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

Study population included subjects who had progressed after or were intolerant to no more

than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic

therapy.

The dose escalation part of the study was designed to explore three dose levels of CC-122

to identify the recommended phase 2 dose (RP2D) to be used in the expansion phase.

Approximately 20 subjects were to be enrolled in the dose escalation part of the study.

Subjects could be treated for up to 2 years, or until progression of disease,

unacceptable toxicity, subject/physician decision, withdrawal of consent, death. Safety

follow up until 28 days after CC122 treatment and 90 days after nivolumab treatment.

RECIST 1.1 criteria was used to determine response. Survival follow up until death,

withdrawal of consent, or the study closes. Subjects were permitted to continue treatment

beyond progression (TBP) if they continue to meet protocol criteria, had stable

performance status, had clinical benefit, other treatment options were discussed. A

separate ICF was signed to continue TBP.

During the dose escalation phase, CC-122 was administered orally 5 consecutive days out

of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each

28-day cycle. Once the RP2D for dosing of CC-122 in combination with nivolumab was

defined, expansion (Phase 2) would start. A modified 3+3 dose escalation design was used

to identify the initial toxicity of the combination. Up to six subjects were concurrently

enrolled into a dose level. Decisions as to which dose level to enroll a new subject were

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. A Safety Review

Committee (SRC) comprised of investigators participating in the study made dose

escalation decisions based on these criteria.

After completion of the Dose Escalation Phase, the Dose Expansion Phase of the study did

not proceed due to the changing landscape in the treatment of HCC. There were no

additional safety concerns or safety signals identified in the dose escalation phase of

the study.