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Clinical Trials/EUCTR2012-001514-42-GB
EUCTR2012-001514-42-GB
Active, not recruiting
Phase 1

A Phase I-II Dose Escalation and Expansion Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Advanced Hepatocellular Carcinoma in Subjects with or without Chronic Viral Hepatitis - Anti-PD-1 HCC

Bristol-Myers Squibb International Corporation0 sites570 target enrollmentDecember 30, 2014
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ConditionsHepatocellular carcinomaMedDRA version: 20.0 Level: LLT Classification code 10019829 Term: Hepatocellular carcinoma recurrent System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10019830 Term: Hepatocellular carcinoma resectable System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOpdivo (100 mg/10 ml)Nexavar 200 mg film-coated tablets

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hepatocellular carcinoma
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
570
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 30, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Not specified

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