Protocol No.: OCR15272
Sponsor Protocol No.: CC-122-HCC-002
A phase 1/2, multicenter, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-122 in combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC)
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.
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.
Phase: Phase I/II
Age Group: Adult
CC-122 with Nivolumab:
CC-122 orally 5/7 days with nivolumab Intravenously (IV) 3mg/kg every 2 weeks. Cohorts of up to 6 subjects per dose level until Recommended Phase 2 dose (RP2D).
1. Ages 18 years old and older
2. Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) Guidelines.
3. 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.
4. Subject has at least one measurable lesion according to RECIST 1.1.
5. Subject has a life expectancy of ≥ 12 weeks
6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
9. Subject has adequate hematologic function and adequate hepatic function at screening
1. The presence of any of the following will exclude a subject from enrollment:
2. Subject has received more than 2 previous systemic therapies for Hepatocellular carcinoma (HCC).
3. Subject has received previous treatment with any anti-PD-1 (Programmed death 1) or anti-PD-L1 (PD-1 ligand receptor) antibody
Applicable Disease Sites
UF Gainesville : Twanda Robinson
Twanda Robinson, RN
Phone: +1 352-273-9489