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A Phase I Dose Escalation 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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

A Phase I Dose Escalation 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


Study Classification: Pharmacokinetics/Pharmacodynamics


Inclusion Criteria:



- Subjects with histological confirmation of advanced hepatocellular carcinoma;
subjects must have progressive disease following or be intolerant of at least one
line of therapy or refuse sorafenib treatment; subjects must be off sorafenib
treatment for at least 28 days prior to first dose

- Child-Pugh score of A

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

Exclusion Criteria:

- Subjects with brain metastasis

- Encephalopathy

- Any prior or current ascites requiring paracentesis for control; any history of
clinically meaningful variceal bleeding within the last three months

- Active coinfection with both hepatitis B and C

- Hepatitis D infection in subjects with hepatitis B

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of worst adverse events

Outcome Description:

All non-serious adverse events will be collected from Day 1 until 100 days after the subject's last dose of BMS-936558

Outcome Time Frame:

Up to 100 days after the last dose of BMS-936558

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA209-040

NCT ID:

NCT01658878

Start Date:

October 2012

Completion Date:

May 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

University of Michigan Ann Arbor, Michigan  48109-0624
Providence Portland Medical Center Portland, Oregon  97213-3635
USC Norris Comprehensive Cancer Center Los Angeles, California  90089