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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
MERIDIAN Trial Summary
This trial will examine how well AZD2936 works to reduce cancer cells in head and neck cancer patients after treatment. 200 patients will be studied.
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.Check my eligibility
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.See study design
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.
MERIDIAN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My head or neck cancer is either high-risk HPV positive or negative.
Select...
I weigh at least 35 kilograms.
Select...
My cancer in the head or neck area has been confirmed by lab tests.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
MERIDIAN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreOther outcome measures
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 moreSide effects data
From 2013 Phase 2 trial • 86 Patients • NCT0125638575%
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%
Non-cardiac chest pain
18%
Alkaline phosphatase increased
18%
Aspartate aminotransferase increased
18%
Insomnia
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%
Dizziness
10%
Arthralgia
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%
Tracheostomy site bleeding
3%
Vertigo
3%
Alopecia
3%
Oral pain
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)
MERIDIAN 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
Find a Location
Who is running the clinical trial?
NeoGenomics LaboratoriesUNKNOWN
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
484,980 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,620 Previous Clinical Trials
3,216,399 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My head or neck cancer is either high-risk HPV positive or negative.I have or had an autoimmune or inflammatory disorder.My cancer has spread to distant parts of my body.My cancer is in the head or neck, but not in the areas doctors usually specify.I have had another type of cancer in the past.I am taking or have taken certain medications.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I weigh at least 35 kilograms.My cancer in the head or neck area has been confirmed by lab tests.I am eligible for a treatment aimed at curing my condition.I do not have any unmanaged ongoing illnesses.I am fully active or restricted in physically strenuous activity but can do light work.I do not have an active infection like TB or hepatitis.I have no ongoing major side effects from previous cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: MRD negative Cohort
- Group 2: MRD positive Cohort - Arm B (observation)
- Group 3: MRD positive Cohort - Arm A (treatment)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there availability for volunteers to participate in this clinical research?
"This clinical trial, first posted on July 12th 2023 and updated 4 days later is currently recruiting patients. The information can be found online via clinicaltrials.gov."
Answered by AI
What is the cap on participant numbers for this clinical trial?
"Affirmative, the clinicaltrials.gov website suggests that this study is currently in need of participants. The trial was posted on July 12th 2023 and has since been revised on July 17th 2023; 200 patients are being sought at a single site."
Answered by AI
Could you elucidate the potential hazards of participating in MRD positive Cohort - Arm A (treatment)?
"The safety of MRD positive Cohort - Arm A (treatment) was rated a 2, given that there is evidence supporting its security but none in regards to efficacy."
Answered by AI
What potential results are hoped to be achieved from this clinical experiment?
"The main purpose of this 3 year trial is to assess the efficacy, safety and tolerability of monalizumab and cetuximab at clearing circulating tumor DNA (ctDNA) in patients with locoregionally advanced head & neck squamous cell carcinoma that have minimal residual disease (MRD+) after definitive treatment. Secondary objectives include evaluating MRD control failure by observing two consecutive increases in ctDNAs levels over weeks 2 and 10, assessing 12 month Disease Free Survival as an indicator for delaying or preventing radiological recurrence of disease or death, as well as recording any adverse events related to treatment according to"
Answered by AI
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