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Monoclonal Antibodies

AZD2936 for Head and Neck Cancer (MERIDIAN Trial)

Phase 2
Recruiting
Led By Lillian Siu, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
High-risk HPV negative or positive LA-HNSCC patients
Weight ≥ 35 kg
Must not have
Active or prior documented autoimmune or inflammatory disorders
Receipt of live attenuated vaccine within 30 days prior to study intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests AZD2936, a new drug, in patients with high-risk head and neck cancer who still have cancer DNA in their blood. The drug aims to clear out any leftover cancer cells by targeting the cancer DNA found in the blood.

Who is the study for?
This trial is for adults with advanced head and neck squamous cell carcinoma (LA-HNSCC) who have detectable cancer DNA in their blood after initial treatment. They must be able to perform daily activities with ease or with some limitation (ECOG 0-1), weigh at least 35 kg, and have a life expectancy of over 12 weeks.
What is being tested?
The study tests AZD2936's ability to clear molecular residual disease (MRD), which is cancer DNA found in the blood post-treatment, in patients with high-risk LA-HNSCC. It's an open-label phase II trial where around 200 participants will receive this experimental therapy.
What are the potential side effects?
While specific side effects of AZD2936 are not provided here, similar drugs often cause fatigue, nausea, skin reactions, and increased risk of infections. Side effects can vary based on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My head or neck cancer is either high-risk HPV positive or negative.
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I weigh at least 35 kilograms.
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My cancer in the head or neck area has been confirmed by lab tests.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had an autoimmune or inflammatory disorder.
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I have not received a live vaccine in the last 30 days.
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My cancer has spread to distant parts of my body.
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My cancer is in the head or neck, but not in the areas doctors usually specify.
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I have had another type of cancer in the past.
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I do not have any unmanaged ongoing illnesses.
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I do not have an active infection like TB or hepatitis.
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I have no ongoing major side effects from previous cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy (in terms of ctDNA clearance) of AZD2936 compared to observation (Standard of Care, SOC) in LA-HNSCC patients who have MRD (MRD+) after definitive treatment.
Secondary study objectives
Efficacy (in terms of MRD control) of AZD2936 compared to observation (SOC) in MRD+ LA-HNSCC patients after definitive treatment.
Efficacy (in terms of delaying or preventing radiological recurrence of disease or death) of AZD2936 compared to observation (SOC) in MRD+ LA-HNSCC patients after definitive treatment.
Efficacy (in terms of median DFS and OS) of AZD2936 compared to observation (SOC) in MRD+ LA-HNSCC patients after definitive treatment.
+1 more
Other study objectives
Correlation between radiological response and changes in quantitative bespoke ctDNA and HPV DNA measurements.
Cost effectiveness of the experimental arm vs observation at various time through the study using the EQ-5D-5L.
Health related quality of life at various time points throughout the study using the FACT-ICM and EORTC HN43 tool.
+6 more

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385
75%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Alkaline phosphatase increased
18%
Insomnia
18%
Non-cardiac chest pain
18%
Aspartate aminotransferase increased
18%
Headache
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
15%
Peripheral sensory neuropathy
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Neutrophil count decreased
10%
Arthralgia
10%
Dizziness
10%
Edema limbs
8%
Anxiety
8%
Oral dysesthesia
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Allergic rhinitis
5%
Pleural effusion
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Vertigo
3%
Oral pain
3%
Alopecia
3%
Tracheostomy site bleeding
3%
Pharyngeal hemorrhage
3%
Laryngeal obstruction
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral motor neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: MRD positive Cohort - Arm A (treatment)Experimental Treatment1 Intervention
Dose formulation- AZD2936 is supplied as a liquid drug product in a 20R vial containing 750 mg (nominal) of active AZD2936. The solution contains 50 mg/mL AZD2936 in 20 mM L-histidine/L- histidine-hydrochloride, 240 mM sucrose, 0.04% (w/v) poloxamer 188, at pH 6.0. Unit dose strength(s)- 750 mg/vial (50 mg/mL) Dosage levels- 750mg administered Q3W Route of administration- IV infusion over 1 hour
Group II: MRD negative CohortActive Control1 Intervention
Observation
Group III: MRD positive Cohort - Arm B (observation)Active Control1 Intervention
Observation

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include radiotherapy, chemotherapy, and targeted molecular therapies. Radiotherapy damages the DNA of cancer cells, leading to their death. Chemotherapy agents like cisplatin and docetaxel disrupt cell division and induce apoptosis. Targeted therapies, such as EGFR inhibitors, block specific pathways that cancer cells use to grow and proliferate. These mechanisms are important for HNSCC patients as they help in selecting effective treatments, improving survival rates, and minimizing side effects.
Analysis of Laser Therapy Effects on Squamous Cell Carcinoma Patients: A System Biology Study.Inhibition of SphK1 reduces radiation-induced migration and enhances sensitivity to cetuximab treatment by affecting the EGFR / SphK1 crosstalk.Molecular targeted therapies in all histologies of head and neck cancers: an update.

Find a Location

Who is running the clinical trial?

NeoGenomics LaboratoriesUNKNOWN
University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,044 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,667 Previous Clinical Trials
3,228,291 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05414032 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: MRD negative Cohort, MRD positive Cohort - Arm B (observation), MRD positive Cohort - Arm A (treatment)
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT05414032 — Phase 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05414032 — Phase 2
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