Study on IO102-IO103 and Pembrolizumab for First-line Treatment of Advanced Lung, Head and Neck, or Bladder Cancer

Sponsor: IO Biotech

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05077709

Provider View

This clinical trial is testing a new combination of treatments, IO102-IO103 and pembrolizumab, to see if they are safe and effective as a first treatment for patients with advanced lung, head and neck, or bladder cancer.

Patient Parameters

Program Overview

The study aims to find out if combining IO102-IO103 with pembrolizumab can help treat patients with advanced forms of non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head or neck (SCCHN), or metastatic urothelial bladder cancer (mUBC). Researchers want to see if this combination can improve outcomes for patients who have not received any prior treatment for their metastatic cancer.

Description

This trial is exploring a new treatment approach using IO102-IO103, which targets specific proteins on cancer cells, in combination with pembrolizumab, an immunotherapy drug. The goal is to enhance the body's natural ability to fight cancer by boosting the immune system's response. The study will include about 90 patients, divided into three groups based on their type of cancer: lung, head and neck, or bladder. Each patient will receive the treatment for up to two years, with regular monitoring to assess the effectiveness and safety of the therapy.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC), head and neck cancer (SCCHN), or bladder cancer (mUBC) that has spread and cannot be treated with surgery.
  • Have not received any previous treatment for their metastatic cancer.
  • Have tumors that express a specific protein called PD-L1 at certain levels, depending on the type of cancer.
  • Be at least 18 years old.
  • Have measurable disease that can be tracked using scans.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Agree to use effective contraception during the study and for a specified period after the last dose of treatment.
  • Provide a blood sample and a tumor tissue sample for analysis.
  • Have adequate organ function as determined by specific blood tests.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have received previous treatment with similar immunotherapy drugs.
  • Have received prior systemic anti-cancer therapy for their metastatic disease.
  • Have active infections or other serious medical conditions that could interfere with the study.
  • Have a history of severe allergic reactions to the study drugs.
  • Have active autoimmune diseases requiring treatment in the past two years.
  • Have known infections like HIV, hepatitis B, or hepatitis C.
  • Have a history of organ transplant.
  • Have psychiatric or substance abuse disorders that could interfere with participation in the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.