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PD-L1 Inhibitor
Dostarlimab for Head and Neck Cancer (JADE Trial)
Melbourne, Australia
Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have newly diagnosed unresected LA histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx and completed cisplatin plus radiotherapy with curative intent and no evidence of distant metastatic disease
Participants must have provided acceptable core or excisional tissue demonstrating PD-L1 positive tumor status
Must not have
Participants with any history of interstitial lung disease or pneumonitis
Participants with cancer outside of the oropharynx, larynx, hypopharynx, or oral cavity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Pivotal Trial
Summary
"This trial will determine if Dostarlimab is safe and effective compared to a placebo for adults with Head and Neck Squamous Cell Carcinoma."
See full description
Who is the study for?
This trial is for adults with locally advanced head and neck squamous cell carcinoma that cannot be removed by surgery. Participants should have completed chemoradiation therapy. Specific eligibility criteria are not provided, but typically include good organ function and no other serious medical conditions.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of Dostarlimab, an immunotherapy drug, compared to a placebo (a substance with no active drug). It aims to see if Dostarlimab can improve outcomes after standard treatment with chemoradiation.See study design
What are the potential side effects?
Dostarlimab may cause side effects similar to other immunotherapies which can include fatigue, rash, diarrhea, liver inflammation, hormone gland problems like thyroid disorders, and could potentially worsen pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a specific type of throat or mouth cancer, treated with cisplatin and radiotherapy, with no spread to distant parts.
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My tumor is PD-L1 positive based on a specific tissue test.
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I am fully active or restricted in physically strenuous activity but can do light work.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of lung scarring or inflammation.
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My cancer is not located in the throat or mouth.
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I have cirrhosis or a current unstable liver condition.
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I have been treated with specific immune therapy for cancer.
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I have severe allergies to certain antibodies or the ingredients in dostarlimab.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Secondary study objectives
Event-free Survival (EFS) assessed by investigator
Overall Survival (OS)
Side effects data
From 2022 Phase 2 trial • 18 Patients • NCT0440900280%
Anemia
80%
Fatigue
73%
Abdominal pain
67%
CD4 lymphocytes decreased
67%
Alkaline phosphatase increased
67%
Nausea
60%
Anorexia
60%
Constipation
53%
Platelet count decreased
53%
Hyperglycemia
47%
Thromboembolic event
47%
Weight loss
47%
Anxiety
47%
Hypoalbuminemia
40%
Vomiting
40%
Peripheral motor neuropathy
40%
Blood bilirubin increased
40%
Dyspnea
40%
Hypertension
33%
Edema limbs
33%
Abdominal distension
33%
Aortic valve disease
33%
Back pain
33%
Diarrhea
33%
Fever
33%
Hypocalcemia
33%
Sinus tachycardia
27%
Depression
27%
White blood cell decreased
27%
Chills
27%
Ascites
27%
Hyponatremia
20%
Urine discoloration
20%
Pain
20%
Paresthesia
20%
Sore throat
20%
Delirium
20%
Cough
20%
Dizziness
20%
Lymphocyte count decreased
13%
Neutrophil count decreased
13%
Palpitations
13%
Insomnia
13%
Thrush
13%
Pain in extremity
13%
Confusion
13%
Dehydration
13%
Fall
13%
Cardiac troponin T increased
13%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Bloating
13%
Dry mouth
13%
Dysphagia
13%
Dysuria
13%
Flatulence
13%
Gastroesophageal reflux disease
13%
Glucosuria
13%
Hiccups
13%
Hypercalcemia
13%
Hyperkalemia
13%
Hypokalemia
13%
Hypophosphatemia
13%
Hypothyroidism
13%
Localized edema
7%
Superficial thrombophlebitis
7%
Oral hemorrhage
7%
Oral pain
7%
Stroke
7%
Hematuria
7%
Skin infection
7%
Obesity
7%
Urinary frequency
7%
Hemorrhoidal hemorrhage
7%
Erectile dysfunction
7%
Osteoporosis
7%
Papulopustular rash
7%
Tremor
7%
Urinary retention
7%
Generalized muscle weakness
7%
Thyroid stimulating hormone increased
7%
Skin ulceration
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Encephalopathy
7%
Endocarditis infective
7%
Eye disorders - Other, specify
7%
Pelvic pain
7%
Prostatic obstruction
7%
Pruritus
7%
Rash acneiform
7%
Rectal pain
7%
Renal calculi
7%
Reproductive system and breast disorders - Other, specify
7%
Wheezing
7%
Portal vein thrombosis
7%
Vaginal dryness
7%
Alopecia
7%
Arthralgia
7%
Arthritis
7%
Bacteremia
7%
Biliary tract infection
7%
Blood lactate dehydrogenase increased
7%
Buttock pain
7%
Dry skin
7%
Dysgeusia
7%
Flank pain
7%
Gastric anastomotic leak
7%
Gastric ulcer
7%
Gastritis
7%
Gastrointestinal disorders - Other, specify
7%
Gastrointestinal pain
7%
Hyperlipidemia
7%
Hypoglycemia
7%
Lethargy
7%
Memory impairment
7%
Mucositis oral
7%
Muscle cramp
7%
Muscle weakness lower limb
7%
Myocarditis
7%
Restlessness
7%
Scleral disorder
7%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Niraparib+Dostarlimab + Radiation
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: DostarlimabExperimental Treatment1 Intervention
Group II: Arm B: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2019
Completed Phase 3
~2180
Find a Location
Closest Location:GSK Investigational Site· Cincinnati, OH· 99 miles
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,830 Previous Clinical Trials
8,387,165 Total Patients Enrolled