Table 1 Selected ongoing trials of ICI combined therapy for Solid cancer
From: Enhancing HCC Treatment: innovatively combining HDAC2 inhibitor with PD-1/PD-L1 inhibition
Condition or disease | Therapeutic regimen | Targets | Study | Phase | Total patient number | Recruitment Status | Primary Outcome Measures | Secondary Outcome Measures | Line of therapy |
|---|---|---|---|---|---|---|---|---|---|
Relapsed/Refractory Non-Hodgkin lymphoma; Advanced solid tumors | Chidamide (HDACi) + Immune checkpoint inhibitors (anti-PD1/PD-L1/CTLA4 antibodies) + Decitabine (DNA methyltransferase inhibiotr) | HDAC1,2,3,10 | NCT05320640 [87] | I/II | 100 (estimated enrollment) | Recruiting | ORR; AEs | DOR; PFS | Subsequent-line |
Cervical Cancer; Cervix Cancer; Cervix Neoplasm | Toripalimab (PD-1 inhibitor) + Chidamide (HDACi) | HDAC1,2,3,10 | NCT04651127 [62] | I/II | 40 (estimated enrollment) | Recruiting | Safety and tolerability; ORR | PFS; DOR; DCR; OS | Subsequent-line |
Sophageal squamous cell cancer; Adenocarcinoma of esophagogastric junction; Gastric adenocarcinoma; Unresectable, recurrent or metastatic disease | Chidamide (HDACi) + PD-1 inhibitor (Toripalimab) | HDAC1,2,3,10 | NCT05163483 [63] | II | 87 (estimated enrollment) | Recruiting | ORR | PFS; DOR; DCR; OS | Subsequent-line |
Solid tumors that are metastatic or cannot be removed by surgery or locally advanced or metastatic HER2-negative breast cancer | Entinostat (HDACi) + Nivolumab and/or Ipilimumab | Class I HDAC | NCT02453620 [88] | I | 57 | Recruiting | AEs | ORR PFS; DOR | Subsequent-line |
Advanced or metastatic non-small cell lung cancer with PD-L1 expression of ≥ 1% | HBI-8000 (HDACi) + Pembrolizumab | Class I HDAC | NCT05141357 [89] | II | 24 (estimated enrollment) | Active, not recruiting | ORR | DOR; DCR; PFS; Safety and tolerability | Subsequent-line (No prior treatment with checkpoint inhibitors or more than one regimen of chemotherapy including epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation directed therapy for advanced or metastatic disease) |
NSCLC; Melanoma; Mismatch-repair proficient colorectal cancer | Entinostat + Pembrolizumab | Class I HDAC | NCT02437136 [90] | I/II | 202 | Recruiting | Safety and Tolerability; AEs; ORR | CBR; PFS; OS; DOR; TTR | Subsequent-line |
Children and adolescents with high risk refractory/relapsed/progressive tumors (CNS Tumor , Solid Tumor) | Entinostat + Nivolumab | Class I HDAC | NCT03838042 [91] | I/II | 128 (estimated enrollment) | Recruiting | DLT; Best response (CR or PR) | DOR; DCR; SD; PFS, etc. | Subsequent-line |