TABLE 2.
Clinical trials involving p53 activation to induce an immune response.
ID | Intervention | Cancer Type | Status | Outcome | Ref. |
---|---|---|---|---|---|
p53 activation + immune checkpoint inhibition | |||||
NCT04785196 | APG-115 + toripalimab | Liposarcoma & advanced solid tumors | Recruiting | Not yet available | |
NCT03611868 | APG-115 + pembrolizumab | Solid tumors | Recruiting | Not yet available | Fang et al. (2019) |
NCT04383938 | PRIMA-1Met (APR-246) + pembrolizumab | Solid tumors | Completed | Acceptable safety profile; clinical activity in patients with solid tumors | Dumbrava et al. (2021), Park et al. (2022) |
p53 vaccines -/+ immune checkpoint inhibition | |||||
NCT01191684 | p53MVA | Colorectal, stomach, or pancreatic cancer | Completed | Elevated p53-specific CD8+ T cell responses; clinical response not apparent | Chung et al. (2019) |
NCT03113487 | p53MVA + pembrolizumab | Recurrent ovarian, primary peritoneal, or fallopian tube cancer | Active, not recruiting | Not yet available | |
NCT02432963 | p53MVA + pembrolizumab | Solid tumors that have failed prior therapy | Active, not recruiting | 3/11 patients SD for 30, 32, and 49 weeks with p53-specific T cells; 7/11 patients PD before 10 weeks, minimal p53-specific T cell responses, no clinical benefit | Chung et al. (2019) |
NCT03406715 | Ad.p53-DC + nivolumab & ipilimumab | Small cell lung cancer | Terminated | Not yet available | |
NCT01639885 | SLP-p53 + IFN-α2b | Platinum-resistant ovarian cancer | Completed | Not yet available | |
NCT00844506 | SLP-p53 + cyclophosphamide | Ovarian cancer | Completed | Not yet available | |
NCT00617409 | Paclitaxel -/+ INGN 225 | Small cell lung cancer | Completed | Positive immune response in 20% of paclitaxel -/+ INGN 225 arm. Failed to improve ORR compared to paclitaxel alone. | Chiappori et al. (2019) |
Unknown | ALVAC-p53 | Advanced colorectal cancer | Completed | Potent T-cell and IgG responses induced in the majority of the patients | van der Burg et al. (2002) |
SD, stable disease; PD, progressive disease