Your session is about to expire
← Back to Search
Apalutamide + Cetrelimab for Prostate Cancer
Study Summary
This trial is testing whether combining apalutamide with cetrelimab will result in a better response rate for men with metastatic castration-resistant prostate cancer who have evidence of treatment-emergent small cell neuroendocrine prostate cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 86 Patients • NCT03279250Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I had radiotherapy less than 2 weeks before starting the trial.I haven't had cancer treatments except for LHRH analogues in the last 14 days or 5 half-lives, and my side effects from previous treatments are minimal.My PSA level is over 2 ng/mL or my cancer can be measured by scans.I have had only one taxane-based chemotherapy for advanced prostate cancer.My cancer progressed despite treatment with drugs like abiraterone.I am willing to have a biopsy of my cancer if I haven't had one before.I am HIV positive without effective treatment and have had an undetectable viral load for 6 months.I do not have another cancer that needs treatment during this study.I am not on high-dose steroids or other drugs that weaken my immune system.I am currently taking apalutamide and can continue without stopping.I have had pneumonitis treated with steroids or currently have it.I have not received a live vaccine in the last 30 days.I am 18 years old or older.My prostate cancer has spread and is resistant to hormone therapy.You are allergic to cetrelimab or apalutamide.I have not needed IV antibiotics for an infection in the last week.My testosterone levels are very low, and I am on or will stay on hormone therapy if I haven't had surgery to remove my testicles.I have a digestive condition that affects how my body absorbs nutrients.I have previously received treatments targeting my immune system.I am fully active or can carry out light work.My prostate cancer is a specific type called 'small cell carcinoma' from the start.My prostate cancer has worsened recently.I have a heart condition.I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.I have an active hepatitis B or C infection with a detectable viral load.I have not taken any forbidden medications in the last week.I have not had major surgery in the last 4 weeks.My prostate cancer has changed into a more aggressive form with specific genetic changes.I have had seizures or a condition that could lead to seizures.My organ functions are within normal ranges according to recent tests.
- Group 1: Single Arm: Apalutamide + Cetrelimab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people are being selected for this opportunity?
"Yes, the trial is still open and recruiting patients according to the latest update on clinicaltrials.gov. The study was first posted on March 16th, 2022 and was last updated on March 21st, 2022. 24 participants are needed in total, at one location."
Are people still able to enroll in this research project?
"The latest information on clinicaltrials.gov suggests that this study is still recruiting patients. The original posting date was March 16th, 2022 and the site has been updated as recently as March 21st, 2022."
Is this a new or existing study?
"Apalutamide has been the focus of medical research since 2013 when the first study, sponsored by Aragon Pharmaceuticals, was completed. With 1207 participants, this initial trial led to Apalutamide being approved for phase 3 drug trials. Currently, there are 53 active studies in progress involving Apalutamide across 588 cities and 46 countries."
Is there any previous research on Apalutamide?
"Currently, there are 53 different clinical trials underway for Apalutamide. Out of those, 17 have reached Phase 3 status. The primary location for these studies is Linz, North Rhine-Westfalia; however, there are 3751 total locations running these trials."
Has Apalutamide been cleared for use in the United States?
"Apalutamide's safety is based off of Phase 2 trial data, meaning that while there is some indication of safety, there is no proof of efficacy."
Share this study with friends
Copy Link
Messenger