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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05848011
Registration number
NCT05848011
Ethics application status
Date submitted
17/04/2023
Date registered
8/05/2023
Titles & IDs
Public title
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
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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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Secondary ID [1]
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CP-MGD019-02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - lorigerlimab
Treatment: Drugs - docetaxel
Treatment: Drugs - Prednisone
Experimental: Lorigerlimab + Docetaxel and Prednisone - 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).
Other: Standard of care docetaxel and prednisone - Docetaxel 75 mg/m\^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months)
Treatment: Other: lorigerlimab
Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4
Treatment: Drugs: docetaxel
Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer
Treatment: Drugs: Prednisone
A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Median radiographic progression free survival (rPFS) determined by investigator review.
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Assessment method [1]
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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.
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Timepoint [1]
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Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
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Secondary outcome [1]
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Objective response rate (ORR) per PCWG3 criteria
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Assessment method [1]
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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
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Timepoint [1]
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Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
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Secondary outcome [2]
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Duration of response (DoR)
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Assessment method [2]
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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.
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Timepoint [2]
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Every 9 weeks for the first year, then every 12 weeks for up to 4 years
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Secondary outcome [3]
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Time to response (TTR)
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Assessment method [3]
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TTR is defined as the time from the start of treatment to the first objective response (CR or PR).
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Timepoint [3]
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Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
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Secondary outcome [4]
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PSA50 response rate
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Assessment method [4]
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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%.
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Timepoint [4]
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Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
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Secondary outcome [5]
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PSA90 response rate
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Assessment method [5]
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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%.
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Timepoint [5]
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Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
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Secondary outcome [6]
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Time to PSA progression
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Assessment method [6]
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Time to PSA progression is defined as the time from the date of randomization to the first documented PSA progression.
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Timepoint [6]
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Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years
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Secondary outcome [7]
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Duration of PSA response
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Assessment method [7]
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Duration of PSA response is defined as the time from the date of first PSA response to the earliest date of PSA progression.
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Timepoint [7]
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Every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.
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Secondary outcome [8]
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Overall survival (OS)
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Assessment method [8]
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OS is defined as the time from the date of randomization to the date of death from any cause.
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Timepoint [8]
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Throughout the study up to 4 years
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Secondary outcome [9]
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Time to First Symptomatic Skeletal Event (SSE)
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Assessment method [9]
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Time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE from any cause.
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Timepoint [9]
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Throughout the study up to 4 years
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Secondary outcome [10]
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Time to pain progression using the BPI-sf questionnaire
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Assessment method [10]
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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.
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Timepoint [10]
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Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years
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Secondary outcome [11]
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Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire
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Assessment method [11]
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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.
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Timepoint [11]
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Every 3 weeks up to 2 years
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Secondary outcome [12]
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Pain interference using the BPI-sf questionnaire
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Assessment method [12]
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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.
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Timepoint [12]
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Every 3 weeks up to 2 years
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Secondary outcome [13]
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Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire
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Assessment method [13]
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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.
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Timepoint [13]
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Every 3 weeks up to 2 years
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Secondary outcome [14]
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Description of types of adverse events (AEs) between treatment groups.
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Assessment method [14]
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Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation
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Timepoint [14]
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Throughout treatment up to 27 months
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Secondary outcome [15]
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Lorigerlimab maximum concentration or concentration at the end of infusion (Cmax)
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Assessment method [15]
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The highest measured concentration of lorigerlimab in the bloodstream.
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Timepoint [15]
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Every 21-day cycle throughout the study, for an average of 1 year.
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Secondary outcome [16]
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Lorigerlimab area under the concentration time curve (AUC)
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Assessment method [16]
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AUC is the total amount of lorigerlimab in bloodstream after drug administration
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Timepoint [16]
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Every 21-day cycle throughout the study, for an average of 1 year.
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Secondary outcome [17]
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Trough drug concentration (Ctrough or Cmin)
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Assessment method [17]
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Trough concentration is the concentration measured before a subsequent dose of lorigerlimab
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Timepoint [17]
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Every 21-day cycle throughout the study, for an average of 1 year.
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Secondary outcome [18]
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Clearance (CL)
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Assessment method [18]
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Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time
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Timepoint [18]
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Every 21-day cycle throughout the study, for an average of 1 year.
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Secondary outcome [19]
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Volume of distribution (Vz)
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Assessment method [19]
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The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream.
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Timepoint [19]
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Every 21-day cycle throughout the study, for an average of 1 year.
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Secondary outcome [20]
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Terminal half-life
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Assessment method [20]
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Terminal elimination half-life is the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%
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Timepoint [20]
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Every 21-day cycle throughout the study, for an average of 1 year.
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Secondary outcome [21]
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Number of participants who develop anti-drug antibodies
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Assessment method [21]
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Timepoint [21]
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Throughout the study, up to 2 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2027
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - North Melbourne
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Recruitment hospital [2]
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North Shore Private Hospital - St Leonards
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Recruitment hospital [3]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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- North Melbourne
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Recruitment postcode(s) [2]
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- St Leonards
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Recruitment postcode(s) [3]
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- Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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United States of America
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State/province [2]
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Massachusetts
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United States of America
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State/province [3]
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Nebraska
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United States of America
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State/province [4]
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Texas
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Country [5]
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United States of America
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State/province [5]
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Utah
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Country [6]
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United States of America
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State/province [6]
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Virginia
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Country [7]
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Belgium
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State/province [7]
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Brussel
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Country [8]
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Belgium
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State/province [8]
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Gent
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Country [9]
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Belgium
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State/province [9]
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Libramont
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Country [10]
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Belgium
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State/province [10]
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Liège
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Country [11]
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Bulgaria
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State/province [11]
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Gabrovo
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Country [12]
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Bulgaria
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State/province [12]
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Plovdiv
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Bulgaria
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State/province [13]
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Sofia
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Country [14]
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France
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State/province [14]
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Bordeaux
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Country [15]
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France
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State/province [15]
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Le Mans
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Country [16]
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France
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State/province [16]
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Lyon
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Country [17]
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France
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State/province [17]
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Nice
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Country [18]
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France
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State/province [18]
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Paris
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Country [19]
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France
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State/province [19]
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Quimper
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Country [20]
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France
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State/province [20]
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Saint-Grégoire
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Country [21]
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France
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State/province [21]
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Saint-Mandé
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France
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State/province [22]
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Suresnes
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France
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State/province [23]
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Villejuif
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Country [24]
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Georgia
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State/province [24]
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Batumi
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Georgia
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Tbilisi
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Poland
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Konin
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Poland
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State/province [27]
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Kraków
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Country [28]
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Poland
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State/province [28]
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Otwock
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Country [29]
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Poland
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State/province [29]
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Warsaw
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Country [30]
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Puerto Rico
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State/province [30]
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Rio Piedras
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Spain
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State/province [31]
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Barcelona
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Country [32]
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Spain
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State/province [32]
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Madrid
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Country [33]
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Spain
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State/province [33]
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Sevilla
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Country [34]
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Spain
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State/province [34]
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Valencia
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Country [35]
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United Kingdom
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State/province [35]
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Headington
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Country [36]
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United Kingdom
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State/province [36]
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London
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Country [37]
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United Kingdom
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State/province [37]
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Sutton
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Country [38]
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United Kingdom
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State/province [38]
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Taunton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
MacroGenics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05848011
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Denise Casey, M.D.
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Address
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MacroGenics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Global Trial Manager
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Address
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Country
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Phone
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301-251-5172
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05848011