RecruitingPhase 2NCT05414032

Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC

Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC

Sponsor

University Health Network, Toronto

Enrollment

102 participants

Start Date

Jul 12, 2023

Study Type

INTERVENTIONAL

Conditions

Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Summary

This is a phase II, open-label study to assess the efficacy of AZD2936 in terms of molecular residual disease (MRD) clearance and treatment outcome in patients with MRD after definitive treatment for high risk locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). MRD is defined as ctDNA detection in plasma after definitive treatment. Approximately 100 patients are expected to be enrolled.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a blood test that detects tiny traces of cancer DNA (called circulating tumor DNA, or ctDNA) after treatment can help predict who needs additional therapy for head and neck cancer. It is testing durvalumab (an immunotherapy) in patients who still have detectable cancer DNA in their blood after initial treatment. **You may be eligible if...** - You are 18 or older and weigh at least 35 kg - You have been diagnosed with locally advanced head and neck cancer (oral cavity, oropharynx, hypopharynx, or larynx) confirmed by biopsy - You have an ECOG performance status of 0 or 1 (fully active or slightly limited) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have significant immune system problems or autoimmune diseases - You cannot provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAZD2936

AZD2936 is a monovalent, bispecific, humanized, IgG1 triple mutant mAb antibody against human PD 1 and TIGIT. AZD2936 was constructed on the backbone of the DuetMab molecule (Mazor et al., 2015), and its antigen binding fragment portions are comprised of the variable domains of the anti TIGIT COM902 antibody and anti PD 1 LO115 antibody. The IgG1 Fc domain carries the triple mutation (L234F/L235E/P331S) designed to reduce Fc mediated immune effector functions. In the preclinical studies, dual blockade of TIGIT and PD 1 by AZD2936 enhanced human T cell function and promoted antitumor immune responses.

Locations(1)

Princess Margaret Cancer Centre

Toronto, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05414032