Study to evaluate the effectiveness, safety and tolerability of nivolumaband the combination nivolumab plus other agents in subjects withadvanced liver cancer.

Phase 1

• Conditions: Hepatocellular carcinoma; MedDRA version: 21.0Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001514-42-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

-Subjects of 18 years or older (men and women) with histologically
confirmed advanced hepatocellular carcinoma, not eligible for surgical
and/or locoregional therapies; or progressive disease after surgical and
/or locoregional therapies
-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
1
-Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5:
Child-Pugh Class B (B7 to B8). For all other cohorts Child-Pugh score of 6
points or less
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 372
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 248

Exclusion Criteria

-History of autoimmune disease
-Any prior or current clinically significant ascites

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified