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No longer recruiting (closed or complete)Last updated: 7 March 2025

This study aims to establish if adding immunotherapy to the standard treatment of chemotherapy and prednisone can delay disease progression in people with metastatic castration-resistant prostate cancer (mCRPC).A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Clinical summary

Summary

Approximately 150 participants with metastatic castration-resistant prostate cancer will be randomally allocated into to one of two treatment arms.

Experimental Arm: Participants will receive immunotherapy (lorigerlimab) with standard treatment (docetaxel and oral prednisone). Lorigerlimab + docetaxel will be administered through IV injections in a clinic on Day 1 of a 3-week cycle. Lorigerlimab will be administered for up to 35 cycles. 

Comparator Arm: Participants will recieve standard care of chemotherapy (docetaxel) and prednisone. Docetaxel will be administered for up to 10 cycles until treatment discontinuation criteria are met. Prednisone will be administered orally twice a day.

Participants will undergo regular tests such as CT scans, MRI, and PSA blood tests to monitor disease progression.

Participants will also complete questionnaires about their health and wellbeing, with routine examinations and blood tests performed by the study doctor. 

If participants in the Comparator Arm experience disease progression whilst in the study they can choose to receive lorigerlimab without other treatment.

Conditions

This trial is treating people with metastatic castration-resistant prostate cancer

Eligibility

Inclusion

  • Metastatic castration-resistant adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
  • Participants must have ≥ 1 metastatic (measurable or non-measurable per PCWG3) lesion.
  • Participant has prostate cancer progression at study entry based on PCWG3 criteria.
  • Participant shows evidence of disease progression after receiving at least 1 prior androgen receptor axis-targeted therapy (ARAT) regimen (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide).
  • Patients with known history of documented breast cancer gene (BRCA) mutation (germline or somatic) must have received an approved poly ADP ribose polymerase (PARP) inhibitor regimen.
  • Participants must have adequate performance status, life expectancy and laboratory values.

Exclusion

  • Any condition preventing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
  • Received prior chemotherapy for mCRPC or checkpoint inhibitors for prostate cancer.
  • Current active or chronic infections.
  • Any clinically significant heart, lung, or gastrointestinal disorders.
  • Allergy to any of the study treatments or components of the study treatments.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

MacroGenics

Scientific Title

A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

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