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Checkpoint Inhibitor

Nivolumab +/− Relatlimab for Liver Cancer

Phase 1
Recruiting
Led By Mark Yarchoan, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old on the day of consent.
No extrahepatic spread, no nodal disease, and no bilateral left and right branch portal vein involvement.
Must not have
Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies.
Systemic or topical corticosteroids at immunosuppressive doses (> 10 mg/day of prednisone or equivalent).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combo to see if it's safe and effective.

Who is the study for?
This trial is for adults with Hepatocellular Carcinoma (HCC) that can potentially be removed by surgery. Participants should have good performance status, no spread of cancer outside the liver, and meet specific heart function criteria. They must not have had prior systemic chemotherapy or certain immunotherapies for HCC, nor should they have other significant health issues like uncontrolled diseases or a history of HIV.
What is being tested?
The study tests the safety and effectiveness of Nivolumab alone or combined with Relatlimab before and after surgery in patients with HCC. It aims to see how well these drugs work when given around the time of tumor removal.
What are the potential side effects?
Potential side effects include immune-related reactions affecting various organs, infusion-related symptoms, fatigue, skin problems, hormonal gland issues such as thyroid dysfunction, and possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer has not spread outside the liver, to lymph nodes, or to both sides of the portal vein.
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I am fully active or able to carry out light work.
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My liver cancer can be surgically removed and meets specific diagnosis criteria.
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My organ and bone marrow functions meet the required levels for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with specific immune therapies before.
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I am not taking high doses of steroids (> 10 mg/day of prednisone or equivalent).
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My liver cancer is either fibrolamellar or mixed HCC.
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I have a serious heart condition.
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I have an immune system disorder or am on steroid treatment.
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I have a history of HIV infection.
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I am currently or have previously been treated with chemotherapy or experimental drugs for liver cancer.
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I have moderate to severe fluid buildup in my abdomen.
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I have not taken systemic treatment for an autoimmune disease in the last 2 years.
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I have had a transplant of tissue, organ, or bone marrow from another person.
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I have both hepatitis B and D.
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I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.
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I do not have serious heart problems.
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I am not willing to use contraception during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Disease free survival (DFS) at 12 months
Disease free survival (DFS) at 18 months
Disease free survival (DFS) at 3 years
+7 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B - Nivolumab and RelatlimabExperimental Treatment2 Interventions
Participants receive Nivolumab and Relatlimab.
Group II: Arm A - NivolumabExperimental Treatment1 Intervention
Participants receive Nivolumab only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Relatlimab
2019
Completed Phase 2
~1150

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,210 Total Patients Enrolled
3 Trials studying Liver Cancer
144 Patients Enrolled for Liver Cancer
Bristol-Myers SquibbIndustry Sponsor
2,686 Previous Clinical Trials
4,129,841 Total Patients Enrolled
6 Trials studying Liver Cancer
1,439 Patients Enrolled for Liver Cancer
Mark Yarchoan, MDPrincipal InvestigatorSKCCC Johns Hopkins Medical Institution
1 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04658147 — Phase 1
Liver Cancer Research Study Groups: Arm A - Nivolumab, Arm B - Nivolumab and Relatlimab
Liver Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04658147 — Phase 1
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04658147 — Phase 1
~2 spots leftby Jun 2025
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