Last updated on September 2018

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


Brief description of study

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 nave to systemic therapy.

Detailed Study Description

Subjects will have received either none or no more than 2 previous systemic therapies. The dose escalation part of the study will explore 1 or more dose levels of CC-122 in combination with nivolumab using a modified dose escalation (3+3) design, followed by an expansion part once the recommended Phase 2 dose (RP2D) is defined.

A modified 3+3 dose escalation design will be used to identify the initial toxicity of the combination. Up to six subjects will be concurrently enrolled into a dose level. Decisions as to which dose level to enroll a new subject will be based on the number of subjects enrolled and evaluable, the number of subjects experiencing DLTs, and the number of subjects enrolled but who are not yet evaluable for toxicity in the current cohort at the time of new subject entry.

Clinical Study Identifier: NCT02859324

Contact Investigators or Research Sites near you

Start Over

Associate Director Clinical Trial Disclosure

University of Florida
Gainesville, FL United States

Associate Director Clinical Trial Disclosure

NYU Langone Medical Center
New York, NY United States

Associate Director Clinical Trial Disclosure

Institut Paoli Calmettes
Marseille Cedex 9, France

Associate Director Clinical Trial Disclosure

Centre Eugene Marquis
Rennes, France

Associate Director Clinical Trial Disclosure

Institut Universitaire du Cancer IUCT - Oncopole
Toulouse Cedex, France

Associate Director Clinical Trial Disclosure

Institut G. Roussy
Villejuif, France

Associate Director Clinical Trial Disclosure

IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
Milan, Italy

Associate Director Clinical Trial Disclosure

Fondazione IRCCS Policlinico San Matteo
Pavia, Italy

Associate Director Clinical Trial Disclosure

Istituto Nazionale Tumori Regina Elena
Roma, Italy

Associate Director Clinical Trial Disclosure

Hospital Ramon y Cajal
Madrid, Spain

Associate Director Clinical Trial Disclosure

Hospital 12 de Octubre
Madrid, Spain

Associate Director Clinical Trial Disclosure

Mary Crowley Cancer Research
Dallas, TX United States

Associate Director Clinical Trial Disclosure

UCLA Division of Hematology Oncology
Los Angeles, CA United States

Associate Director Clinical Trial Disclosure

Hospital Universitario Vall D Hebron
Barcelona, Spain