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A Phase 3 Study of Nivolumab versus Placebo for Participants with Hepatocellular Cancer Who Are at High Risk of Recurrence after Hepatic Resection or Ablation
EU CTIS ID: 2023-508726-10-00
What this study is testing
To compare recurrence-free survival (RFS) (based on BICR assessment) of nivolumab vs placebo in all randomized participants.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males and females, ages 18 or older.
- Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation.
- Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC.
- Participants are eligible to enroll if they have undergone: i) Hepatic resection and have the following tumor characteristics: up to three tumors, at least one with a diameter > 5 cm OR none with a diameter > 5 cm but with confirmation of microvascular invasion or poorly /undifferentiated HCC; or more than three tumors, none with a diameter > 5 cm ii) Local ablation [radiofrequency ablation (RFA) or microwave ablation (MWA)] and have the following tumor characteristics: solitary tumor > 3cm but <=5 cm; OR Multiple tumors (up to 4), none with a diameter > 5 cm
- Participants must have complete resection response, or must have achieved radiologically documented complete resection after local ablation.
- All participants are required to have imaging studies confirming disease-free status at least 4 weeks after either complete tumor removal after surgical resection or local ablation, and within 4 weeks prior to randomization.
You likely can't join if
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- Participants previously receiving any prior therapy for HCC, including loco-regional therapies, before or after resection or ablation.
- Participants receiving or expected to receive IFN-based therapies during the study period.
- Positive pregnancy test.
- Prior recurrence of HCC.
See the full eligibility criteria
- Males and females, ages 18 or older.
- Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation.
- Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC.
- Participants are eligible to enroll if they have undergone: i) Hepatic resection and have the following tumor characteristics: up to three tumors, at least one with a diameter > 5 cm OR none with a diameter > 5 cm but with confirmation of microvascular invasion or poorly /undifferentiated HCC; or more than three tumors, none with a diameter > 5 cm ii) Local ablation [radiofrequency ablation (RFA) or microwave ablation (MWA)] and have the following tumor characteristics: solitary tumor > 3cm but <=5 cm; OR Multiple tumors (up to 4), none with a diameter > 5 cm
- Participants must have complete resection response, or must have achieved radiologically documented complete resection after local ablation.
- All participants are required to have imaging studies confirming disease-free status at least 4 weeks after either complete tumor removal after surgical resection or local ablation, and within 4 weeks prior to randomization.
- Child-Pugh Score 5 or 6.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- Participants previously receiving any prior therapy for HCC, including loco-regional therapies, before or after resection or ablation.
- Participants receiving or expected to receive IFN-based therapies during the study period.
- Positive pregnancy test.
- Prior recurrence of HCC.
- Any evidence of tumor metastasis or co-existing malignant disease.
- Participants showing evidence of macrovascular invasion on imaging tests.
- Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation.
- Active co-infection with both Hepatitis B and C, OR Hepatitis D and B.
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Participants with an active, known or suspected autoimmune disease.
- Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Russian Federation
- Taiwan
- United States
- Hong Kong
- Japan
- Korea, Republic of
- Argentina
- Canada
- United Kingdom
- Mexico
- Singapore
- China
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Russian Federation; Taiwan; United States; Hong Kong; Japan and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.