Actively Recruiting
Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC
Led by University Health Network, Toronto · Updated on 2026-02-25
102
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening or age of consent according to law
- Written informed consent obtained before any study procedures
- ECOG performance status of 0 or 1
- Weight of at least 35 kg
- Life expectancy of at least 12 weeks
- Histologically or cytologically confirmed locoregionally advanced head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, including p16-positive unknown primary
- High-risk HPV negative patients at stage III-IVB or high-risk HPV positive patients at stage III according to AJCC/UICC 8th Edition
- Availability of archival tumor tissue for biomarker studies
- Candidate for definitive treatment such as surgery followed by radiation or chemoradiation, or definitive radiation or chemoradiation
- For Part C: objective radiological tumor response 8-12 weeks after definitive therapy
- For Part C: ECOG performance status 0 or 1 at randomization
- For Part C: tumor must express PD-L1 with CPS ≥1
- For Part C: ctDNA detected in plasma samples collected at week 5 and/or week 10 in Part B
- Adequate organ and marrow function as defined by specific blood and liver function values
- Body mass index of at least 17
- Females of childbearing potential and their male partners must use highly effective contraception during and 4 months after treatment
- For Part E: objective radiological tumor response 8-12 weeks after definitive therapy
- For Part E: no detection of ctDNA in plasma samples at week 10 in Part B
You will not qualify if you...
- Head and neck cancers of other anatomic locations, p16-negative unknown primary, or non-squamous histologies
- Unresolved toxicity grade 2 or higher from previous cancer therapy except alopecia, vitiligo, or defined lab values
- Evidence of distant metastasis
- History of allogeneic organ transplantation
- Allergic reactions to AZD2936 or similar compounds
- Active primary immunodeficiency
- Active or prior autoimmune or inflammatory disorders except specified exceptions
- Active infections including tuberculosis, hepatitis B or C, or acute hepatitis A
- Known HIV infection
- Uncontrolled illness including active infections, heart failure, hypertension, coronary artery disease, arrhythmia, lung disease, chronic gastrointestinal conditions, or psychiatric/social issues limiting study compliance
- History of other cancers except adequately treated low-risk malignancies
- Any concurrent anticancer treatment except allowed hormonal therapy
- Prior therapy with AZD2936, anti-PD-1/L1, or TIGIT antibodies
- Use of immunosuppressive medications within 14 days before study treatment except allowed steroids
- Receipt of live attenuated vaccine within 30 days before study treatment
- Participation in another clinical trial with investigational product within 28 days before randomization
- Investigator judgment deeming participant unable to comply with study requirements
- Pregnant or breastfeeding women
- Involuntarily incarcerated individuals or those unable to give informed consent or comply with the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Canada
Actively Recruiting
Research Team
L
Lillian Siu, MD
CONTACT
M
Minge Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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