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M7824, M9241, and SBRT for Genitourinary Cancer
Study Summary
This trial is testing if two drugs, M7824 and M9241, can help the immune system fight cancer when given with or without radiation therapy.
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 2023 Phase 1 & 2 trial • 21 Patients • NCT04247282Trial Design
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Who is running the clinical trial?
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- I am unwilling to receive blood products even if needed for my treatment.You have a condition that can be measured or evaluated by the doctors.I have had radiation therapy before, but not on the same area twice.I have advanced kidney cancer and cannot take standard treatments.I have at least one cancer spot that can be measured and won't be treated with radiation.I can take care of myself but might not be able to do heavy physical work.I am 18 years or older and have given my consent to participate.I have advanced testicular cancer and cannot have standard chemotherapy or a stem cell transplant.I have an autoimmune disease or have been treated with high-dose steroids or immunosuppressants.I have previously undergone chemotherapy or targeted therapy for my condition.I am on stable HCV treatment without significant liver issues.I have a recent tissue sample for PD-L1 testing or am willing to get a biopsy.I have a tumor in my liver or chest that is larger than 10 cm.I have no active cancer except for certain skin, cervical, or low-risk prostate cancers.I have hepatitis B and am on a stable dose of specific antivirals.I am HIV-positive, on stable HAART, with CD4 counts over 350 and an undetectable viral load.I had brain or CNS cancer treatment, am off steroids, and it's been 2 weeks since my last radiation.I do not have any severe illnesses or conditions that could interfere with the study.My hemoglobin level is at least 9g/dL, transfusions included.You have had allergic reactions to similar substances as the investigational drugs M7824 and/or M9241 used in the study.I have had immunotherapy but not with M7824 or M9241.I have advanced bladder cancer and cannot have or have already had certain chemotherapy or immunotherapy.I can have radiation on up to 4 areas of my cancer.I am not pregnant or breastfeeding.My liver tests are within the required limits for the study.My cancer has spread, confirmed by recent scans.I am willing to use effective birth control during and after the treatment for the specified periods.My cancer in the urinary system has spread and was confirmed by lab tests.My liver function is mildly to moderately impaired, with bilirubin levels not exceeding three times the upper limit.My organs and bone marrow are functioning well.
- Group 1: Arm 1
- Group 2: Arm 2
- Group 3: Arm 3
- 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 there any remaining openings for participants in this research project?
"Affirmative. According to the listing on clinicaltrials.gov, this medical trial was posted back in July 2020 and has since been actively recruiting patients. This study requires 66 participants from a single site."
Has the FDA sanctioned M7824 for public use?
"Based on the limited data available, our team at Power assessed the safety of M7824 as a 1. This is due to it being in Phase 1 of clinical trials and having only preliminary evidence supporting its efficacy and safety."
How many people are currently engaged in this trial?
"Indeed, the information on clinicaltrials.gov indicates that this research study is currently recruiting participants. It was first posted on July 13th 2020 and last revised on November 5th 2022 with 66 individuals needed from 1 site."
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