunotherapy Resistance Prediction (STRATUS)
RECRUITING
-
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform
RECRUITING
-
A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.
RECRUITING
-
Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy
RECRUITING
-
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
RECRUITING · NA
-
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04300998 · 154 participants
Study of CAR-T Therapy in Older Patients
- NCT04597372 · 154 participants · Phase 2
Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
- NCT05294042 · 154 participants · NA
Patient Navigators for Children's Community Mental Health Services in High Poverty Urban Communities
- NCT05512390 · 154 participants · Phase 1
A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI