Nivolumab for Stage IVB Hepatocellular Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, FLStage IVB Hepatocellular Carcinoma+10 MoreNivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether two immunotherapy drugs can help shrink tumors in patients with liver cancer that has spread.

Eligible Conditions
  • Stage IVB Hepatocellular Carcinoma
  • Hepatocellular Carcinoma (HCC)
  • Liver Cancer
  • Stage III Liver Cancer
  • Stage IIIA Hepatocellular Carcinoma
  • Stage IIIB Hepatocellular Carcinoma
  • Stage IV Liver Cancer
  • Stage IVA Hepatocellular Carcinoma
  • Unresectable Liver Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Meclizine Oral Tablet
1
Durvalumab
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Nivolumab

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Year 2
Overall survival (OS)
Progression-free survival (PFS)
Up to 2 years
Disease control
Incidence of adverse events
Up to 6 months
Heart rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
Meclizine Oral Tablet
1
Durvalumab
1
Nivolumab

Side Effects for

Investigator Choice of Chemotherapy
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%Thrombocytopenia
15%Insomnia
14%Weight decreased
14%Hyponatraemia
14%Rash
14%Platelet count decreased
13%Blood creatinine increased
13%White blood cell count decreased
12%Pain in extremity
12%Pruritus
12%Hypokalaemia
12%Abdominal pain
11%Alanine aminotransferase increased
11%Aspartate aminotransferase increased
11%Myalgia
10%Pneumonia
10%Muscular weakness
10%Productive cough
10%Alopecia
10%Dry skin
10%Chest pain
10%Hypoalbuminaemia
10%Dysgeusia
9%Abdominal pain upper
9%Mucosal inflammation
9%Hypothyroidism
9%Upper respiratory tract infection
9%Peripheral sensory neuropathy
8%Lacrimation increased
8%Non-cardiac chest pain
8%Nasopharyngitis
8%Dysphonia
8%Epistaxis
8%Haemoptysis
8%Stomatitis
7%Hyperkalaemia
7%Dehydration
7%Bronchitis
7%Anxiety
7%Hypertension
7%Chills
7%Blood alkaline phosphatase increased
7%Hyperglycaemia
7%Lymphocyte count decreased
6%Pneumonitis
6%Neuropathy peripheral
6%Oropharyngeal pain
6%Pleural effusion
6%Hypophosphataemia
6%Leukopenia
5%Dry mouth
5%Malaise
5%Pain
5%Urinary tract infection
5%Muscle spasms
5%Gamma-glutamyltransferase increased
5%Depression
5%Hypotension
5%Rash maculo-papular
5%Dyspepsia
5%Musculoskeletal chest pain
4%Fall
4%Pulmonary embolism
3%Myocardial infarction
3%Metastases to central nervous system
3%Musculoskeletal pain
3%Chronic obstructive pulmonary disease
3%Febrile neutropenia
2%Adrenal insufficiency
2%Atrial fibrillation
2%Sepsis
2%Malignant pleural effusion
2%Embolism
2%Cardiac failure
2%General physical health deterioration
1%Lung cancer metastatic
1%Neoplasm progression
1%Small intestinal haemorrhage
1%Gastrointestinal haemorrhage
1%Colitis
1%Appendicitis
1%Respiratory tract infection
1%Bone pain
1%Ataxia
1%Syncope
1%Bronchial obstruction
1%Pneumothorax
1%Circulatory collapse
1%Superior vena cava syndrome
1%Respiratory failure
1%Seizure
1%Pancytopenia
1%Atrial flutter
1%Pericardial effusion
1%Ileus
1%Small intestinal obstruction
1%Performance status decreased
1%Skin infection
1%Femur fracture
1%Hypercalcaemia
1%Cancer pain
1%Pericardial effusion malignant
1%Confusional state
1%Tumour pain
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the Investigator Choice of Chemotherapy ARM group. Side effects include: Nausea with 57%, Anaemia with 54%, Fatigue with 51%, Decreased appetite with 39%, Malignant neoplasm progression with 36%.

Trial Design

1 Treatment Group

Treatment (nivolumab, ipilimumab)
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

Treatment (nivolumab, ipilimumab)Experimental Group · 2 Interventions: Ipilimumab, Nivolumab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3260
Nivolumab
2014
Completed Phase 3
~4480

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Academic and Community Cancer Research UnitedLead Sponsor
50 Previous Clinical Trials
5,209 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,884 Total Patients Enrolled
1 Trials studying Stage IVB Hepatocellular Carcinoma
27 Patients Enrolled for Stage IVB Hepatocellular Carcinoma
Mehmet AkcePrincipal InvestigatorAcademic and Community Cancer Research United
2 Previous Clinical Trials
46 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 19 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your disease has spread beyond its original location and cannot be surgically removed.
References

Frequently Asked Questions

Has the FDA sanctioned Nivolumab for clinical use?

"Our team at Power has assigned nivolumab a score of 2 on the safety scale, due to the data collected during Phase 2 clinical trials that confirm its relative security but lack evidence for efficacy." - Anonymous Online Contributor

Unverified Answer

Is enrollment open for this research endeavor?

"Unfortunately, the trial listing on clinicaltrials.gov reveals that this medical study is no longer accepting participants; it was posted on November 30th of 2022 and last updated September 23rd. Nonetheless, there are still 2598 other trials beckoning for recruits at present time." - Anonymous Online Contributor

Unverified Answer

What is the geographic scope of this trial's management?

"There are 6 sites across the nation that currently have open slots for this medical trial. Examples include Emory University Hospital/Winship Cancer Institute in Atlanta, University of Miami Miller Schoolof Medicine-Sylvester Cancer Center in Miami, and Rutgers Cancer Institute of New Jersey in New Brunswick." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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