Table 4.
Examples of clinical trials combining immunotherapies and epigenetic regulators.
| Drug | Target(s) | Cancer Type | Phase | Status and Enrolment | NCT Number |
|---|---|---|---|---|---|
| Azacitidine Pembrolizumab Epacadostat |
DNMT PD-1 IDO1 |
Solid Tumor Advanced Malignancies Metastatic Melanoma |
Phase 1/2 | Completed (March 2020) 70 |
NCT02959437 |
| Azacitidine Pembrolizumab |
DNMT PD-1 |
Refractory Acute Myeloid Leukemia (AML) | Phase 2 | Recruiting 40 |
NCT02845297 |
| Azacitidine Entinostat Nivolumab |
DNMT HDAC PD-1 |
Non-Small Lung Cancer | Phase 2 | Recruiting 120 | NCT01928576 |
| Azacitidine Durvalumab | DNMT PD-L1 |
Head and Neck Cancer | Phase 1/2 | Recruiting 59 | NCT03019003 |
| Azacitidine Durvalumab | DNMT PD-L1 |
Microsatellite Stable Colorectal Carcinoma Platinum Resistant Epithelial Ovarian Cancer Type II Estrogen Receptor Positive and HER2 Negative Breast Cancer |
Phase 2 | Recruiting 28 | NCT02811497 |
| Azacitidine Avelumab |
DNMT PD-L1 |
Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia |
Phase ½ | Recruiting 138 | NCT03390296 |
| Azacitidine Durvalumab Romidepsin | DNMT1 PD-L1 HDAC |
Lymphoma, T-Cell | Phase ½ | Recruiting 148 | NCT03161223 |
| Azacitidine Nivolumab INCB059872 | DNMT1 PD-1 LSD1 |
Solid Tumors Hematologic Malignancy (SCLC) |
Phase ½ | Recruiting 215 | NCT02712905 |
| Guadecitabine Atezolizumab | DNMT PD-L1 |
Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome Recurrent Acute Myeloid Leukemia with Myelodysplasia-Related Changes |
Phase ½ | Recruiting 72 | NCT02935361 |
| Guadecitabine Durvalumab | DNMT PD-L1 |
Advanced Kidney Cancer Kidney Cancer Clear Cell Renal Cell Carcinoma |
Phase ½ | Recruiting 48 | NCT03308396 |
| Guadecitabine Mocetinostat Pembrolizumab |
DNMT HDAC PD-1 |
Lung Cancer | Phase 1 | Recruiting 40 | NCT03220477 |
| Anti-PD-1 antibody alone or in combination with decitabine | DNMT PD-1 |
Multiple Malignancies | Phase ½ | Recruiting 250 | NCT02961101 |
| Abexinostat Pembrolizumab | HDAC PD-1 |
Stage III Cutaneous Melanoma, Stage IV Cutaneous Melanoma, Locally Advanced Melanoma Locally Advanced Solid Neoplasm |
Phase 1 | Recruiting 42 | NCT03590054 |
| Entinostat Pembrolizumab |
HDAC PD-1 |
Melanoma | Phase 2 | Recruiting 14 | NCT03765229 |
| Domatinostat Avelumab | HDAC PD-L1 |
Gastrointestinal Cancer | Phase 2 | Recruiting 75 | NCT03812796 |
| Entinostat Pembrolizumab | HDAC PD-1 |
Myelodysplastic Syndrome | Phase 1 | Recruiting 27 | NCT02936752 |
| Vorinostat Pembrolizumab | HDAC PD-1 |
Renal Cell Carcinoma Urinary Bladder Neoplasms |
Phase 1 | Active, not recruiting 57 | NCT02619253 |
| Entinostat Ipilimumab Nivolumab |
HDAC CTLA-4 |
Breast Adenocarcinoma Invasive Breast Carcinoma Metastatic Breast Carcinoma Metastatic Malignant Solid Neoplasm |
Phase 1 | Active, not recruiting 45 | NCT02453620 |
| Romidepsin Pembrolizumab | HDAC PD-1 |
Colorectal Cancer | Phase 1 | Active, not recruiting 27 | NCT02512172 |
| Atezolizumab Bevacizumab Entinostat | PD-L1 VEGF HDAC |
Advanced Renal Cell Carcinoma | Phase 1/2 | Recruiting 62 | NCT03024437 |
| CPI-1205 Ipilimumab |
EZH2 CTLA-4 |
Advanced Solid Tumors | Phase 1/2 | Not recruiting 24 |
NCT03525795 |
| Tazemetostat Pembrolizumab | EZH2 PD-1 |
Locally Advanced Urothelial Carcinoma Metastatic Urothelial Carcinoma |
Phase 1/2 | Recruiting 30 | NCT03854474 |
| Tazemetostat Atezolizumab Obinutuzumab | EZH2 PD-L1 |
Lymphoma | Phase 1 | Completed 96 | NCT02220842 |
| BMS: 986158 Nivolumab |
BET PD-1 |
Advanced tumors | Phase 1/2 | Recruiting 417 |
NCT02419417 |
| RO6870810 Daratumumab |
BET CD38 |
Advanced multiple myeloma | Phase 1 | Completed 86 | NCT03068351 |
BET = bromodomain and extra-terminal domain proteins, EZH2 = enhancer of zeste homolog 2, IDO1 = indoleamine 2,3-dioxygenase 1, LSD1 = lysine-specific demethylase 1, VEGF = vascular endothelial growth factor.