Table 1.

Clinical trials testing MDM2 inhibition in combination with immunotherapy

Cancer entityDesignMDM2 inhibitorImmunotherapyNumber of participantsNCT number
AML Siremadlin (HDM201) alone and in combination with DLI in AML after allo-HCT Siremadlin (HDM201) Allo-HCT, DLI 38 NCT05447663 
AML, MDS Phase 1b, multiarm, open-label study of HDM201 in combination with MBG453 or venetoclax for AML or MDS Siremadlin (HDM201) MBG453 (anti–TIM-3 antibody) 52 NCT03940352 
CRC, NSCLC, BC, RCC Phase 1b study of spartalizumab in combination with HDM201 or LCL161 or everolimus or panobinostat Siremadlin (HDM201) Spartalizumab (anti–PD-1 antibody) 298 NCT02890069 
Advanced liposarcoma or other advanced solid tumors Phase 1b APG-115 in combination with PD-1 inhibitor in patients with advanced liposarcoma or advanced solid tumors APG-115 Anti–PD-1 antibody 92 NCT04785196 
Metastatic melanoma or other advanced solid tumors Phase 1b (part 1) and phase 2 (part 2) APG-115 in combination with pembrolizumab in patients with metastatic melanomas or advanced solid tumors APG-115 Pembrolizumab anti–PD-1 antibody 224 NCT03611868 
Solid tumors Phase 2 (solid tumors) to test different doses of BI 907828 in combination with ezabenlimab, with or without BI 754111 BI-907828 BI 754091 (anti–PD-1) with/without
BI 754111 (anti–LAG-3) 
140 NCT03964233 
CRC Phase 1b/2, open-label, multicenter, randomized study designed to assess the safety and preliminary antitumor activity Idasanutlin (RG7388) Atezolizumab (anti–PD-L1) 94 NCT03555149
Study terminated 
Cancer entityDesignMDM2 inhibitorImmunotherapyNumber of participantsNCT number
AML Siremadlin (HDM201) alone and in combination with DLI in AML after allo-HCT Siremadlin (HDM201) Allo-HCT, DLI 38 NCT05447663 
AML, MDS Phase 1b, multiarm, open-label study of HDM201 in combination with MBG453 or venetoclax for AML or MDS Siremadlin (HDM201) MBG453 (anti–TIM-3 antibody) 52 NCT03940352 
CRC, NSCLC, BC, RCC Phase 1b study of spartalizumab in combination with HDM201 or LCL161 or everolimus or panobinostat Siremadlin (HDM201) Spartalizumab (anti–PD-1 antibody) 298 NCT02890069 
Advanced liposarcoma or other advanced solid tumors Phase 1b APG-115 in combination with PD-1 inhibitor in patients with advanced liposarcoma or advanced solid tumors APG-115 Anti–PD-1 antibody 92 NCT04785196 
Metastatic melanoma or other advanced solid tumors Phase 1b (part 1) and phase 2 (part 2) APG-115 in combination with pembrolizumab in patients with metastatic melanomas or advanced solid tumors APG-115 Pembrolizumab anti–PD-1 antibody 224 NCT03611868 
Solid tumors Phase 2 (solid tumors) to test different doses of BI 907828 in combination with ezabenlimab, with or without BI 754111 BI-907828 BI 754091 (anti–PD-1) with/without
BI 754111 (anti–LAG-3) 
140 NCT03964233 
CRC Phase 1b/2, open-label, multicenter, randomized study designed to assess the safety and preliminary antitumor activity Idasanutlin (RG7388) Atezolizumab (anti–PD-L1) 94 NCT03555149
Study terminated 

BC, breast cancer; CRC, colorectal cancer; DLI, donor lymphocyte infusion; NSCLC, non–small cell lung cancer; RCC, renal cell carcinoma.

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