Study of Lorigerlimab and Docetaxel for Patients with Metastatic Castration-Resistant Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as Metastatic Castration-Resistant Prostate Cancer. This is a form of prostate cancer that continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study is investigating the effects of a new treatment combination involving a medication called Lorigerlimab and another drug named Docetaxel, compared to using Docetaxel alone. Lorigerlimab is a type of protein designed to help the immune system fight cancer by targeting specific proteins on cancer cells.

The purpose of the study is to evaluate how effective the combination of Lorigerlimab and Docetaxel is in treating this type of prostate cancer. Participants in the study will be randomly assigned to receive either the combination of Lorigerlimab and Docetaxel or Docetaxel alone. The study will monitor the participants over a period to see how the cancer responds to the treatment. This includes checking if the cancer stops growing or shrinks, and how long it takes for the cancer to start growing again. The study will also look at the overall health and survival of the participants, as well as any side effects they may experience.

Throughout the study, participants will receive regular check-ups and tests to monitor their health and the progress of the cancer. These tests may include imaging scans and blood tests to measure the levels of prostate-specific antigen (PSA), a substance often found in higher amounts in men with prostate cancer. The study aims to provide valuable information on whether the new treatment combination can offer better outcomes for patients with Metastatic Castration-Resistant Prostate Cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to prostate cancer progression and previous treatments.

Participants must have a type of prostate cancer that has spread and is resistant to standard hormone therapy.

2 treatment assignment

Participants are randomly assigned to receive either a combination of lorigerlimab and docetaxel or docetaxel alone.

The purpose is to compare the effectiveness of the combination treatment against the standard treatment.

3 medication administration

Docetaxel is administered as a solution for infusion, which means it is given through a vein.

Lorigerlimab is also administered intravenously, as a concentrate for solution for infusion.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment, including imaging tests to evaluate cancer progression.

Blood tests and other assessments are performed to monitor health and any side effects.

5 completion of treatment

The study continues until the estimated end date in September 2027, or until specific criteria for stopping treatment are met.

Participants are followed up to evaluate long-term outcomes and any lasting effects of the treatment.

Who Can Join the Study?

  • The patient must have metastatic castration-resistant adenocarcinoma of the prostate. This means the prostate cancer has spread to other parts of the body and is not responding to treatments that lower testosterone.
  • The cancer should not show signs of neuroendocrine differentiation, signet cell, or small cell features. These are specific types of cancer cell changes that are not allowed in this study.
  • The patient must have at least one metastatic lesion. This means there is at least one area where the cancer has spread, which can be measured or identified by doctors.
  • The patient must show prostate cancer progression at the start of the study. This means the cancer is getting worse according to specific criteria used by doctors.
  • The patient must have evidence of the disease getting worse after trying at least one previous treatment that targets the androgen receptor axis. This includes medications like abiraterone, enzalutamide, apalutamide, or darolutamide.
  • If the patient has a known history of a BRCA gene mutation, they must have already received a treatment called a PARP inhibitor.
  • The patient must have an adequate performance status, which means they are well enough to participate in the study, along with a reasonable life expectancy and acceptable laboratory values. These are basic health checks to ensure the patient can safely take part in the trial.
  • Only male patients are eligible to participate in this study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Metastatic Castration-Resistant Prostate Cancer. This is a specific type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Patients who are female. This study is only for male patients.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, like those who cannot make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Medical Concierge Centrum Medyczne Warsaw Poland

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland

Other Sites

Site Name City Country Status
Lux Med Onkologia Sp. z o.o. Warsaw Poland
Centre Antoine Lacassagne Nice France
Hospital Foch Suresnes France
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Virgen del Rocío University Hospital Sevilla Spain
Unite De Recherche Clinique HIA Begin Saint-Mande France
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Pratia S.A. Skorzewo Poland
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre hospitalier universitaire de Liege Liege Belgium
Clinique Victor Hugo Le Mans France
VIVALIA – Centre Hospitalier de l’Ardenne Libramont-Chevigny Belgium
Ccznbnmcz Uhfgzjlrlnpsvq Shwqmowoe Woluwe-Saint-Lambert Belgium
Hdgbeqwy Dk Lo Sfjdo Cpsr I Shcu Prr Barcelona Spain
Cncupr Lsmq Bidnnh Lyon France
Izvvixtn Cxwvev Dtmlgcrohhdhkqyzu L'hospitalet De Llobregat Spain
Idqemwvl Mrsswtpwhr Mwhtcpitlv Paris France
Hzeptmaf Uaheqzlrykwxp Hjwgaaxz Tkxya y Psgqhp Ismxnmeh Chnclt dsofgxmnduyimgqce (sdci Badalona Spain
Prdsdpxeaor Lazgtnia &nwfoqnfdfhsqqrnutqr Rejib Kzxcdxzqgey Konin Poland
Hpvhdzjz Vude djijtyke Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.09.2023
Bulgaria Bulgaria
Not recruiting
15.09.2023
France France
Not recruiting
15.09.2023
Poland Poland
Not recruiting
15.09.2023
Spain Spain
Not recruiting
15.09.2023

Trial locations

Lorigerlimab is an investigational medication being studied for its potential to treat metastatic castration-resistant prostate cancer. It is being tested in combination with another medication to see if it can improve outcomes for patients with this type of cancer.

Docetaxel is a chemotherapy drug commonly used to treat various types of cancer, including prostate cancer. In this study, it is used both alone and in combination with lorigerlimab to determine its effectiveness in treating metastatic castration-resistant prostate cancer.

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. It is characterized by cancer cells that have adapted to survive in a low-testosterone environment, making them resistant to traditional hormone therapy. The disease often progresses by spreading to bones and other organs, leading to various symptoms such as pain and difficulty with urination. Over time, the cancer may cause significant discomfort and impact daily activities. The progression of this disease is typically monitored through imaging tests and blood markers.

Trial ID:
2022-502982-49-00
Protocol code:
CP-MGD019-02
NCT ID:
NCT05848011
Trial Phase:
Therapeutic exploratory (Phase II)

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