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

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.

Conditions

Melanoma, Squamous Cell Carcinoma of Head and Neck

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Melanoma
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale, New Haven, Connecticut, United States, 06519

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Richmond

Massey Cancer Center, Richmond, Virginia, United States, 23219

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Primary cutaneous melanoma with clinically apparent regional lymph node metastases
  • * Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin
  • * Clinically detected primary cutaneous melanoma involving multiple regional nodal groups
  • * Clinically detected nodal melanoma (if single site) arising from an unknown primary
  • * Relapsed resectable stage III melanoma
  • * Current or prior history of uveal, mucosal, or acral melanoma
  • * Oligometastatic stage IV melanoma
  • * History of in-transit metastases within the last 6 months
  • * Prior therapy targeting BRAF and/or MEK

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

IO Biotech,

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

Study Record Dates

2027-01