A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC)

• Status: Completed
• Trial end date: 2020-03-27
• Target enrollment: 0
• Participant gender: All

Summary

CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

Inclusion Criteria:

• Subjects must satisfy the following criteria to be enrolled in the study:

• Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)

• Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) Guidelines.

• Subjects who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.

• Subject has at least one measurable lesion according to RECIST 1.1.

• Subject has a life expectancy of ≥ 12 weeks

• Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

• Subject has adequate hematologic function and adequate hepatic function at screening

Exclusion Criteria:

• The presence of any of the following will exclude a subject from enrollment:

• Subject has received more than 2 previous systemic therapies for Hepatocellular carcinoma (HCC).

• Subject has received previous treatment with any anti-PD-1 (Programmed death 1) or anti-PD-L1 (PD-1 ligand receptor) antibody