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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05848011




Registration number
NCT05848011
Ethics application status
Date submitted
17/04/2023
Date registered
8/05/2023
Date last updated
16/04/2024

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
Other interventions - 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)


Other interventions: 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
Other interventions
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
Peter MacCallum Cancer Centre - North Melbourne
Recruitment postcode(s) [1] 0 0
- North Melbourne
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
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussel
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Libramont
Country [10] 0 0
Belgium
State/province [10] 0 0
Liège
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Gabrovo
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Plovdiv
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Sofia
Country [14] 0 0
France
State/province [14] 0 0
Bordeaux
Country [15] 0 0
France
State/province [15] 0 0
Le Mans
Country [16] 0 0
France
State/province [16] 0 0
Nice
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Quimper
Country [19] 0 0
France
State/province [19] 0 0
Saint-Grégoire
Country [20] 0 0
France
State/province [20] 0 0
Saint-Mandé
Country [21] 0 0
France
State/province [21] 0 0
Suresnes
Country [22] 0 0
France
State/province [22] 0 0
Villejuif
Country [23] 0 0
Georgia
State/province [23] 0 0
Batumi
Country [24] 0 0
Georgia
State/province [24] 0 0
Tbilisi
Country [25] 0 0
Poland
State/province [25] 0 0
Konin
Country [26] 0 0
Poland
State/province [26] 0 0
Kraków
Country [27] 0 0
Poland
State/province [27] 0 0
Otwock
Country [28] 0 0
Poland
State/province [28] 0 0
Warsaw
Country [29] 0 0
Puerto Rico
State/province [29] 0 0
Rio Piedras
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Sevilla
Country [33] 0 0
Spain
State/province [33] 0 0
Valencia
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Headington
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Sutton
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Taunton

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05848011
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05848011