Safety and Bioactivity of Ipilimumab and Nivolumab Combination Prior to Liver Resection in Hepatocellular Carcinoma
NCT ID: NCT03682276
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2019-03-01
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients with early-stage HCC will first undergo screening procedures during a 28-day time window between giving consent and starting drug treatment. Screening procedures will include:
* Medical interview and physical exam
* ECG
* Tumour biopsy
* Tumour imaging by MRI
* Tumour imaging by CT
* Blood and urine samples
* Stool sample (optional)
Patients meeting the protocol-specified criteria will be enrolled and on Day 1 will have the following:
* Medical interview, and physical exam (if required)
* Blood and urine samples
* Intravenous dose of ipilimumab ('YERVOY') 1 milligram per kilogram body weight
* Intravenous dose of nivolumab ('OPDIVO') 3 milligrams per kilogram body weight
On Day 22 the participants will have the following:
* Medical interview, and physical exam (if required)
* Blood and urine samples
* Intravenous dose of nivolumab ('OPDIVO') 3 milligrams per kilogram body weight
On Day 43 the participants will have the following:
* Medical interview, and physical exam (if required)
* ECG
* Tumour imaging by MRI
* Blood and urine samples
* Stool sample (optional)
Patients who remain eligible for liver resection will likely undergo surgery within a few days of the Day 43 visit.
On Day 127 the participants will have the following:
* Medical interview, and physical exam (if required)
* Tumour imaging by MRI
* Blood and urine samples
Every 4 months thereafter until 2 years later, or until starting another anti-cancer treatment, participants will have tumour imaging by MRI.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Group
Ipilimumab, solution for infusion, 1 milligram per kilogram body weight, once every 3 weeks, for 3 weeks; Nivolumab, solution for infusion, 3 milligrams per kilogram body weight, once every 3 weeks, for 6 weeks
Ipilimumab
Ipilimumab is a monoclonal antibody given as an immunotherapy
Nivolumab
Nivolumab is a monoclonal antibody given as an immunotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ipilimumab
Ipilimumab is a monoclonal antibody given as an immunotherapy
Nivolumab
Nivolumab is a monoclonal antibody given as an immunotherapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Aged ≥18 years
3. Confirmed diagnosis of HCC
4. Willing to provide tissue from an excisional biopsy of a tumour lesion
5. Have measurable disease by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI) defined by RECIST 1.1 criteria
6. Ineligible for liver transplantation
7. Medically fit to undergo surgery as determined by the treating medical and surgical oncology team
8. ECOG performance status 0 or 1
9. Adequate organ function
10. Overall Child-Pugh class A
11. Female patient of childbearing potential should have a negative serum pregnancy test within 24 h of her first dose of IMP
12. Women of childbearing potential must be willing to use a highly effective method of contraception for the course of the study through 5 months after the last dose of Investigational Medicinal Product (IMP). Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
13. Sexually active males must agree to use an adequate method of contraception starting with the first dose of IMP through 7 months after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
Exclusion Criteria
2. Prior systemic anticancer treatment for HCC, including an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody
3. Prior orthotopic liver transplantation
4. Any major surgery within the 3 weeks prior to enrolment
5. Hepatic encephalopathy
6. Ascites that is refractory to diuretic therapy
7. Is currently receiving anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy or biologic therapy) or has participated or is participating in a study of an IMP or used an investigational device within 4 weeks of the first dose of IMP
8. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy
9. Known history of active Bacillus Tuberculosis (TB)
10. History of known hypersensitivity to any monoclonal antibody or any of their excipients
11. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer
12. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
13. Known history of, or any evidence of active, non-infectious pneumonitis
14. Active infection requiring systemic therapy, with exceptions relating to Hepatitis B and C virus infection
15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Principal Investigator (PI)
16. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
17. Pregnant or breastfeeding
18. Known history of Human Immunodeficiency Virus (HIV; HIV 1/2 antibodies)
19. Received a live vaccine within 30 days of first dose of IMP administration. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David J Pinato
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Imperial College Healthcare NHS Trust
London, Greater London, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Rohini Sharma, MD
Role: primary
Frances Abomeli
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Pinato DJ, Cortellini A, Sukumaran A, Cole T, Pai M, Habib N, Spalding D, Sodergren MH, Martinez M, Dhillon T, Tait P, Thomas R, Ward C, Kocher H, Yip V, Slater S, Sharma R. PRIME-HCC: phase Ib study of neoadjuvant ipilimumab and nivolumab prior to liver resection for hepatocellular carcinoma. BMC Cancer. 2021 Mar 23;21(1):301. doi: 10.1186/s12885-021-08033-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-000987-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-9LC
Identifier Type: OTHER
Identifier Source: secondary_id
C/36/2017
Identifier Type: -
Identifier Source: org_study_id