NCT05077709

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

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 NSCLC, SCCHN, or Metastatic mUBC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: IO Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Lung Cancer Non Small Cell
• Head and Neck Squamous Cell Carcinoma
• Urothelial Carcinoma Bladder

Interventions

Type	Name	Description
DRUG	IO102-IO103 in combination with pembrolizumab	The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides

Timeline

• Start date: 2022-04-11
• Primary completion: 2025-11-30
• Completion: 2026-02-08
• First posted: 2021-10-14
• Last updated: 2026-04-08
• Results posted: 2026-04-08

Locations

21 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated drug study