A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First … (NCT05199285) | Clinical Trial Compass
TerminatedPhase 2
A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab
Stopped: Sponsor has withdrawn support for the study.
United States15 participantsStarted 2023-01-19
Plain-language summary
This phase II trial tests whether nivolumab and ipilimumab works to shrink tumors in patients with liver cancer that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab and ipilimumab may be effective in killing tumor cells in patients with liver cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>= 18 years.
* HCC diagnosis confirmed by histology/cytology or clinically by American Association for Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* Locally advanced, metastatic, or unresectable disease.
* Child Pugh class A.
* Barcelona clinic liver cancer (BCLC) stage B (not amenable to liver directed therapy) or stage C.
* Prior treatment with atezolizumab and bevacizumab combination with radiographic progression that necessitates change in treatment per treating physician. Patients with rapid progression on atezolizumab and bevacizumab (defined as patients who progressed radiographically in the first restaging scan that necessitates change in treatment) are excluded.
* Washout period \>= 4 weeks prior to registration is required since last atezolizumab and bevacizumab dose.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. (Form is available on the Academic and Community Cancer Research United \[ACCRU\] website).
* Absolute neutrophil count (ANC) \>= 1000/mm \^ 3 (obtained =\< 28 days prior to registration).
* Platelet count \>= 60,000/mm\^3 (obtained =\< 28 days prior to registration).
* Hemoglobin \>= 8.5 g/dL (obtained =\< 28 days prior to registration).
* Total bilirubin =\< 3 x upper limit of normal (ULN) (obtained =\< 28 days prior to registration).
* Alanine aminotransferase (ALT) and aspar…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Confirmed objective response rate (ORR)
Timeframe: Up to 6 months
Trial details
NCT IDNCT05199285
SponsorAcademic and Community Cancer Research United