Trial record 1 of 1 for:
CP-MGD019-02
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05848011 |
|
Recruitment Status :
Recruiting
First Posted : May 8, 2023
Last Update Posted : April 16, 2024
|
Sponsor:
MacroGenics
Information provided by (Responsible Party):
MacroGenics
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Androgen-Independent Prostatic Cancer Androgen-Independent Prostatic Neoplasms Prostate Cancer Recurrent Androgen-Insensitive Prostatic Cance Androgen-Resistant Prostatic Cancer Hormone Refractory Prostatic Cancer Immunotherapy Immune Checkpoint Inhibitor Inhibitory Checkpoint Molecule | Biological: lorigerlimab Drug: docetaxel Drug: Prednisone | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer |
| Actual Study Start Date : | September 28, 2023 |
| Estimated Primary Completion Date : | September 2026 |
| Estimated Study Completion Date : | September 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
|
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).
|
Biological: lorigerlimab
Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4
Other Name: MGD019 Drug: docetaxel Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer
Other Name: Taxotere® Drug: Prednisone A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer |
|
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)
|
Drug: docetaxel
Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer
Other Name: Taxotere® Drug: Prednisone A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer |
Primary Outcome Measures :
- Median radiographic progression free survival (rPFS) determined by investigator review. [ Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years ]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.
Secondary Outcome Measures :
- Objective response rate (ORR) per PCWG3 criteria [ Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years ]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
- Duration of response (DoR) [ Time Frame: Every 9 weeks for the first year, then every 12 weeks for up to 4 years ]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.
- Time to response (TTR) [ Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years ]TTR is defined as the time from the start of treatment to the first objective response (CR or PR).
- PSA50 response rate [ Time Frame: Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years ]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 rate [ Time Frame: Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years ]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 [ Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years ]Time to PSA progression is defined as the time from the date of randomization to the first documented PSA progression.
- Duration of PSA response [ Time Frame: Every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years. ]Duration of PSA response is defined as the time from the date of first PSA response to the earliest date of PSA progression.
- Overall survival (OS) [ Time Frame: Throughout the study up to 4 years ]OS is defined as the time from the date of randomization to the date of death from any cause.
- Time to First Symptomatic Skeletal Event (SSE) [ Time Frame: Throughout the study up to 4 years ]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 using the BPI-sf questionnaire [ Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years ]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.
- Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire [ Time Frame: Every 3 weeks up to 2 years ]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.
- Pain interference using the BPI-sf questionnaire [ Time Frame: Every 3 weeks up to 2 years ]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.
- Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire [ Time Frame: Every 3 weeks up to 2 years ]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.
- Description of types of adverse events (AEs) between treatment groups. [ Time Frame: Throughout treatment up to 27 months ]Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation
- Lorigerlimab maximum concentration or concentration at the end of infusion (Cmax) [ Time Frame: Every 21-day cycle throughout the study, for an average of 1 year. ]The highest measured concentration of lorigerlimab in the bloodstream.
- Lorigerlimab area under the concentration time curve (AUC) [ Time Frame: Every 21-day cycle throughout the study, for an average of 1 year. ]AUC is the total amount of lorigerlimab in bloodstream after drug administration
- Trough drug concentration (Ctrough or Cmin) [ Time Frame: Every 21-day cycle throughout the study, for an average of 1 year. ]Trough concentration is the concentration measured before a subsequent dose of lorigerlimab
- Clearance (CL) [ Time Frame: Every 21-day cycle throughout the study, for an average of 1 year. ]Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time
- Volume of distribution (Vz) [ Time Frame: Every 21-day cycle throughout the study, for an average of 1 year. ]The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream.
- Terminal half-life [ Time Frame: Every 21-day cycle throughout the study, for an average of 1 year. ]Terminal elimination half-life is the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%
- Number of participants who develop anti-drug antibodies [ Time Frame: Throughout the study, up to 2 years ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05848011
Contacts
| Contact: Global Trial Manager | 301-251-5172 | info@macrogenics.com |
Locations
Show 51 study locations
Sponsors and Collaborators
MacroGenics
Investigators
| Study Director: | Denise Casey, M.D. | MacroGenics |
| Responsible Party: | MacroGenics |
| ClinicalTrials.gov Identifier: | NCT05848011 |
| Other Study ID Numbers: |
CP-MGD019-02 |
| First Posted: | May 8, 2023 Key Record Dates |
| Last Update Posted: | April 16, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Prednisone |
Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |