IO102-IO103

DRUG5 trials

Sponsors

IO Biotech ApS, Io Biotech ApS, IO Biotech

Conditions

MelanomaMelanoma and squamous cell carcinoma of the head and neckMetastatic MelanomaMetastatic Non-Small Cell Lung Cancer (NSCLC)Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)Metastatic Urothelial Bladder Cancer (mUBC)Previously untreatedSquamous Cell Carcinoma of Head and Neck

Phase 2

Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors

RecruitingNCT05280314

IO BiotechMelanoma, Squamous Cell Carcinoma of Head and Neck

Start: 2023-12-21End: 2027-01-31Target: 60Updated: 2024-03-18

Phase II, multi‑cohort trial of neoadjuvant and post‑surgery IO102‑IO103 and pembrolizumab in patients with selected resectable tumors

Active, not recruitingCTIS2022-502787-20-00

IO Biotech ApSMelanoma and squamous cell carcinoma of the head and neck

Start: 2023-09-28Target: 65Updated: 2025-03-26

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 and Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC)

CompletedCTIS2024-511561-10-00

Io Biotech ApSMetastatic Non-Small Cell Lung Cancer (NSCLC), Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN), Metastatic Urothelial Bladder Cancer (mUBC)

Start: 2022-05-31End: 2025-11-28Target: 38Updated: 2025-05-14

Phase 3

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

Active, not recruitingNCT05155254

IO BiotechMetastatic Melanoma, Unresectable Melanoma

Start: 2022-05-17End: 2027-09-30Updated: 2025-08-28

An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (advanced) melanoma

Active, not recruitingCTIS2024-511996-13-00

Io Biotech ApSor metastatic melanoma, Previously untreated, unresectable

Start: 2022-05-11Target: 327Updated: 2025-11-25

Related Papers

Abstract CT240: IOB-032/PN-E40: A phase 2 study of neoadjuvant/adjuvant IO102-IO103 cancer vaccine plus pembrolizumab in resectable HNSCC

Cancer Research2026-04-17

A randomized phase 2 trial of the IO102-IO103 (IDO and PD-L1) cancer vaccine plus pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumors.

Journal of Clinical Oncology2024-06-013 citations

A phase 2 trial of IO102-IO103 and nivolumab-relatlimab fixed-dose combination in previously untreated, unresectable melanoma.

Journal of Clinical Oncology2024-06-011 citations

Long-term follow-up of anti-PD-1 naïve patients with metastatic melanoma treated with IDO/PD-L1 targeting peptide vaccine and nivolumab

Journal for ImmunoTherapy of Cancer2023-05-0131 citations

1440 Arginase-1 peptide-based vaccine is an exciting approach to modulate the tumor microenvironment and drive efficacy in preclinical tumor models

Regular and Young Investigator Award Abstracts2022-11-01

Randomized phase 3 trial of IO102-IO103 plus pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic melanoma.

Journal of Clinical Oncology2022-06-014 citations