Phase 2
N=21
A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC)
Carcinoma, Hepatocellular
Bottom Line
View on ClinicalTrials.gov: NCT02859324 ↗Enrolled (actual)
21
Serious AEs
71.4%
Results posted
May 2021
Primary outcome: Primary: Incidence of Dose Limiting Toxicities (DLTs) — 1; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CC-122 (Drug); Nivolumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Dose Limiting Toxicities (DLTs) |
1; 1; 2 | — |
| PRIMARY Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) |
7; 9; 5; 7; 6; 4 | — |
| PRIMARY Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
42.9; 0; 0 | — |
| SECONDARY Disease Control Rate (DCR) by RECIST 1.1 |
71.4; 44.4; 80.0 | — |
| SECONDARY Duration of Response (DoR) by RECIST 1.1 |
NA; NA; NA | — |
| SECONDARY Progression-Free Survival (PFS) by RECIST 1.1 |
130.0; 95.0; 122.0 | — |
| SECONDARY Overall Survival (OS) by RECIST 1.1 |
320.0; 303.0; 135.0 | — |
| SECONDARY Time to Progression (TTP) by RECIST 1.1 |
NA; 95.0; 166.0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) |
56.3; 81.0; 82.6 | — |
| SECONDARY Area Under the Concentration Time Curve (AUC) |
235.3; 399.8; 257.9 | — |
| SECONDARY Time to Maximum Concentration (Tmax) |
0.5; 1.0; 1.0 | — |
| SECONDARY Terminal Half-life (T-HALF) |
8.4; 6.4 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
40.1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02859324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.