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Nivolumab + BMS-986253 for Liver Cancer
Study Summary
This trial is testing whether two different drugs, when used together with a third drug, are more effective at shrinking tumors than the third drug used alone, in people with advanced liver 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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- I have lung disease that causes symptoms or could affect lung treatment.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I cannot undergo surgery or localized treatments for my condition.I am currently taking statins.My kidney function is good, with creatinine below 2.0 mg/Dl.I do not have any uncontrolled inflammatory diseases like Crohn's or ulcerative colitis.I have cancer that has spread to my brain.I have not had a transplant and do not have untreated severe varices.I am a woman who can have children and will take a pregnancy test before starting the study.I had major surgery more than 4 weeks ago and have recovered.I have not received a live vaccine in the last 30 days.My blood tests show enough neutrophils, platelets, and hemoglobin.I haven't taken herbal supplements or traditional medicines in the last 2 weeks.I am willing to provide tumor samples for study before and during treatment.I am not currently on any experimental drugs and haven't had any systemic therapy before signing up.I do not have uncontrolled brain function issues.I have fluid buildup in my abdomen that isn't managed.I have an autoimmune disease but it's under control or not expected to worsen.I have another cancer besides non-melanoma skin cancer or cervical carcinoma in situ, or I am considered at less than 30% risk of cancer relapse by my doctor.I do not have serious heart problems or uncontrolled infections.My liver cancer is confirmed and my liver function score is 7 or less.I have or had Tuberculosis.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I had treatments like radioembolization or radiation for my liver condition over 4 weeks ago and have mostly recovered.I have or had significant muscle disorders or recent muscle injuries.I have not received any live vaccines recently and will not for 100 days after my last treatment dose.I agree to use birth control and not donate sperm while on the study and for 7 months after.My liver is functioning within the required levels.I am on anti-viral therapy for hepatitis B.I am not pregnant or breastfeeding.
- Group 1: Nivolumab Monotherapy
- Group 2: Nivolumab/BMS-986253 combination
- Group 3: Nivolumab/Cabiralizumab combination
- 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 this an innovative research project?
"At present, there are 718 active clinical trials for Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks taking place across 49 nations and 2354 cities. The inaugural trial was established in 2012 by Ono Pharmaceutical Co. Ltd., involving 659 patients and reaching Phase 1 & 2 of drug approval. Since its inception 8 years ago, 251 studies have been completed successfully."
To what maladies is the combined administration of Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks typically applied?
"People battling malignant neoplasms, unresectable melanoma and squamous cell carcinoma can benefit from a therapy consisting of Nivolumab 240 mg IV dosage every two weeks in combination with Cabiralizumab 4 mg/kg IV administration also to be administered twice each month."
What prior research has been conducted on the efficacy of a regimen composed of Nivolumab 240 mg IV every two weeks + Cabiralizumab 4 mg/kg IV every two weeks?
"Nivolumab 240 mg IV in combination with Cabiralizumab 4 mg/kg IV every 2 weeks was first trialed by Local Institution back in 2012. After 251 completed trials, there are now 718 ongoing studies being conducted across New york City and its surrounding area."
How many participants are currently taking part in this trial?
"Unfortunately, this particular clinical trial has since concluded. Initially posted on the 12th of September 2019 and last edited on 28th of September 2022, it is no longer accepting applicants. However, there are numerous other studies looking for enrollees; 2604 trials targeting carcinoma patients and 718 trials solely examining Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks are currently open to participants."
Is recruitment now active for this experiment?
"This trial has ended its recruitment phase. Posting on September 12th 2019, the last update was made on 28th of September 2022. However, if you are keen to participate in other studies for carcinoma or Nivolumab 240mg IV and Cabiralizumab 4 mg/kg IV every 2 weeks then there are 2604 and 718 trials respectively that may be suitable for your needs."
Has the combination of Nivolumab 240 mg intravenously every 2 weeks plus Cabiralizumab 4 mg/kg intravenously every two weeks obtained FDA authorization?
"Our team evaluated the safety of Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4mg/kg IV every 2 weeks to be a score of two. This is due to it being in Phase 2, and thus only having some data validating its security but not any evidence for efficacy."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
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Most responsive sites:
- NYU Langone Health: < 48 hours
Average response time
- < 2 Days
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