Table 2 |.
Trials targeting genomic correlates of response to immune checkpoint blockade
| Intervention | Trial number | Patient population | Phase | Setting | Status |
|---|---|---|---|---|---|
| Neoantigen vaccines | |||||
| NeoVax + anti-CTLA-4 ipilimumab | NCT02950766 | Stage III or low-volume stage IV RCC | I | Adjuvant/1st line | Not yet recruiting |
| NeoVax + anti-PD-1 nivolumab ± anti-CTLA-4 ipilimumab | NCT03422094 | Newly diagnosed, unmethylated glioblastoma | I | 1st line | Recruiting |
| NeoVax + ant-CD20 rituxumab | NCT03361852 | Follicular lymphoma | I | 1st line | Not yet recruiting |
| NeoVax + alkylating agent cyclophosphamide | NCT03219450 | Chronic lymphocytic leukemia | I | 1st line | Not yet recruiting |
| Interferon therapies | |||||
| Interferon-γ-1β + anti-PD-1 pembrolizumab | NCT03063632 | Mycosis fungoides and Sézary syndrome | II | Refractory | Recruiting |
| Interferon-γ + anti-PD-1 nivolumab | NCT02614456 | Advanced solid tumors | I | 2nd line | Recruiting |
| JAK1 inhibitor itacitinib or PI3Kδ inhibitor + anti-PD-1 pembrolizumab | NCT02646748 | Advanced solid tumors | I/II | Refractory | Recruiting |
| JAK2 inhibitor ruxolitinib + anti-PD-1 pembrolizumab | NCT03012230 | Metastatic triple-negative breast cancer | I | 2nd line | Recruiting |
| JAK1 inhibitor itacitinib + anti-PD-1 pembrolizumab | NCT03425006 | Metastatic PD-L1+ NSCLC | II | 1st line | Recruiting |
| STING agonist MIW815 + anti-PD-1 spartalizumab | NCT03172936 | Advanced solid tumors or lymphomas | I | Any line | Recruiting |
| CDK4/6 inhibitors | |||||
| Fulvestrant ± CDK4/6 inhibitor palbociclib ± anti-PD-L1 avelumab | NCT03147287 | Metastatic HR+HER2− breast cancer | II | 2nd-3rd line | Recruiting |
| Tamoxifen ± CDK4/6 inhibitor palbociclib followed by anti-PD-LI avelumab | NCT03573648 | Stage II or III HR+ breast cancer | II | Neoadjuvant | Recruiting |
| CDK4/6 inhibitor ribociclib + anti-PD-1 spartalizumab (+ fulvestrant if breast) | NCT03294694 | Metastatic ovarian cancer or HR+HER2− breast cancer | I | Any line | Recruiting |
| CDK4/6 inhibitor abemaciclib + anti-PD-1 pembrolizumab | NCT02779751 | Metastatic NSCLC or HR+HER2− breast cancer | I | 1st-3rd line | Recruiting |
| Anti-PD-L1 avelumab, cetuximab, + CDK4/6 inhibitor palbociclib | NCT03498378 | Recurrent/metastatic headand neck squamous cell carcinoma | I | Any line | Recruiting |
| Anti-TGF-β therapies | |||||
| Anti-TGF-β NIS793 + anti-PD-1 spartalizumab | NCT02947165 | Advanced solid tumors | I | Refractory | Recruiting |
| TGF-β receptor 1 inhibitor galunisertib + anti-PD-LI durvalumab | NCT02734160 | Metastatic pancreatic cancer | I | 3rd line | Recruiting |
| TGF-β receptor 1 inhibitor galunisertib + ant-PD-1 nivolumab | NCT02423343 | HCC or recurrent NSCLC | I/II | 2nd line | Recruiting |
| Anti-PD-L1/TGF-β trap M7824 | NCT02517398 | Metastatic or locally advanced solid tumors | I | Refractory | Recruiting |
| Anti-PD-LI/TGF-β trap M7824 + treatment of physician’s choice | NCT03620201 | Stage II-III HER2+ breast cancer | I | Neoadjuvant | Recruiting |
| Anti-PD-LI/TGF-β trap M7824 versus anti-PD-1 pembrolizumab | NCT03631706 | PD-L1+ NSCLC | II | 1st line | Recruiting |
HCC, hepatocellular carcinoma; HER2, human epidermal growth factor receptor 2; HR+, hormone receptor positive; NSCLC, non-small-cell lung cancer; Refractory, failed prior standard therapy (including subject refusal or intolerance); RCC, renal cell carcinoma