Intratumoral Injection of Autologous CD1c (BDCA-1)+ myDC, AS01B, and Ipilimumab Plus Systemic Nivolumab

Summary

This phase II trial aims at investigating the role and effect of autologous CD1c (BDCA-1)+ myeloid dendritic cells in combination with intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B compared to a combinatorial immunotherapy regimen using intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B. Concomitantly, nivolumab (a PD-1 blocking mAb) will be administered intravenously in both arms.

Timeline

Start

2018-01-29

Primary completion

2027-04-23

Completion

2027-12-23

Publications

• Tijtgat J, Geeraerts X, Boisson A, Stevens L, Vounckx M, Dirven I, Schwarze JK, Raeymaeckers S, Forsyth R, Van Riet I, Tuyaerts S, Willard-Gallo K, Neyns B. Intratumoral administration of the immunologic adjuvant AS01B in combination with autologous CD1c (BDCA-1)+/CD141 (BDCA-3)+ myeloid dendritic cells plus ipilimumab and intravenous nivolumab in patients with refractory advanced melanoma. J Immunother Cancer. 2024 Jan 11;12(1):e008148. doi: 10.1136/jitc-2023-008148.

Drugs

Indications