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

NCT05280314 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-18

No results posted yet for this study

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.

Conditions

  • Melanoma
  • Squamous Cell Carcinoma of Head and Neck

Interventions

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

Sponsors & Collaborators

  • Theradex

    collaborator INDUSTRY

  • Almac

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • IO Biotech

    lead INDUSTRY

Principal Investigators

  • Barbara Burtness, MD, Prof · Yale New Haven Hospital - Yale Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2025-04-30
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Denmark
  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05280314 on ClinicalTrials.gov