Phase II, Multi-cohort Trial of Neoadjuvant and Post-surgery IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Selected Resectable Tumors
IO Biotech
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Melanoma-specific inclusion criteria: • Histologically or cytologically confirmed diagnosis of cutaneous stage III melanoma according to the American Joint Committee on Cancer (AJCC) 8th edition. Patients with resectable tumors are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal metastasis or at the time of clinically detected nodal recurrence; they may belong to any of the following groups: * Primary cutaneous melanoma with clinically apparent regional lymph node metastases * Clinically detected recurrent melanoma at the proximal regional…
Interventions
- DrugIO102-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).
- DrugPembrolizumab KEYTRUDA®
Pembrolizumab KEYTRUDA® administered intravenously
Locations (15)
- YaleNew Haven, Connecticut
- Dana Farber Cancer InstituteBoston, Massachusetts
- Massey Cancer CenterRichmond, Virginia
- Melanoma Institute Australia The Uiniversity of Sydney, and Royal North Shore HospitalSydney, New South Wales
- Peter MacCallum Cancer CentreMelbourne, Victoria
- Aarhus University HospitalAarhus