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Angiogenesis Inhibitor

Triple-Drug Combo for Liver Cancer (RELATIVITY-106 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Must not have
Prior allogenic stem cell or solid organ transplantation
Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial will compare the safety and effectiveness of a three-drug combo of nivolumab, relatlimab, and bevacizumab versus a two-drug combo of just nivolumab and bevacizumab in people with HCC that has not yet been treated.

Who is the study for?
This trial is for adults with advanced liver cancer (HCC) who haven't had systemic therapy for it. They should have a good level of liver function (Child-Pugh A) and be able to carry out daily activities with little or no help (ECOG 0-1). People can't join if they've had organ transplants, certain types of HCC, untreated brain metastases, or significant fluid in the abdomen.
What is being tested?
The study tests combining Nivolumab and Relatlimab with Bevacizumab against just Nivolumab and Bevacizumab in treating advanced liver cancer. It aims to see which combination is safer and more effective for patients who haven't received prior treatment for their condition.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, increased bleeding risk due to Bevacizumab's effect on blood vessels, fatigue, skin issues, and potential impact on wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver function is slightly impaired.
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I am fully active or can carry out light work.
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My liver cancer is confirmed to be advanced or has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a previous organ or stem cell transplant.
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My liver cancer is a specific type (fibrolamellar, sarcomatoid, or mixed with bile duct cancer).
Select...
I have brain metastases that have not been treated and are causing symptoms.
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I have had or currently have serious fluid buildup in my abdomen needing treatment.

Timeline

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

Treatment Details

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: Placebo + Nivolumab + BevacizumabExperimental Treatment3 Interventions
Group II: Arm A: Relatlimab + Nivolumab + BevacizumabExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relatlimab
2019
Completed Phase 2
~1150
Nivolumab
2015
Completed Phase 3
~4010
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,686 Previous Clinical Trials
4,129,699 Total Patients Enrolled
21 Trials studying Hepatocellular Carcinoma
5,743 Patients Enrolled for Hepatocellular Carcinoma

Media Library

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05337137 — Phase 1 & 2
Hepatocellular Carcinoma Research Study Groups: Arm A: Relatlimab + Nivolumab + Bevacizumab, Arm B: Placebo + Nivolumab + Bevacizumab
Hepatocellular Carcinoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT05337137 — Phase 1 & 2
Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05337137 — Phase 1 & 2
~40 spots leftby Oct 2025
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