A Phase 3 Study of Nivolumab versus Placebo for Participants withHepatocellular Cancer Who Are at High Risk of Recurrence after HepaticResection or Ablatio

Phase 1

Conditions: Hepatocellular carcinoma
MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-002755-29-IT

Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 883

Inclusion Criteria

1. Males and females, ages 18 or older.
2. Participants must have a first diagnosis of HCC amenable for
management with curative intent by resection or local ablation.
3. Participants are eligible to enroll if they have non-viral related-HCC, or
if they have HBV-HCC, or HCV-HCC
4. 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
5. Participants must have complete resection response, or must have
achieved radiologically documented complete resection after local ablation.
6. 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.
7. Child-Pugh Score 5 or 6
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 441
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 442

Exclusion Criteria

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed
cholangiocarcinoma and HCC.
2. Prior recurrence of HCC.
3. Any evidence of tumor metastasis or co-existing malignant disease.
4. Participants showing evidence of macrovascular invasion on imaging
tests.
5. Participants who have undergone a liver transplant or those who are
in the waiting list for liver transplantation.
6. Active co-infection with with both Hepatitis B and C, OR Hepatitis D
and B
7. Known history of positive test for human immunodeficiency virus
(HIV) or known acquired immunodeficiency syndrome (AIDS).
8. Participants with an active, known or suspected autoimmune disease.
9. Participants with a condition requiring systemic treatment with either
corticosteroids or other immunosuppressive medications within 14 days
of start of study treatment.
10. Prior malignancy active within the previous 3 years except for locally
curable cancers that have been apparently cured.
11. Participants previously receiving any prior therapy for HCC, including
loco-regional therapies, before or after resection or ablation.
12. Participants receiving or expected to receive IFN-based therapies
during the study period.
13. Positive pregnancy test.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare recurrence-free survival (RFS) (based on BICR assessment) of nivolumab vs placebo in all randomized participants;Secondary Objective: To compare overall survival (OS) of nivolumab vs placebo in all<br>randomized participants.<br>¿ To evaluate time to recurrence (TTR) (based on BICR assessment) of<br>nivolumab vs placebo in all randomized participants.;Primary end point(s): Recurrence free survival (RFS), defined as the time from<br>randomization to the first documented disease recurrence or death (by any cause), whichever occurs first;Timepoint(s) of evaluation of this end point: RFS will be evaluated on an ongoing basis from randomization until recurrence

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ¿ OS, defined as the time between the date of randomization and the<br>date of death (by any cause).<br>¿ Time to Recurrence (TTR), defined as the time from randomization to the first documented disease recurrence;Timepoint(s) of evaluation of this end point: OS: From the beginning of randomization period up to date of event<br>TTR: time from randomization to the first documented disease recurrence

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