Androgen-Independent Prostatic CancerPhase 2NCT05848011
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study testing lorigerlimab, docetaxel and Prednisone in people with Androgen-Independent Prostatic Cancer and Androgen-Independent Prostatic Neoplasms, run by MacroGenics at 61 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Androgen-Independent Prostatic Cancer, Androgen-Independent Prostatic Neoplasms, Prostate Cancer Recurrent
- What is being tested?
- lorigerlimab, docetaxel and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 61 sitesin 10 countries
- Study dates
- 28 Sep 2023to 16 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
61 sites in 10 countries.
61 sites in 10 countries
United States10 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Virginia Health System Cancer Center
Charlottesville, Virginia, 22903
Nebraska Cancer Specialists
Grand Island, Nebraska, 68803
MD Anderson Cancer Center
Houston, Texas, 77030
United Medical Group
Miami, Florida, 33135
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Orlando Health Cancer Institute
Orlando, Florida, 32806
SUNY Upstate Medical University
Syracuse, New York, 13210
START Mountain Region
West Valley City, Utah, 84119
France10 sites
Institut Bergonie
Bordeaux
Clinique Victor Hugo
Le Mans
Centre Léon Bérard
Lyon
Centre Antoine Lacassagne
Nice
Institut Mutualiste Montsouris
Paris
Centre Hospitalier Quimper
Quimper
CHP Saint Grégoire
Saint-Grégoire
Hia Begin
Saint-Mandé
Hopital Foch
Suresnes
Institut Gustave Roussy
Villejuif
Spain10 sites
H U Germans Tries i Pujol
Barcelona
Hospital Clínic de Barcelona
Barcelona
Hospital del Mar
Barcelona
Hospital Parc Tauli
Barcelona
Hospital Sant Pau
Barcelona
Institut Català d'Oncologia Hospitalet_ICO Hospitalet
Barcelona
Vall d' Hebron Institute of Oncology (VHIO)
Barcelona
Hospital 12 de octubre
Madrid
Hospital Universitario Virgen del Rocio
Seville
FIVO: Instituto Valenciano de Oncología
Valencia
Georgia8 sites
LTD High Tech Hosp Medcenter
Batumi
First University Clinic TSMU
Tbilisi
LTD Consilium Medulla
Tbilisi
Ltd Gidmedi
Tbilisi
LtD L.M.National Urology Center
Tbilisi
LTD MMT Hospital
Tbilisi
LTD Todua Clinic
Tbilisi
Onc. Scient. Research Center
Tbilisi
Poland7 sites
Przychodnia Lekarska KOMED
Konin
Szpital Woj. im M Kopernika
Koszalin
Pratia McM Kraków
Krakow
Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
Otwock
LuxMed Onkologia
Warsaw
Medical Concierge
Warsaw
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., Oddział Chemioterapii
Warsaw
Australia4 sites
Concord Repatriation General Hospital
Concord
Peter MacCallum Cancer Centre
North Melbourne
North Shore Private Hospital
St Leonards
Westmead Hospital
Westmead
Belgium4 sites
Cliniques universitaires Saint-Luc (CUSL), Brussels
Brussels
UZ GENT
Ghent
Centre Hospital de l'Ardenne
Libramont
CHU de Liège
Liège
United Kingdom4 sites
Churchill Hospital
Headington
Charing Cross Hospital
London
Royal Marsden Hospital
Sutton
Musgrove Park Hospital
Taunton
Bulgaria3 sites
MHAT Dr. Tota Venkova
Gabrovo
Comprehensive Cancer Center
Plovdiv
UMHAT Sv. Ivan Rilski
Sofia
Puerto Rico1 site
Pan American Center for Oncology Trials, LLC
Rio Piedras
About this study
Official title: A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
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.
- Conditions
- Androgen-Independent Prostatic Cancer, Androgen-Independent Prostatic Neoplasms, Prostate Cancer Recurrent, Androgen-Insensitive Prostatic Cance, Androgen-Resistant Prostatic Cancer, Hormone Refractory Prostatic Cancer
- Being tested
- lorigerlimab, docetaxel, Prednisone
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorigerlimabBiological
Also called MGD019
Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4
docetaxelDrug
Also called Taxotere®
Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer
PrednisoneDrug
A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: lorigerlimab; Drug: docetaxel; Drug: Prednisone |
| 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) Receives: Drug: docetaxel; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
Secondary outcomes (21)
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
Measured: Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
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.
Measured: 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).
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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%
Measured: Every 21-day cycle throughout the study, for an average of 1 year.
Number of participants who develop anti-drug antibodies
Measured: Throughout the study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start28 Sep 2023
- Primary completion19 Feb 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgen-Independent Prostatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pepi Pencheva, M.D., Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848011
- Sponsor's protocol ID
- CP-MGD019-02
- Status last verified
- May 2026
- First submitted
- 17 Apr 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT05848011
- Acronym / sponsor ID
- CP-MGD019-02
- Conditions
- Androgen-Independent Prostatic Cancer, Androgen-Independent Prostatic Neoplasms, Prostate Cancer Recurrent, Androgen-Insensitive Prostatic Cance, Androgen-Resistant Prostatic Cancer, Hormone Refractory Prostatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorigerlimab + Docetaxel and Prednisone | Experimental | Biological: lorigerlimab, Drug: docetaxel, Drug: PrednisoneLorigerlimab 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 | Drug: docetaxel, Drug: PrednisoneDocetaxel 75 mg/m^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lorigerlimabAlso: MGD019Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4 | Biological | Lorigerlimab + Docetaxel and Prednisone |
| docetaxelAlso: Taxotere®Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer | Drug | Lorigerlimab + Docetaxel and Prednisone, Standard of care docetaxel and prednisone |
| PrednisoneA corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer | Drug | Lorigerlimab + Docetaxel and Prednisone, Standard of care docetaxel and prednisone |
Primary outcome
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.
21 secondary outcomes
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
Duration of response (DoR)
Time frame: Every 9 weeks for the first year, then every 12 weeks for up to 4 years
Time to response (TTR)
Time frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years
PSA50 response rate
Time frame: Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
PSA90 response rate
Time frame: Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years
Time to PSA progression
Time frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years
Duration of PSA response
Time frame: Every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.
Overall survival (OS)
Time frame: Throughout the study up to 4 years
Time to First Symptomatic Skeletal Event (SSE)
Time frame: Throughout the study up to 4 years
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
Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire
Time frame: Every 3 weeks up to 2 years
Pain interference using the BPI-sf questionnaire
Time frame: Every 3 weeks up to 2 years
Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire
Time frame: Every 3 weeks up to 2 years
Description of types of adverse events (AEs) between treatment groups.
Time frame: Throughout treatment up to 27 months
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.
Lorigerlimab area under the concentration time curve (AUC)
Time frame: Every 21-day cycle throughout the study, for an average of 1 year.
Trough drug concentration (Ctrough or Cmin)
Time frame: Every 21-day cycle throughout the study, for an average of 1 year.
Clearance (CL)
Time frame: Every 21-day cycle throughout the study, for an average of 1 year.
Volume of distribution (Vz)
Time frame: Every 21-day cycle throughout the study, for an average of 1 year.
Terminal half-life
Time frame: Every 21-day cycle throughout the study, for an average of 1 year.
Number of participants who develop anti-drug antibodies
Time frame: Throughout the study, up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pepi Pencheva, M.D. study director
MacroGenics
61 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lorigerlimab, docetaxel and Prednisone in people with Androgen-Independent Prostatic Cancer and Androgen-Independent Prostatic Neoplasms, run by MacroGenics at 61 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, France, Spain, Georgia, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.