This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment.This proof-of-concept trial will include patients with resectable tumors in at least 2 indications. Eligible patients will be scheduled for surgery, such that neoadjuvant treatment can start 6 weeks before the planned date of surgery. During the neoadjuvant period, patients will receive IO102-IO103 weekly (6 doses) and pembrolizumab every 3 weeks (Q3W) (2 doses). After recovery from surgery, patients may receive risk-based post-operative standard of care (SOC) therapy, i.e., observation, radiotherapy, and/or chemotherapy. Patients who receive SOC chemotherapy/radiotherapy will start adjuvant IO102-IO103 and pembrolizumab after adequate recovery from SOC therapy. Patients who do not require SOC chemotherapy/radiotherapy will start adjuvant IO102-IO103 and pembrolizumab after adequate recovery from surgery. Each recovery period (after surgery or after SOC) is expected to be 1 to 2 months, but should be no more than 13 weeks. All patients will receive adjuvant treatment with IO102-IO103 and pembrolizumab for 12 months. 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 a further 2 years.
This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications.