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Immunotherapy + SBRT for Solid Cancers
Study Summary
This trial is testing a combination of two immunotherapy drugs, nivolumab and anti-IL-8, with radiation to see if it is safe and if it can help treat 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.Trial Design
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Who is running the clinical trial?
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- You have a certain level of IL-8 in your blood at the start of the study.I have specific health conditions or cancers.You have a current, known, or suspected autoimmune disease.I am using effective birth control if I can have children or am sexually active.I have 1-4 tumors that can be safely treated with radiation.I am fully active or restricted in physically strenuous activity but can do light work.I have not had chemotherapy, immunotherapy, or radiation recently.My advanced cancer has not responded to standard treatments.I am fully active or restricted in physically strenuous activity but can do light work.I am currently on medication to suppress my immune system.My organ and bone marrow functions are normal.I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.I am currently being treated for an infection.You are currently taking any experimental drugs.I am 18 years old or older.My cancer can be measured by tests or scans.I do not have major heart problems.You are pregnant, breastfeeding, or able to become pregnant.You have a high level of a substance called IL-8 in your blood before starting the study.I can follow all treatment and activity guidelines.I have 1 to 4 tumors that can be safely treated with radiation.You have had allergic reactions to similar drugs as nivolumab and BMS-986253.I cannot have blood drawn or tolerate needles in my veins.You are required to stay in a treatment facility.I have had a severe reaction to previous immune therapy.My cancer can be measured by tests or scans.My organs and bone marrow are functioning normally.My melanoma or kidney cancer has not responded to anti-PD1/PDL1 treatment.My cancer has not spread to my brain, or if it has, it meets certain exceptions.I am 18 years old or older.
- Group 1: Nivolumab (Anti-PD-1) + BMS-986253 (Anti-IL-8) + SBRT
- 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
Is recruitment still possible for this research endeavor?
"According to the data hosted on clinicaltrials.gov, this medical study is actively enrolling patients. The initial posting of the trial was October 8th 2021 and it has since been revised in April 19th 2022."
What primary purpose does BMS-986253 serve for medical practitioners?
"BMS-986253 has been demonstrated to be efficacious at treating malignant neoplasms, unresectable melanoma, and squamous cell carcinomas."
Has BMS-986253 ever been tested in a prior medical experiment?
"At this moment, 717 research studies are underway concerning BMS-986253. Of those ongoing trials, 82 have reached Phase 3 and the primary investigation hub is in Basel, BE. There are 40281 medical centres across the globe administering tests for this treatment."
Has BMS-986253 received regulatory clearance from the FDA?
"The limited clinical data available suggests that BMS-986253 is relatively safe, thus receiving a score of 1."
Is this trial a pioneering venture in its field?
"Presently, 717 studies of BMS-986253 are ongoing in 2356 cities across 49 countries. Ono Pharmaceutical Co. Ltd first conducted a trial for the drug back in 2012; this initial study involved 659 patients and completed both Phase 1 & 2 clinical evaluation stages. Since then, 258 follow-up investigations have been concluded."
How many participants are engaged in this experiment?
"Affirmative. Information hosted on clinicaltrials.gov attests that this clinical study, which was originally made available on October 8th 2021, is currently welcoming applicants. The project requires 50 participants from 1 medical centre to be enrolled."
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