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A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT05848011 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-05-22

No results posted yet for this 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

  • 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

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

Sponsors & Collaborators

Principal Investigators

  • Pepi Pencheva, M.D. · MacroGenics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2026-02-19
Completion
2026-03-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • France
  • Georgia
  • Poland
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05848011 on ClinicalTrials.gov