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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
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 below
Select...
My liver function is slightly impaired.
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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 weeks
Treatment ~ Varies
Follow Up ~assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 3 years for reporting.

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 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Superior vena cava syndrome
1%
Syncope
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Lung cancer metastatic
1%
Cancer pain
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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
~1110
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
2,631 Previous Clinical Trials
4,126,510 Total Patients Enrolled
23 Trials studying Hepatocellular Carcinoma
7,582 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the target number of patients for this clinical trial?

"The trial needs 162 patients that satisfy the basic requirements in order to start. The research will be conducted by Bristol-Myers Squibb at various hospitals, with some being Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland and Local Institution - 0025 in Edmonton, Alberta."

Answered by AI

Are we able to enroll new patients in this research project at this time?

"The study is still recruiting patients, as noted on the clinicaltrials.gov website. This particular trial was initially posted on May 5th, 2022 and has since been updated October 17th of the same year."

Answered by AI

How many hospitals are participating in this research project?

"There are a total of 17 sites running this study, including Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland, Local Institution - 0025 in Edmonton, Alberta, and California Pacific Hematology Oncology Associates in San Francisco, California."

Answered by AI
~13 spots leftby Jun 2024