Last updated on May 2017

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 naïve 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

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UCLA Hematology Oncology
Santa Monica, CA United States
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University of Florida
Gainesville, FL United States
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NYU Langone Medical Center
New York, NY United States
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Mary Crowley Medical Research Center
Dallas, TX United States
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Institut Paoli Calmettes
Marseille Cedex 9, France
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Institut Universitaire du Cancer IUCT - Oncopole
Toulouse Cedex, France
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IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
Milan, Italy
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Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
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Istituto Nazionale Tumori Regina Elena
Roma, Italy
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Hospital Universitario Vall D`Hebron
Barcelona, Spain
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