Study to evaluate the effectiveness, safety and tolerability of nivolumab in subjects with advanced liver cancer.

Phase 1

• Conditions: Hepatocellular carcinoma; MedDRA version: 19.1Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentSystem Organ Class: 100000004864; MedDRA version: 19.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864; MedDRA version: 19.1Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001514-42-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Last Update Posted: 13 February 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 570

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. 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 342
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 228
;
-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. 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 342
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 228
;
-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. 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 342
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 228

Exclusion Criteria

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

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

;
-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