Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 3 years
Awards & highlights
RELATIVITY-106 Trial 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.Check my eligibility
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.See study design
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.
RELATIVITY-106 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function is slightly impaired.
Select...
I am fully active or can carry out light work.
Select...
My liver cancer is confirmed to be advanced or has spread.
RELATIVITY-106 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities (DLTs)
Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary outcome measures
Number of participants with adverse events (AEs)
ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive
OS of all randomized participants that are LAG-3 positive
+3 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
RELATIVITY-106 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
2018
Completed Phase 2
~1120
Nivolumab
2014
Completed Phase 3
~4750
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,670 Total Patients Enrolled
23 Trials studying Hepatocellular Carcinoma
7,582 Patients Enrolled for Hepatocellular Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function is slightly impaired.I have not had systemic therapy for advanced liver cancer, but prior immunotherapy is okay if my cancer returned 6 months after treatment.I am fully active or can carry out light work.My liver cancer is confirmed to be advanced or has spread.I have had a previous organ or stem cell transplant.My liver cancer is a specific type (fibrolamellar, sarcomatoid, or mixed with bile duct cancer).I have brain metastases that have not been treated and are causing symptoms.I have had or currently have serious fluid buildup in my abdomen needing treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Relatlimab + Nivolumab + Bevacizumab
- Group 2: Arm B: Placebo + Nivolumab + Bevacizumab
Awards:
This trial has 0 awards, including: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.
Share this study with friends
Copy Link
Messenger