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New drug combo aims to slow advanced prostate cancer

NCT ID NCT05848011

Disease control Sponsor: MacroGenics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding an immunotherapy drug called lorigerlimab to standard chemotherapy (docetaxel) can help men with a tough-to-treat type of prostate cancer live longer without their disease getting worse. About 150 men with metastatic castration-resistant prostate cancer will be randomly assigned to get either the combo or chemo alone. The main goal is to see if the combo delays cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lorigerlimab (an immunotherapy drug that targets PD-1 and CTLA-4) combined with docetaxel (chemotherapy) and prednisone (steroid)
What this could lead to
If successful, this combination could offer a new treatment option that delays disease progression in men with advanced prostate cancer that no longer responds to hormone therapy.
What could go wrong
This is a Phase 2 trial with only 154 participants, so results may not apply to all patients. Adding immunotherapy to chemotherapy can increase side effects like immune-related inflammation, and the benefit may be modest or not confirmed in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

154 people

The number who actually took part.

Started

Sep 2023

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma hormone-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer prostate carcinoma Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Androgen-independent prostatic cancer Androgen-independent prostatic neoplasms Androgen-insensitive prostatic cance Androgen-resistant prostatic cancer Hormone refractory prostatic cancer Immune checkpoint inhibitor Immunotherapy Inhibitory checkpoint molecule Prostate cancer recurrent

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHP Saint Grégoire

    Saint-Grégoire, France

  • CHU de Liège

    Liège, Belgium

  • Centre Antoine Lacassagne

    Nice, France

  • Centre Hospital de l'Ardenne

    Libramont, Belgium

  • Centre Hospitalier Quimper

    Quimper, France

  • Centre Léon Bérard

    Lyon, France

  • Charing Cross Hospital

    London, United Kingdom

  • Churchill Hospital

    Headington, United Kingdom

  • Clinique Victor Hugo

    Le Mans, France

  • Cliniques universitaires Saint-Luc (CUSL), Brussels

    Brussels, Belgium

  • Comprehensive Cancer Center

    Plovdiv, Bulgaria

  • Concord Repatriation General Hospital

    Concord, Australia

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina

    Otwock, Poland

  • FIVO: Instituto Valenciano de Oncología

    Valencia, Spain

  • First University Clinic TSMU

    Tbilisi, Georgia

  • H U Germans Tries i Pujol

    Barcelona, Spain

  • Hia Begin

    Saint-Mandé, France

  • Hopital Foch

    Suresnes, France

  • Hospital 12 de octubre

    Madrid, Spain

  • Hospital Clínic de Barcelona

    Barcelona, Spain

  • Hospital Parc Tauli

    Barcelona, Spain

  • Hospital Sant Pau

    Barcelona, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institut Bergonie

    Bordeaux, France

  • Institut Català d'Oncologia Hospitalet_ICO Hospitalet

    Barcelona, Spain

  • Institut Gustave Roussy

    Villejuif, France

  • Institut Mutualiste Montsouris

    Paris, France

  • LTD Consilium Medulla

    Tbilisi, Georgia

  • LTD High Tech Hosp Medcenter

    Batumi, Georgia

  • LTD MMT Hospital

    Tbilisi, Georgia

  • LTD Todua Clinic

    Tbilisi, Georgia

  • LtD L.M.National Urology Center

    Tbilisi, Georgia

  • Ltd Gidmedi

    Tbilisi, Georgia

  • LuxMed Onkologia

    Warsaw, Poland

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MHAT Dr. Tota Venkova

    Gabrovo, Bulgaria

  • Medical Concierge

    Warsaw, Poland

  • Musgrove Park Hospital

    Taunton, United Kingdom

  • Nebraska Cancer Specialists

    Grand Island, Nebraska, 68803, United States

  • North Shore Private Hospital

    St Leonards, Australia

  • Onc. Scient. Research Center

    Tbilisi, Georgia

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, Puerto Rico

  • Peter MacCallum Cancer Centre

    North Melbourne, Australia

  • Pratia McM Kraków

    Krakow, Poland

  • Przychodnia Lekarska KOMED

    Konin, Poland

  • Royal Marsden Hospital

    Sutton, United Kingdom

  • START Mountain Region

    West Valley City, Utah, 84119, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., Oddział Chemioterapii

    Warsaw, Poland

  • Szpital Woj. im M Kopernika

    Koszalin, Poland

  • UMHAT Sv. Ivan Rilski

    Sofia, Bulgaria

  • UZ GENT

    Ghent, Belgium

  • United Medical Group

    Miami, Florida, 33135, United States

  • University of Virginia Health System Cancer Center

    Charlottesville, Virginia, 22903, United States

  • Vall d' Hebron Institute of Oncology (VHIO)

    Barcelona, Spain

  • Westmead Hospital

    Westmead, Australia

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Other studies related to the condition(s) this trial covers.