Phase II Study of IO102-IO103 and Pembrolizumab (KEYTRUDA®) Before and After Surgery for Patients with Resectable Tumors

Sponsor: IO Biotech

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05280314

Provider View

This clinical trial is testing a combination of two drugs, IO102-IO103 and pembrolizumab (KEYTRUDA®), given before and after surgery to see if they can help control tumors that can be surgically removed. The study involves patients with certain types of cancer, including melanoma and head and neck cancer.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of using IO102-IO103 and pembrolizumab (KEYTRUDA®) as treatments before and after surgery in patients with tumors that can be removed. The trial will include patients with melanoma and squamous cell carcinoma of the head and neck (SCCHN). Participants will receive the treatment before surgery to shrink the tumor and after surgery to prevent the cancer from returning. The study will assess how well the treatment works, its safety, and how it affects the immune system's response to the cancer.

Description

This trial involves patients with melanoma or squamous cell carcinoma of the head and neck (SCCHN) who have tumors that can be surgically removed. The study will test the combination of IO102-IO103 and pembrolizumab (KEYTRUDA®) given before surgery (neoadjuvant treatment) and after surgery (adjuvant treatment).

Participants with melanoma will receive three doses of the treatment before surgery, while those with SCCHN will receive two or three doses, depending on the doctor's decision. Surgery will take place 1 to 3 weeks after the last dose of the pre-surgery treatment. After surgery, all participants will continue to receive the treatment for up to 45 weeks.

The study will measure the response of the tumor to the treatment using imaging and by examining the tumor tissue removed during surgery. Safety will be monitored by recording any side effects. The main goal is to see how many patients have a significant reduction in tumor size after the pre-surgery treatment. The study will also look at how long patients remain free of disease and their overall survival rates. Follow-up visits will occur at 6 and 12 months after the end of treatment, with long-term follow-up every 6 months for at least another year.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage III melanoma or stage III/IVA head and neck cancer that can be surgically removed.
  • Tumors must be measurable by standard criteria.
  • Eligible for surgery with the goal of curing the cancer.
  • Must provide a tumor sample for analysis.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate organ function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • HIV-positive patients must have well-controlled infection.
  • Patients with hepatitis B or C must have undetectable viral loads.

Exclusion Criteria

  • History of certain types of melanoma or head and neck cancer.
  • Previous treatment with specific cancer therapies.
  • Participation in another clinical trial within 4 weeks before starting this study.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • Active infection or other serious medical conditions.
  • Pregnant or breastfeeding women.
  • History of severe allergic reactions to pembrolizumab or its ingredients.
  • Psychiatric or substance abuse issues that could interfere with participation.

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