Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorigerlimab + Docetaxel and Prednisone | Experimental | 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). |
|
| Standard of care docetaxel and prednisone | Other | Docetaxel 75 mg/m^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lorigerlimab | Biological | Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pepi Pencheva, M.D. | MacroGenics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Medical Group | Miami | Florida | 33135 | United States | ||
| Orlando Health Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| docetaxel | Drug | Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer |
|
|
| Prednisone | Drug | A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Number of participants who develop anti-drug antibodies | Throughout the study, up to 2 years |
| Orlando |
| Florida |
| 32806 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Nebraska Cancer Specialists | Grand Island | Nebraska | 68803 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| START Mountain Region | West Valley City | Utah | 84119 | United States |
| University of Virginia Health System Cancer Center | Charlottesville | Virginia | 22903 | United States |
| Concord Repatriation General Hospital | Concord | Australia |
| Peter MacCallum Cancer Centre | North Melbourne | Australia |
| North Shore Private Hospital | St Leonards | Australia |
| Westmead Hospital | Westmead | Australia |
| Cliniques universitaires Saint-Luc (CUSL), Brussels | Brussels | Belgium |
| UZ GENT | Ghent | Belgium |
| Centre Hospital de l'Ardenne | Libramont | Belgium |
| CHU de Liège | Liège | Belgium |
| MHAT Dr. Tota Venkova | Gabrovo | Bulgaria |
| Comprehensive Cancer Center | Plovdiv | Bulgaria |
| UMHAT Sv. Ivan Rilski | Sofia | Bulgaria |
| Institut Bergonie | Bordeaux | France |
| Clinique Victor Hugo | Le Mans | France |
| Centre Léon Bérard | Lyon | 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 | France |
| LTD High Tech Hosp Medcenter | Batumi | Georgia |
| First University Clinic TSMU | Tbilisi | Georgia |
| LTD Consilium Medulla | Tbilisi | Georgia |
| Ltd Gidmedi | 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 | Georgia |
| Przychodnia Lekarska KOMED | Konin | Poland |
| Szpital Woj. im M Kopernika | Koszalin | Poland |
| Pratia McM Kraków | Krakow | Poland |
| Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina | Otwock | Poland |
| LuxMed Onkologia | Warsaw | Poland |
| Medical Concierge | Warsaw | Poland |
| Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., Oddział Chemioterapii | Warsaw | Poland |
| Pan American Center for Oncology Trials, LLC | Rio Piedras | Puerto Rico |
| H U Germans Tries i Pujol | Barcelona | Spain |
| Hospital Clínic de Barcelona | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Parc Tauli | Barcelona | Spain |
| Hospital Sant Pau | Barcelona | Spain |
| Institut Català d'Oncologia Hospitalet_ICO Hospitalet | Barcelona | Spain |
| Vall d' Hebron Institute of Oncology (VHIO) | Barcelona | Spain |
| Hospital 12 de octubre | Madrid | Spain |
| Hospital Universitario Virgen del Rocio | Seville | Spain |
| FIVO: Instituto Valenciano de Oncología | Valencia | Spain |
| Churchill Hospital | Headington | United Kingdom |
| Charing Cross Hospital | London | United Kingdom |
| Royal Marsden Hospital | Sutton | United Kingdom |
| Musgrove Park Hospital | Taunton | United Kingdom |
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided