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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
Scientific title
A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
CP-MGD019-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgen-Independent Prostatic Cancer 0 0
Androgen-Independent Prostatic Neoplasms 0 0
Prostate Cancer Recurrent 0 0
Androgen-Insensitive Prostatic Cance 0 0
Androgen-Resistant Prostatic Cancer 0 0
Hormone Refractory Prostatic Cancer 0 0
Immunotherapy 0 0
Immune Checkpoint Inhibitor 0 0
Inhibitory Checkpoint Molecule 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Median radiographic progression free survival (rPFS) determined by investigator review.
Timepoint [1] 0 0
Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
Secondary outcome [1] 0 0
Objective response rate (ORR) per PCWG3 criteria
Timepoint [1] 0 0
Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
Secondary outcome [2] 0 0
Duration of response (DoR)
Timepoint [2] 0 0
Every 9 weeks for the first year, then every 12 weeks for up to 4 years
Secondary outcome [3] 0 0
Time to response (TTR)
Timepoint [3] 0 0
Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
Secondary outcome [4] 0 0
PSA50 response rate
Timepoint [4] 0 0
Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
Secondary outcome [5] 0 0
PSA90 response rate
Timepoint [5] 0 0
Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
Secondary outcome [6] 0 0
Time to PSA progression
Timepoint [6] 0 0
Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years
Secondary outcome [7] 0 0
Duration of PSA response
Timepoint [7] 0 0
Every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.
Secondary outcome [8] 0 0
Overall survival (OS)
Timepoint [8] 0 0
Throughout the study up to 4 years
Secondary outcome [9] 0 0
Time to First Symptomatic Skeletal Event (SSE)
Timepoint [9] 0 0
Throughout the study up to 4 years
Secondary outcome [10] 0 0
Time to pain progression using the BPI-sf questionnaire
Timepoint [10] 0 0
Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years
Secondary outcome [11] 0 0
Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire
Timepoint [11] 0 0
Every 3 weeks up to 2 years
Secondary outcome [12] 0 0
Pain interference using the BPI-sf questionnaire
Timepoint [12] 0 0
Every 3 weeks up to 2 years
Secondary outcome [13] 0 0
Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire
Timepoint [13] 0 0
Every 3 weeks up to 2 years
Secondary outcome [14] 0 0
Description of types of adverse events (AEs) between treatment groups.
Timepoint [14] 0 0
Throughout treatment up to 27 months
Secondary outcome [15] 0 0
Lorigerlimab maximum concentration or concentration at the end of infusion (Cmax)
Timepoint [15] 0 0
Every 21-day cycle throughout the study, for an average of 1 year.
Secondary outcome [16] 0 0
Lorigerlimab area under the concentration time curve (AUC)
Timepoint [16] 0 0
Every 21-day cycle throughout the study, for an average of 1 year.
Secondary outcome [17] 0 0
Trough drug concentration (Ctrough or Cmin)
Timepoint [17] 0 0
Every 21-day cycle throughout the study, for an average of 1 year.
Secondary outcome [18] 0 0
Clearance (CL)
Timepoint [18] 0 0
Every 21-day cycle throughout the study, for an average of 1 year.
Secondary outcome [19] 0 0
Volume of distribution (Vz)
Timepoint [19] 0 0
Every 21-day cycle throughout the study, for an average of 1 year.
Secondary outcome [20] 0 0
Terminal half-life
Timepoint [20] 0 0
Every 21-day cycle throughout the study, for an average of 1 year.
Secondary outcome [21] 0 0
Number of participants who develop anti-drug antibodies
Timepoint [21] 0 0
Throughout the study, up to 2 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - North Melbourne
Recruitment hospital [3] 0 0
North Shore Private Hospital - St Leonards
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- North Melbourne
Recruitment postcode(s) [3] 0 0
- St Leonards
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussel
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Belgium
State/province [10] 0 0
Libramont
Country [11] 0 0
Belgium
State/province [11] 0 0
Liège
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Gabrovo
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Plovdiv
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sofia
Country [15] 0 0
France
State/province [15] 0 0
Bordeaux
Country [16] 0 0
France
State/province [16] 0 0
Le Mans
Country [17] 0 0
France
State/province [17] 0 0
Lyon
Country [18] 0 0
France
State/province [18] 0 0
Nice
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Quimper
Country [21] 0 0
France
State/province [21] 0 0
Saint-Grégoire
Country [22] 0 0
France
State/province [22] 0 0
Saint-Mandé
Country [23] 0 0
France
State/province [23] 0 0
Suresnes
Country [24] 0 0
France
State/province [24] 0 0
Villejuif
Country [25] 0 0
Georgia
State/province [25] 0 0
Batumi
Country [26] 0 0
Georgia
State/province [26] 0 0
Tbilisi
Country [27] 0 0
Poland
State/province [27] 0 0
Konin
Country [28] 0 0
Poland
State/province [28] 0 0
Kraków
Country [29] 0 0
Poland
State/province [29] 0 0
Otwock
Country [30] 0 0
Poland
State/province [30] 0 0
Warsaw
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
Rio Piedras
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Sevilla
Country [35] 0 0
Spain
State/province [35] 0 0
Valencia
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Headington
Country [37] 0 0
United Kingdom
State/province [37] 0 0
London
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Sutton
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MacroGenics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Denise Casey, M.D.
Address 0 0
MacroGenics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Global Trial Manager
Address 0 0
Country 0 0
Phone 0 0
301-251-5172
Fax 0 0
Email 0 0
info@macrogenics.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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