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Pembrolizumab for Prostate Cancer (CHOMP Trial)
CHOMP Trial Summary
This trial is testing the efficacy of pembrolizumab, a checkpoint inhibitor, in Veterans with metastatic castration-resistant prostate cancer. The study will also compare the pre-treatment and at-progression metastatic tumor biopsies to investigate the molecular correlates of resistance and sensitivity to pembrolizumab.
CHOMP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCHOMP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183CHOMP Trial Design
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Who is running the clinical trial?
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- My cancer has spread to my brain.I have been tested for hepatitis B or C.My prostate cancer is worsening despite low testosterone levels.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I have used AR signaling inhibitors for my prostate cancer.I had radiotherapy over 2 weeks ago and have no side effects needing steroids.I finished cancer treatment for prostate cancer more than 2 weeks ago, and chemotherapy more than 4 weeks ago.My liver function tests are within the required range.My prostate cancer is identified as adenocarcinoma or small cell type.I am undergoing treatment to lower my testosterone levels below 50 ng/dL.My cancer has spread, confirmed by specific scans within the last 2 months.I have not received a live vaccine in the last 30 days.My cancer involves changes in specific genes (MLH1, MSH2, MLH3, PMS1, MSH6, PMS2).I am highly allergic to pembrolizumab or its ingredients.I am 18 years old or older.I have an active tuberculosis infection.I am undergoing treatment to lower my testosterone levels below 50 ng/dL.My kidney function is within the required range for the study.I have a metastatic lesion that can be biopsied and was or will be biopsied within the last 6 months.I have been treated with specific immune therapy drugs before.I have had or currently have lung inflammation treated with steroids.My cancer has specific genetic features related to MMR genes and is MSI-H.My cancer has specific genetic changes, either in MMR genes or CDK12.My prostate cancer is worsening despite low testosterone, and I've used specific prostate cancer medications for at least 4 weeks.My cancer has spread, confirmed by a scan within the last 2 months.I am currently being treated for an infection with antibiotics.My organs are functioning well.I can carry out all my daily activities without help.I am 18 years old or older.My prostate cancer is diagnosed as adenocarcinoma or small cell.I have a metastatic lesion that can be biopsied and was biopsied within the last 6 months.I have been treated with specific prostate cancer medications for at least 4 weeks.My cancer has grown or spread according to recent scans.I haven't needed treatment for any cancer other than prostate, non-muscle invasive bladder, or non-melanoma skin cancer in the last 2 years.My cancer has specific genetic changes (dMMR or CDK12-/-).I have an autoimmune disease or have taken immunosuppressive drugs in the last 2 years.I can do all my usual activities without help.I haven't taken high doses of steroids or similar medications in the last 2 weeks.My genetic test shows changes in the CDK12 gene.My cancer has a specific genetic feature related to MMR genes.I am not using herbal products that could lower my PSA levels, except for megestrol for hot flashes.I have recovered from side effects of past treatments, except for mild neuropathy.I have recovered from major surgery complications within the last 4 weeks.
- Group 1: Single Arm
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Are additional participants being welcomed into this experiment?
"Affirmative. Clinicaltrials.gov hosts data indicating that, having been initially posted on February 20th 2020, this clinical trial is in pursuit of 30 participants from 12 different medical sites."
How many subjects can be enrolled in this research program?
"Affirmative. Clinicaltrials.gov reveals that this medical trial is currently recruiting patients, which began back on February 20th 2020 and was recently updated on October 19th 2022. The research team requires 30 participants to be enrolled across 12 sites nationwide."
How many health care centers in North America are hosting this research project?
"This clinical trial is open at Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA in Pennsylvania; the VA Central Office located Washington DC; Hunter Holmes McGuire VA Medical Center situated in Richmond, Virginia and an additional 12 sites across America."
Has Pembrolizumab been explored in any other research projects?
"Since it was first studied in 2010 at City of Hope, pembrolizumab has featured in 251 completed trials and 961 active ones. A significant concentration of these tests are taking place within Philadelphia, Pennsylvania."
Is Pembrolizumab efficacious enough to be relied upon with confidence?
"Due to the limited efficacy data and existing safety evidence, our team at Power assigned Pembrolizumab a score of 2."
What is the primary purpose of this investigation?
"The primary end-point of this clinical trial, measured from the first day of pembrolizumab administration to 6 months later, is PSA Decline. Secondary outcomes include Overall Survival (time from enrolment until death), Time to Progression of Disease (Time to PSA progression and initiation of alternative anti-neoplastic therapy or radiographic progression) as well as Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] which gauges the safety profile of pembrolizumab in these patients with prostate cancer by evaluating adverse events experienced."
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