Table 4.
Ongoing Clinical Trials Investigating Novel Combination Treatment Regimens for HCC
| Trial Name | Phase | Target Population | Treatment Arms | Primary Endpoint | Secondary Endpoint | Estimated Study Completion Date |
|---|---|---|---|---|---|---|
| CheckMate 040 (NCT01658878) | I/II | Untreated, advanced HCC | Nivolumab | Safety & tolerability, ORR | Complete response rate, disease control rate, duration of response, time to response, time to progression, PFS, OS, PD-L1 expression, pharmacokinetics of Nivolumab | April 2022 |
| Nivolumab + Ipilimumab | ||||||
| Nivolumab + Cabozantinib | ||||||
| Nivolumab + Ipilimumab + Cabozantinib | ||||||
| Sorafenib | ||||||
| NCT03299946 | I | Locally advanced HCC | Cabozantinib + Nivolumab | Number of AE, number of patients who complete pre-op treatment and proceed to surgery | % of patients who obtain R0 resection, % of patients with complete response, % of patients with major pathologic responses, ORR, OS, disease-free survival | March 2022 |
| COSMIC-312 (NCT03755791) | III | Advanced HCC without previous systemic therapy | Cabozantinib + Atezolizumab (experimental) | PFS (experimental vs control), OS | PFS (single-agent vs control) | December 2021 |
| Sorafenib (control) | ||||||
| Cabozantinib (single-agent) | ||||||
| CLEARANCE (NCT03963206) | IV | Intermediate HCC (ineligible for chemoembolization), or advanced HCC (after failure of Sorafenib or another systemic therapy) | Cabozantinib (20, 40, or 60 mg) | OS | AE, daily median dose of cabozantinib, number of patients with each dose of cabozantinib | September 2021 |
| NCT03586973 | II | Advanced HCC in Japanese patients | Cabozantinib (post first-line progression on sorafenib) | 24-week PFS rate | PFS, ORR, disease-control rate, OS | November 2020 |
| Cabozantinib (treatment-naïve) |