TABLE 2.
Ongoing Clinical Trials of Dual Immune Checkpoint Inhibition in Patients With Liver Cancer
| Intervention | Target | Trial Type | Trial Description | ClinicalTrials.gov Identifier |
|---|---|---|---|---|
| Dual immune checkpoint inhibition | ||||
| HCC | ||||
| Nivolumab + ipilimumab | PD-1; CTLA-4 | Phase 3, randomized, multicenter | Advanced, treatment-naïve HCC; Child-Pugh score 5 or 6 (1,084 pts) | NCT04039607 |
| Phase 1/2, randomized, open label | Advanced HCC; Child-Pugh B (1,097 pts) | NCT01658878 | ||
| Durvalumab + tremelimumab | PD-L1; CTLA-4 | Phase 3, randomized, open label, multicenter | Treatment-naïve, unresectable HCC; BCLC stage B/C (1,310 pts) | NCT03298451 |
| Phase 2, randomized, open label, multicenter | Advanced HCC (433 pts) | NCT02519348 | ||
| Phase 2, two arms, open label | Intermediate-stage HCC (30 pts) | NCT03638141 | ||
| Nivolumab + relatlimab | PD-1; LAG-3 | Phase 1/2a, randomized, open label | Advanced, treatment-naïve solid tumors including HCC (1,500 pts) | NCT01968109 |
| TSR-042 + TSR-022 | PD-1; TIM-3 | Phase 2, single arm, open label | Advanced or metastatic HCC; BCLC stage B/C (42 pts) | NCT03680508 |
| CCA | ||||
| Nivolumab + ipilimumab | PD-L1; CTLA-4 | Phase 2, single arm, open label | Advanced, refractory solid tumors including BTC (707 pts) | NCT02834013 |
| Phase 2, randomized, open label | Unresectable, treatment-naïve BTC; Child-Pugh A (64 pts) | NCT03101566 | ||
| Durvalumab + tremelimumab | PD-L1; CTLA-4 | Phase 1, nonrandomized, open label | Advanced, refractory, biopsiable solid tumors including BTC (269 pts) | NCT01938612 |
Note: A www.ClinicalTrials.gov search was performed using the terms “liver cancer,” “hepatocellular carcinoma,” “liver neoplasm” for HCC; “biliary tract cancer,” “cholangiocarcinoma,” “biliary carcinoma,” “bile duct,” or “biliary tract” for CCA; and “hepatobiliary malignant tumors” for both HCC and CCA. The search identified immunotherapy trials with a status of “Recruiting,” “Not yet recruiting,” “Active, not recruiting,” or “Enrolling by invitation,” and trials without the inclusion of a specific liver cancer cohort or without adequate information available were excluded. Search was updated as of March 30, 2020.
Abbreviations: LAG-3, lymphocyte-activation gene 3; TIM-3, T-cell immunoglobulin mucin-3.