NCT05280314

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

Phase II, Multi-cohort Trial of Neoadjuvant and Post-surgery IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Selected Resectable Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: IO Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab KEYTRUDA® as neoadjuvant and post-surgery treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications.

Detailed description

This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab KEYTRUDA® as neoadjuvant and post-surgery treatment. Approximately 60 patients with melanoma or SCCHN will be included (approximately 15 for each indication).During the neoadjuvant period, patients in cohort A, cohort B and Cohort C (Arm A) will receive IO102-IO103 and pembrolizumab KEYTRUDA® Q3W. Patients in Cohort C (Arm B) will receive pembrolizumab KEYTRUDA® Patients with melanoma will receive 3 doses of neoadjuvant treatment. Patients with SCCHN will receive 2 or 3 doses of neoadjuvant treatment, at the investigator's discretion. Surgical resection will be performed 1 to 3 weeks after the last dose of neoadjuvant treatment. All patients in cohort A,B and Cohort C (Arm A)will receive post-surgery treatment with IO102-IO103 and pembrolizumab KEYTRUDA® for a total of 15 cycles (up to 45 weeks). Patients in Cohort C (Arm B) will receive post-surgery treatment with pembrolizumab KEYTRUDA® for a total of 15 cycles (up to 45 weeks). Patients with melanoma and patients with SCCHN who do not require SOC RT ± cisplatin will start post-surgery treatment after adequate recovery from surgery (approximately 1 to 2 months; no more than 12 weeks).Patients with SCCHN who require postoperative SOC therapy after surgery will start post-surgery IO102-IO103 and pembrolizumab KEYTRUDA® after adequate recovery from SOC therapy (approximately 1 to 2 months; no more than 12 weeks). Objective response will be based on imaging; pathologic tumor response of the surgical specimens will be assessed at the time of surgery. Safety will be assessed by recording adverse events. The primary endpoint will be the percentage of patients with major pathologic response (MPR) in the resected tumor tissue after neoadjuvant treatment. Secondary endpoints include disease-free survival (DFS) at 2 years after surgery. All patients will have an end-of-treatment visit approximately 4 weeks after their last dose of trial treatment. Follow-up visits will be conducted at 6 and 12 months after the end-of-treatment visit. Following completion of the 12-month follow-up period, long-term follow-up for overall survival (OS) will be conducted every 6 months for at least a further 12 month.

Conditions

• Melanoma
• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	IO102-IO103	IO102-IO103 is a combination of an indoleamine 2,3-dioxygenase 1 (IDO1) peptide (IO102) and a programmed death-ligand 1 (PD-L1) peptide (IO103), emulsified with an adjuvant (Montanide ISA 51 VG).
DRUG	Pembrolizumab KEYTRUDA®	Pembrolizumab KEYTRUDA® administered intravenously

Timeline

• Start date: 2023-12-21
• Primary completion: 2025-04-30
• Completion: 2027-01-01
• First posted: 2022-03-15
• Last updated: 2024-03-18

Locations

15 sites across 6 countries: United States, Australia, Denmark, France, Germany, Spain

Regulatory

• FDA-regulated drug study