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. 2023 Aug 1;10:1148389. doi: 10.3389/fmolb.2023.1148389

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