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Monoclonal Antibodies
Nivolumab + BMS-986253 for Liver Cancer
Phase 2
Waitlist Available
Led By Nina Beri, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Deemed to not be a candidate for resection or other local-regional therapy
Adequate renal function: Creatinine < 2.0 mg/Dl
Must not have
Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
Concomitant use of statins while on study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adults with advanced liver cancer (HCC) who haven't had other systemic treatments. They must have a Childs-Pugh score ≤7, adequate organ function, and no history of certain conditions like tuberculosis or uncontrolled heart disease. Participants need to agree to contraception methods if applicable and can't be pregnant or breastfeeding.
What is being tested?
The study tests if adding BMS-986253 or Cabiralizumab to Nivolumab improves response rates in HCC patients compared to Nivolumab alone. It's a phase II trial with three groups: one receiving just Nivolumab, and the others each combining it with one of the additional drugs.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, increased risk of infections due to weakened immunity, potential liver issues given the nature of the drugs involved, fatigue, and possibly digestive disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot undergo surgery or localized treatments for my condition.
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My kidney function is good, with creatinine below 2.0 mg/Dl.
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My blood tests show enough neutrophils, platelets, and hemoglobin.
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I am not currently on any experimental drugs and haven't had any systemic therapy before signing up.
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My liver cancer is confirmed and my liver function score is 7 or less.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My liver is functioning within the required levels.
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I am on anti-viral therapy for hepatitis B.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have lung disease that causes symptoms or could affect lung treatment.
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I am currently taking statins.
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I do not have any uncontrolled inflammatory diseases like Crohn's or ulcerative colitis.
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I have cancer that has spread to my brain.
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I have not had a transplant and do not have untreated severe varices.
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I had major surgery more than 4 weeks ago and have recovered.
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I haven't taken herbal supplements or traditional medicines in the last 2 weeks.
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I do not have uncontrolled brain function issues.
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I have fluid buildup in my abdomen that isn't managed.
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I do not have serious heart problems or uncontrolled infections.
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I have or had Tuberculosis.
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I have or had significant muscle disorders or recent muscle injuries.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab/Cabiralizumab combinationExperimental Treatment2 Interventions
Group II: Nivolumab/BMS-986253 combinationExperimental Treatment2 Interventions
Group III: Nivolumab MonotherapyActive Control1 Intervention
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,562 Total Patients Enrolled
Nina Beri, MDPrincipal InvestigatorNYU Langone Health
Theodore Welling, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab Monotherapy
- Group 2: Nivolumab/BMS-986253 combination
- Group 3: Nivolumab/Cabiralizumab combination
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Liver Cancer Patient Testimony for trial: Trial Name: NCT04050462 — Phase 2
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