Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Docetaxel

Prednisone

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Lorigerlimab 6 mg/kg IV (up to 2 years) and docetaxel 75 mg/m\^2 IV every 3 weeks (up to 7 months) and prednisone 5 mg orally twice daily (up to 7 months).

Docetaxel 75 mg/m\^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months)

Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4

lorigerlimab

Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer

docetaxel

A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer

Global Trial Manager

Alvaro Ocampo

Hatem Hassanein

Daniel Fein

Xiao Wei

Ralph Hauke, MD, FACP

Sumit Subudhi

Joseph Call, MD

William Skelton

Shahneen Sandhu

Jean Pascal Machiels

Sylvie Rottey

Frédéric Forget

Brieuc Sautois

Bonka Popova

Antoaneta Tomova

Bozhil Robev

Guilhem Roubaud

Eric Voog

Delphine Borchiellini

Mostefa Bennamoun

Friederike Schlurmann

Xavier Artignan

Carole Helissey

Raffaele Ratta

Alice Bernard Tessier

Tamta Makharadze

David Kochiashvili

Giorgi Adeishvili

Archil Chkhotua

Guram Karazanashvili

Tamar Melkadze

Amiran Matitashvili

Bogusława Karaszewska

Bożena Cybulska-Stopa

Cezary Szczylik

Jakub Żołnierek

Piotr Radziszewski

Iwona Skoneczna

Josselyn Molina-Avila

Begoña Mellado

Alejo Rodríguez-Vida

Enrique Gallardo

Jose Maroto

Elena Castro

Santiago Cabezas-Camarero

Begona Pérez Valderrama

Maria Jose Juan Fita

Mark Tuthill

Naveed Sarwar

Johann de Bono

Emma Gray

Denise Casey, M.D.

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.

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

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

The rPFS is defined as the time from the date of randomization to the date of first documented PD per Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first.

ORR is defined as the number of participants who have a best overall response of confirmed complete response (CR) or partial response (PR) without prior confirmed bone progression

DoR is the time from the date of initial tumor response (CR or PR) to the date of first disease progression or death from any cause, whichever occurs first.

TTR is defined as the time from the start of treatment to the first objective response (CR or PR).

PSA50 response is defined as a ≥ 50% decline in PSA from baseline with confirmation at least 3 weeks after the first documented reduction in PSA of ≥ 50%.

PSA90 response is defined as a ≥ 90% decline in PSA from baseline with confirmation at least 3 weeks after the first documented reduction in PSA of ≥ 90%.

Time to PSA progression is defined as the time from the date of randomization to the first documented PSA progression.

Duration of PSA response is defined as the time from the date of first PSA response to the earliest date of PSA progression.

OS is defined as the time from the date of randomization to the date of death from any cause.

Time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE from any cause.

Time to pain progression is defined as the time interval from randomization to the first date a participant experiences pain progression. Higher scores indicate more severe pain.

The BPI-sf pain severity score consists of 4 items that assess pain at its worst, least, average, and current pain intensity. The pain severity score is the average of the 4 item scores. Higher scores indicate more severe pain.

The BPI-sf pain interference score includes 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The pain interference score is the average of the 7 interference items. Higher scores indicate more interference from pain in daily life.

The FACT-P consists of 27 items from the Functional Assessment of Cancer Therapy-General (FACT-G) that measure physical, social/family, emotional, and functional well-being and 12 items that compose the Prostate Cancer Subscale (PCS). Higher scores indicate greater impact of prostate cancer on daily life.

Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation

The highest measured concentration of lorigerlimab in the bloodstream.

AUC is the total amount of lorigerlimab in bloodstream after drug administration

Trough concentration is the concentration measured before a subsequent dose of lorigerlimab

Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time

The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream.

Terminal elimination half-life is the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%

Spots Global Cancer Trial Database for lorigerlimab

Every month we try and update this database with for lorigerlimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.