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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05848011
Other study ID # CP-MGD019-02
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 28, 2023
Est. completion date September 2027

Study information

Verified date April 2024
Source MacroGenics
Contact Global Trial Manager
Phone 301-251-5172
Email info@macrogenics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 2027
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
lorigerlimab
Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4
Drug:
docetaxel
Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer
Prednisone
A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer

Locations

Country Name City State
Australia Peter MacCallum Cancer Centre North Melbourne
Belgium Cliniques universitaires Saint-Luc (CUSL), Brussels Brussel
Belgium UZ GENT Gent
Belgium Centre Hospital de l'Ardenne Libramont
Belgium CHU de Liège Liège
Bulgaria MHAT Dr. Tota Venkova Gabrovo
Bulgaria Comprehensive Cancer Center Plovdiv
Bulgaria UMHAT Sv. Ivan Rilski Sofia
France Institut Bergonie Bordeaux
France Clinique Victor Hugo Le Mans
France Centre Antoine Lacassagne Nice
France Institut Mutualiste Montsouris Paris
France Centre Hospitalier Quimper Quimper
France CHP Saint Grégoire Saint-Grégoire
France Hia Begin Saint-Mandé
France Hopital Foch Suresnes
France Institut Gustave Roussy Villejuif
Georgia LTD High Tech Hosp Medcenter Batumi
Georgia First University Clinic TSMU Tbilisi
Georgia LTD Consilium Medulla Tbilisi
Georgia LtD L.M.National Urology Center Tbilisi
Georgia LTD MMT Hospital Tbilisi
Georgia LTD Todua Clinic Tbilisi
Georgia Onc. Scient. Research Center Tbilisi
Poland Przychodnia Lekarska KOMED Konin
Poland Pratia McM Kraków Kraków
Poland Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina Otwock
Poland LuxMed Onkologia Warsaw
Poland Medical Concierge Warsaw
Poland Szpital Grochowski im. dr med. Rafala Masztaka Sp. z o.o., Oddzial Chemioterapii Warsaw
Puerto Rico Pan American Center for Oncology Trials, LLC Rio Piedras
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Parc Tauli Barcelona
Spain Hospital Sant Pau Barcelona
Spain Hospital 12 de octubre Madrid
Spain Hospital Beata Maria Ana Madrid
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain FIVO: Instituto Valenciano de Oncología Valencia
United Kingdom Churchill Hospital Headington
United Kingdom Charing Cross Hospital London
United Kingdom Royal Marsden Hospital Sutton
United Kingdom Musgrove Park Hospital Taunton
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States University of Virginia Health System Cancer Center Charlottesville Virginia
United States Nebraska Cancer Specialists Grand Island Nebraska
United States MD Anderson Cancer Center Houston Texas
United States United Medical Group Miami Florida
United States Orlando Health Cancer Institute Orlando Florida
United States START Mountain Region West Valley City Utah

Sponsors (1)

Lead Sponsor Collaborator
MacroGenics

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  France,  Georgia,  Poland,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median radiographic progression free survival (rPFS) determined by investigator review. 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. Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
Secondary Objective response rate (ORR) per PCWG3 criteria 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 Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
Secondary Duration of response (DoR) 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. Every 9 weeks for the first year, then every 12 weeks for up to 4 years
Secondary Time to response (TTR) TTR is defined as the time from the start of treatment to the first objective response (CR or PR). Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
Secondary PSA50 response rate 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%. Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
Secondary PSA90 response rate 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%. Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
Secondary Time to PSA progression Time to PSA progression is defined as the time from the date of randomization to the first documented PSA progression. Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years
Secondary Duration of PSA response Duration of PSA response is defined as the time from the date of first PSA response to the earliest date of PSA progression. Every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.
Secondary Overall survival (OS) OS is defined as the time from the date of randomization to the date of death from any cause. Throughout the study up to 4 years
Secondary Time to First Symptomatic Skeletal Event (SSE) Time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE from any cause. Throughout the study up to 4 years
Secondary Time to pain progression using the BPI-sf questionnaire 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. Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years
Secondary Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire 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. Every 3 weeks up to 2 years
Secondary Pain interference using the BPI-sf questionnaire 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. Every 3 weeks up to 2 years
Secondary Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire 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. Every 3 weeks up to 2 years
Secondary Description of types of adverse events (AEs) between treatment groups. Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation Throughout treatment up to 27 months
Secondary Lorigerlimab maximum concentration or concentration at the end of infusion (Cmax) The highest measured concentration of lorigerlimab in the bloodstream. Every 21-day cycle throughout the study, for an average of 1 year.
Secondary Lorigerlimab area under the concentration time curve (AUC) AUC is the total amount of lorigerlimab in bloodstream after drug administration Every 21-day cycle throughout the study, for an average of 1 year.
Secondary Trough drug concentration (Ctrough or Cmin) Trough concentration is the concentration measured before a subsequent dose of lorigerlimab Every 21-day cycle throughout the study, for an average of 1 year.
Secondary Clearance (CL) Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time Every 21-day cycle throughout the study, for an average of 1 year.
Secondary Volume of distribution (Vz) The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream. Every 21-day cycle throughout the study, for an average of 1 year.
Secondary Terminal half-life Terminal elimination half-life is the time it takes for the concentration of the drug in plasma or serum to be reduced by 50% Every 21-day cycle throughout the study, for an average of 1 year.
Secondary Number of participants who develop anti-drug antibodies Throughout the study, up to 2 years
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