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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
My cancer has not spread outside the liver, to lymph nodes, or to both sides of the portal vein.
Select...
I am fully active or able to carry out light work.
Select...
My liver cancer can be surgically removed and meets specific diagnosis criteria.
Select...
My organ and bone marrow functions meet the required levels for the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who complete pre-op treatment and proceed to surgery
Secondary outcome measures
Disease free survival (DFS) at 12 months
Disease free survival (DFS) at 18 months
Disease free survival (DFS) at 3 years
+9 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%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
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%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
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
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
2014
Completed Phase 3
~4750
Relatlimab
2018
Completed Phase 2
~1120
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,900 Total Patients Enrolled
3 Trials studying Liver Cancer
144 Patients Enrolled for Liver Cancer
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,044 Total Patients Enrolled
6 Trials studying Liver Cancer
1,438 Patients Enrolled for Liver Cancer
Mark Yarchoan, MDPrincipal InvestigatorSKCCC Johns Hopkins Medical Institution
1 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with specific immune therapies before.You have a known or suspected allergic reaction to the study treatment.I am 18 years old or older.I am not taking high doses of steroids (> 10 mg/day of prednisone or equivalent).My heart's pumping ability is normal, confirmed by a test within the last 6 months.My liver cancer is either fibrolamellar or mixed HCC.My cancer has not spread outside the liver, to lymph nodes, or to both sides of the portal vein.I am fully active or able to carry out light work.My liver cancer can be surgically removed and meets specific diagnosis criteria.I have a serious heart condition.I have an immune system disorder or am on steroid treatment.I have a history of HIV infection.I am currently or have previously been treated with chemotherapy or experimental drugs for liver cancer.I have moderate to severe fluid buildup in my abdomen.I do not have any uncontrolled illnesses.The doctor will decide if you have any other medical, mental, or social reasons that make it not safe or appropriate for you to participate in the study.I have not taken systemic treatment for an autoimmune disease in the last 2 years.I am a woman who can have children and my pregnancy test is negative.You are not using illegal drugs or abusing substances.My liver is functioning well and has enough healthy tissue.I have had a transplant of tissue, organ, or bone marrow from another person.I have another cancer that won't need treatment in the next 2 years, except for certain low-risk types.I have both hepatitis B and D.I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.I do not have serious heart problems.I am not willing to use contraception during the trial.I am following recommended treatment for hepatitis B.My organ and bone marrow functions meet the required levels for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A - Nivolumab
- Group 2: Arm B - Nivolumab and Relatlimab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what general purpose is Nivolumab most often prescribed?
"Nivolumab is a medication that is approved for the treatment of malignant neoplasms. However, it has also been shown to be effective in treating other conditions like metastatic esophageal adenocarcinoma and unresectable melanoma."
Answered by AI
Are there any other similar medical studies to this one involving Nivolumab?
"As of now, there are 754 active research projects being conducted that involve Nivolumab. 83 of those studies have advanced to Phase 3 clinical trials. The majority of these trials are taking place in Ciudad de Mexico and Maryland; however, there are 40598 total research locations for this treatment."
Answered by AI
What other research is like this one in terms of topic and scope?
"Nivolumab has been under clinical scrutiny since 2010. After the first 127-person study concluded, it received Phase 1 drug approval in 2010. Currently, there are 754 active clinical trials involving Nivolumab across 50 countries and 2358 cities."
Answered by AI
Nivolumab has received FDA support, correct?
"While there is only limited data backing up the efficacy and safety of Nivolumab, our team still believes that it is a safe medication."
Answered by AI
Are we still accepting people into this research project?
"Yes, this trial is still ongoing and looking for participants. The listing was first posted on May 28th, 2021 and was most recently updated on March 3rd, 2022."
Answered by AI
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