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Anti-tumor antibiotic

Lorigerlimab + Docetaxel for Prostate Cancer

Phase 2

Recruiting

Research Sponsored by MacroGenics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.

Awards & highlights

Study Summary

This trial will test if lorigerlimab prolongs how long before mCRPC progresses when given with docetaxel+prednisone, compared to docetaxel+prednisone alone.

Who is the study for?

This trial is for men with advanced prostate cancer that's resistant to hormone therapy and has spread. They should have tried at least one but no more than two previous treatments targeting the androgen receptor, like abiraterone or enzalutamide. If they have a BRCA mutation, they must have been treated with PARP inhibitors. Participants need to be in good physical condition with a decent life expectancy and acceptable lab results.Check my eligibility

What is being tested?

The study is testing if adding Lorigerlimab to the standard treatment of Docetaxel and Prednisone can slow down cancer progression in metastatic castration-resistant prostate cancer patients. Patients will be randomly assigned (2:1) to either receive this combination or just Docetaxel and Prednisone.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation by Lorigerlimab such as inflammation, fatigue, digestive issues; plus those from chemotherapy like hair loss, nausea, low blood cell counts increasing infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Median radiographic progression free survival (rPFS) determined by investigator review.

Secondary outcome measures

Clearance (CL)

Description of types of adverse events (AEs) between treatment groups.

Duration of PSA response

+18 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of care docetaxel and prednisoneExperimental Treatment2 Interventions

Docetaxel 75 mg/m^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months)

Group II: Lorigerlimab + Docetaxel and PrednisoneExperimental Treatment3 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

docetaxel

2015

Completed Phase 3

~7230

Prednisone

2014

Completed Phase 4

~2370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor

48 Previous Clinical Trials

5,226 Total Patients Enrolled

Denise Casey, M.D.Study DirectorMacroGenics

1 Previous Clinical Trials

278 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities to get involved in this experiment?

"The records posted on clinicaltrials.gov affirm that this trial is no longer recruiting patients. This research endeavour, which was first published on September 1st 2023, has been updated as recently as the 6th of September and is not presently open for enrollment. However, there are 1333 other ongoing trials seeking candidates at present."

Answered by AI

Has the combination of Lorigerlimab, Docetaxel and Prednisone been approved by the FDA?

"There is only limited information about the safety of Lorigerlimab + Docetaxel and Prednisone, so it was given a rating of 2. This medication has not been tested for efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

2023. "A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05848011.

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