RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications.

Official Title

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

Quick Facts

Study Start:2023-12-21
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05280314

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary cutaneous melanoma with clinically apparent regional lymph node metastases
  2. * Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin
  3. * Clinically detected primary cutaneous melanoma involving multiple regional nodal groups
  4. * Clinically detected nodal melanoma (if single site) arising from an unknown primary
  5. * Relapsed resectable stage III melanoma
  1. * Current or prior history of uveal, mucosal, or acral melanoma
  2. * Oligometastatic stage IV melanoma
  3. * History of in-transit metastases within the last 6 months
  4. * Prior therapy targeting BRAF and/or MEK

Contacts and Locations

Study Contact

Diane McDowell SVP, Clinical Development and Medical Affairs, MD
CONTACT
+1 267 252 7296
dmd@iobiotech.com
Shane O'Neill Clinical Program Director
CONTACT
+44 790 433 7285
son@iobiotech.com

Principal Investigator

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

Study Locations (Sites)

Yale
New Haven, Connecticut, 06519
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Massey Cancer Center
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: IO Biotech

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-21
Study Completion Date2027-01

Study Record Updates

Study Start Date2023-12-21
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Melanoma
  • Squamous Cell Carcinoma of Head and Neck