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ZEN-3694 + Enzalutamide + Pembrolizumab for Prostate Cancer
Study Summary
This trial is testing a combination of drugs to treat patients with prostate cancer that has spread and is resistant to hormone therapy. The drugs work in different ways to attack the cancer cells.
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.Trial Design
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Who is running the clinical trial?
Media Library
- My prostate cancer is spreading despite hormone therapy.I haven't needed IV antibiotics for an infection in the last 7 days.I have or had lung inflammation that needed steroids.You are allergic to certain medications.I have previously been treated with immune checkpoint inhibitors.I have been treated with a BET inhibitor before.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My testosterone levels are very low, and I'm on hormone therapy if not surgically treated.I have been treated for an autoimmune disease in the last 2 years.I am mostly able to carry out my daily activities.I haven't had chemotherapy for advanced prostate cancer but may have had it earlier if it was more than 6 months ago.You do not have any of the specific changes mentioned above.My prostate cancer is getting worse according to tests.I haven't had cancer treatments except for LHRH analogues in the last 14 days or 5 half-lives, whichever is shorter, and my side effects from previous treatments are minimal.I am willing to have a biopsy of my cancer if needed, or I have recent biopsy samples.I have prostate cancer that has spread and is not responding to hormone therapy.My PSA level is over 2 ng/mL or my cancer can be measured using specific criteria.I have had no more than two chemotherapy treatments for my advanced prostate cancer.My heart condition meets specific health criteria.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I am 18 years old or older.I had radiotherapy over 2 weeks ago, have no side effects, and didn't need steroids.I haven't received any radiopharmaceutical treatments in the last 6 weeks.You have a disease that can be measured using specific criteria called RECIST 1.1.I have not had major surgery in the last 4 weeks.You have an ongoing hepatitis C virus infection shown by a positive viral test.I have another cancer but it's not being actively treated, except for certain skin, bladder cancers, or early-stage cancers.I have not received a live vaccine within the last 30 days.My prostate cancer has changed into a more aggressive form based on specific tests.I haven't taken any forbidden medications in the last week.I am currently taking enzalutamide and can continue without stopping before the study.My organ functions are within normal ranges according to recent tests.My hepatitis B virus load is undetectable.My cancer progressed despite treatment with medications like abiraterone.
- Group 1: Cohort B: mCRPC without evidence of transdifferentiation
- Group 2: Cohort A: Transdifferentiated mCRPC
- Group 3: Safety Cohort
- 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
What are the typical applications of Pembrolizumab?
"Pembrolizamab can target malignant neoplasms, microsatellite instability high and unresectable melanoma."
How many participants will be admitted to this clinical trial?
"Affirmative. Clinicaltrials.gov conveys that this clinical study, which debuted on January 26th 2021, is actively recruiting individuals to join the trial. A total of 54 participants are needed from 2 separate sites."
Is Pembrolizumab a dependable therapeutic option for patients?
"Power's internal assessment of Pembrolizumab gave it a rating of 2 due to limited data that suggests the drug is safe and no evidence indicating efficacy."
Is enrolment for this experiment still ongoing?
"Indeed, clinicaltrials.gov reveals that this medical study is currently recruiting patients with the trial having been initially posted on January 26th 2021. The most recent update was done on August 8th 2022 and 54 participants are sought from two different research sites."
Have there been any other investigations into the use of Pembrolizumab?
"Currently, 1050 different studies are using pembrolizumab as a drug intervention. Of those trials, 148 have progressed to Phase 3. Primarily based in Houston, Texas, there is an expansive network of 40727 sites running research with this medication."
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