Table 3.
Current clinical trials investigating PTEN-PI3K-AKT pathway and immunotherapy.
| Conditions | Immunotherapy Treatment | Study Description | State | Estimated Enrolment | Study Identifier |
|---|---|---|---|---|---|
| Advanced or metastatic solid tumors | anti PD-L1 durvalumab | This is a Phase I dose-escalation study to evaluate the safety and tolerability of combination treatment of AKT inhibitor AZD5363 + PARP inhibitor olaparib + durvalumab. An exploratory objective is to explore molecular correlates of the relationship between mutations in AKT/PIK3CA/PTEN pathway and treatment response. | Recruiting | 40 participants | NCT03772561 |
| Advanced solid tumors selected for specific molecular alterations, including PTEN mutation | anti PD-L1 durvalumab | This is a Phase Ib study to evaluate effects and best dose of the PI3Kinase inhibitior copanlisib and PARP inhibitor olaparib when given together with durvalumab in patients with molecularly-selected solid tumors including PTEN mutation. | Not yet recruiting | 102 participants | NCT03842228 |
| Metastatic melanoma with PTEN Loss | anti-PD-1 pembrolizumab | This is a Phase I/II study to evaluate objective response rate and overall survival of the selective PI3K-Beta Inhibitor GSK2636771 in combination with pembrolizumab in patients with metastatic melanoma and PTEN Loss. | Recruiting | 41 participants | NCT03131908 |
| Relapsed/refractory mismatch-repair proficient colorectal cancer | anti-PD-1 nivolumab | This is a Phase I/II study to evaluate objective response rate of PI3Kinase inhibitor copanlisib and nivolumab. | Recruiting | 54 participants | NCT03711058 |
| Recurrent/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma | anti-PD-1 nivolumab | This is a Phase II study to evaluate objective response rate of PI3Kinase inhibition copanlisib hydrochloride and nivolumab. | Suspended | 106 participants | NCT03484819 |
| Metastatic triple-negative breast cancer or ovarian cancer | A2aR and A2bR antagonist AB928 | This is a Phase I/Ib study to evaluate safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of immunotherapy combinations. dual adenosine receptor antagonist AB928 in combination with pegylated liposomal doxorubicin with or without PI3kinase-gamma inhibitor IPI-549. | Recruiting | 214 participants | NCT03719326 |
| Non Small Cell Lung Cancer | anti-PD-1 pembrolizumab | This is a Phase Ib/II study to evaluate safety and objective response rate of the standard pembrolizumab in combination with the investigational agent PI3K-delta inhibitor idelalisib. | Recruiting | 40 participants | NCT03257722 |
| HLA-DPB1*04:01 positive adults with advanced cancers | T Cell Receptor Engineered T Cells (KITE-718) | This is a Phase I study to evaluate safety and objective response rate of KITE-718 treated with AKT inhibitor during manufacturing process. | Recruiting | 75 participants | NCT03139370 |