Naturally occurring IDO/PD-L1 specific T-cells recognize MHC-bound IDO/PD-L1 peptides, and are able to eliminate IDO expressing or PD-L1 expressing immune regulatory cells and cancer cells. Activation of IDO or PD-L1 specific T-cells through vaccination with the IDO and PD-L1 peptides (IO102-IO103) will boost natural killing of cancer cells and counteract immune regulatory mechanisms in the tumor microenvironment. Thus, IDO/PD-L1 specific T-cells may both directly support anti-cancer immunity by killing target T-cells but also indirectly by releasing pro-inflammatory cytokines in the microenvironment to boost additional anti-cancer immunity.~This is a non comparative, open label, unblinded, multi-arm (basket) trial of IO102-IO103 in combination with pembrolizumab in three indications: NSCLC, SCCHN or mUBC. The primary objective of the trial is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab in the frontline treatment in each of the different metastatic solid tumour indications with the intent to expand a specific arm if a clinically meaningful signal is observed based on primary endpoint (dual target of either ORR or PFS by investigator assessment according to RECIST v.1.1).~Approximately 90 patients will be enrolled and treated; approximately 30 patients in each arm. All eligible patients will receive treatment for up to 2 years with IO102-IO103 (IO102 85μg and IO103 185μg) SC Q3W in combination with pembrolizumab IV 200mg Q3W.
A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head or Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC)