Study on Lorigerlimab with Docetaxel or Docetaxel Alone for Advanced Prostate Cancer

Sponsor: MacroGenics

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05848011

Provider View

This clinical trial is testing whether adding the drug lorigerlimab to the standard treatment of docetaxel and prednisone can help delay the progression of advanced prostate cancer that no longer responds to hormone therapy.

Patient Parameters

Program Overview

The study aims to find out if combining lorigerlimab with the usual treatment of docetaxel and prednisone can extend the time before the cancer worsens in men with advanced prostate cancer that has spread and is resistant to hormone therapy. About 150 participants will be involved, with two-thirds receiving lorigerlimab along with docetaxel and prednisone, and the rest receiving only docetaxel and prednisone. Treatments will be given in cycles, with lorigerlimab administered for up to 35 cycles and docetaxel and prednisone for up to 10 cycles. Participants will have regular scans and blood tests to monitor their cancer, and they will complete health questionnaires. If the cancer progresses in those receiving only the standard treatment, they may switch to lorigerlimab alone.

Eligibility Criteria

Inclusion Criteria

  • Have advanced prostate cancer that has spread and does not respond to hormone therapy.
  • Have at least one area of cancer that can be measured or tracked.
  • Show signs of cancer progression despite previous hormone therapy.
  • Have tried at least one other hormone therapy before.
  • If you have a BRCA gene mutation, you must have tried a PARP inhibitor treatment.
  • Be in good enough health to participate, with a reasonable life expectancy and normal lab results.

Exclusion Criteria

  • Have any condition that makes it difficult to receive or tolerate the study treatments.
  • Have had chemotherapy for advanced prostate cancer or certain immune therapies before.
  • Have active or ongoing infections.
  • Have significant heart, lung, or digestive system issues.
  • Be allergic to any of the study drugs or their components.

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