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Combination Immunotherapy for Prostate Cancer
Study Summary
This trial is studying a combination of three drugs as a possible treatment for people with prostate cancer.
Timeline
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?
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- I am not taking medications like finasteride or saw palmetto that affect PSA levels.You are allergic to eggs or certain antibiotics like gentamicin or tobramycin.I am HIV positive.I haven't taken daily steroids for more than 2 weeks in the last month.I have had my spleen removed.Your immune system is weakened due to:I have an active autoimmune disease like lupus or thyroiditis.I have an autoimmune disease that hasn't needed strong medication or endangered my organs.I have a condition that weakens my immune system.I have not had an organ transplant that requires immunosuppression.I have had a severe allergic reaction to monoclonal antibodies.You had allergic reactions in the past to vaccines that are similar to the poxviral vaccine (like the vaccinia vaccine).I have not had major surgery in the last 4 weeks.I have a history of skin conditions like eczema.I have had chemotherapy before for my condition.I am fully active or can carry out light work.I have not had a recent serious heart or stroke issue.I have not received a blood transfusion in the last 2 weeks.I am willing to accept blood products if needed.I am mostly self-sufficient and can carry out daily activities.I have recovered from the side effects of my last cancer treatment.I haven't had any other cancers except for non-dangerous skin cancer or bladder cancer in the last 3 years.I agree to use effective contraception during and for four months after the study.My liver is functioning well enough for treatment.My PSA levels are rising after prostate surgery, currently above 0.8 ng/mL.I agree to continue hormone therapy for my cancer.This study is specifically looking for participants who have experienced a recurrence of their disease based on certain biochemical markers.I haven't had immunotherapy in the last 3 years, except as part of a specific group in a study.My PSA levels have been rising over time, following specific treatment guidelines.My kidneys are working well, with a creatinine clearance over 50 mL/min.I have a tumor in my liver or chest that is 10 cm or larger.My PSA levels have increased by 2 ng/mL or more after radiation therapy.My prostate cancer has spread to my bones or lymph nodes.My PSA levels have been increasing over the last month.I am 18 years old or older.My cancer is getting worse despite low testosterone levels.You have had serious side effects from a smallpox vaccine in the past.
- Group 1: 1/combination therapy (closed December 2018)
- Group 2: 2/combination therapy + surveillance (closed)
- Group 3: 3/combination vaccine therapy +/- surveillance
- 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
Could you provide the potential risks of administering MSB0011359C (M7824) to patients?
"The safety of MSB0011359C (M7824) was considered to be a 2 out of 3 on the scale due to Phase 2 trial data indicating that this medication has some evidence supporting its safety, though no efficacy studies exist."
What is the scope of patient participation in this clinical trial?
"Affirmative. Clinicaltrials.gov is currently listing this research project which was initially posted on March 20th 2018 and recently updated in October 19th 2022. Forty participants are needed from a single medical center."
Are there still vacancies for patients to participate in this experiment?
"Affirmative. Details available on clinicaltrials.gov indicate that this research trial, which was initially published in March 2018, is still enrolling participants. 40 people are being sought for the study at a single location."
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