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

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Hepatocellular

In brief

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.

Key facts

Study ID

NCT02859324

Run by

Celgene

People needed

21

Starts

2016-09-20

Expected to finish

2020-03-27

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Division of Hematology Oncology — Los Angeles, California, United States
• University of Florida — Gainesville, Florida, United States
• NYU Langone Medical Center — New York, New York, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• Institut Paoli Calmettes — Marseille, France
• Centre Eugene Marquis — Rennes, France
• Institut Universitaire du Cancer IUCT - Oncopole — Toulouse, France
• Institut Gustave Roussy Hematologie — Villejuif, France
• IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center — Milan, Italy
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
• Istituto Nazionale Tumori Regina Elena — Roma, Italy
• Hospital Universitario Vall D Hebron — Barcelona, Spain
• Hospital Ramon y Cajal — Madrid, Spain
• Hospital 12 de Octubre — Madrid, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.