RecruitingPhase 2NCT05280314

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


Sponsor

IO Biotech

Enrollment

60 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two investigational vaccines (IO102-IO103) together with the immunotherapy drug pembrolizumab (Keytruda) given before and after surgery for patients with resectable (operable) stage III melanoma or advanced head and neck cancer. The goal is to boost the immune system's ability to fight remaining cancer cells after surgery. **You may be eligible if...** - You are 18 or older with stage III melanoma that can be surgically removed, OR with advanced head and neck cancer (certain types) that is suitable for surgery - You have not received any prior treatment for this specific tumor - Your overall health is good (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You have uveal, mucosal, or acral melanoma, or melanoma that has spread to distant organs - You have a history of severe immune-related side effects from prior immunotherapy - You have active autoimmune disease, immune deficiency, or require systemic steroids - You are pregnant or breastfeeding - You have had an organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Yale

New Haven, Connecticut, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Massey Cancer Center

Richmond, Virginia, United States

Melanoma Institute Australia The Uiniversity of Sydney, and Royal North Shore Hospital

Sydney, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Aarhus University Hospital

Aarhus, Denmark

Copenhagen University Hospital Herlev

Copenhagen, Denmark

CHRU Lille

Lille, France

Hôpital Ambroise-Paré

Paris, France

Institut Gustave Roussy

Paris, France

Universitätsklinikum Essen & Research Alliance Ruhr

Essen, Germany

Universität Heidelberg, Medizinische Fakultät

Heidelberg, Germany

Hospital Universitario Quirón Dexeus

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Clínico Universitario de Valencia -INCLIVA

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT05280314


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