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Monoclonal Antibodies
PDR001 + Trametinib/Dabrafenib for Thyroid Cancer
Phase 2
Waitlist Available
Led By Alan L Ho, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be able to swallow and retain orally-administered pills without any clinically significant gastrointestinal abnormalities
Patients must have tissue from the primary tumor or metastases available for correlative studies
Must not have
Known history of current interstitial lung disease or non-infectious pneumonitis
Symptomatic metastatic brain or leptomeningeal tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether PDR001, in combination with either trametinib or dabrafenib, can safely and effectively treat thyroid cancer.
Who is the study for?
Adults with certain types of thyroid cancer that have progressed despite previous treatments and can't be cured with surgery or radiation. They must not have a specific mutation (BRAFV600-), should be in good physical condition, able to swallow pills, and not on immunosuppressive drugs. Pregnant women or those who might become pregnant without contraception are excluded.
What is being tested?
The trial is testing the effectiveness of PDR001 combined with trametinib or dabrafenib for treating advanced thyroid cancer. It aims to determine if this combination therapy is safe and beneficial for patients whose cancer has continued to progress after other treatments.
What are the potential side effects?
Potential side effects may include allergic reactions to monoclonal antibodies, issues from oral medications like gastrointestinal problems, increased risk of infections due to immune system suppression, and possibly others related to heart health as indicated by the eligibility criteria.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills without any major stomach or intestine problems.
Select...
I have tissue samples from my cancer available for study.
Select...
My thyroid cancer comes from follicular cells.
Select...
I am older than 18 years.
Select...
My thyroid tumor has a specific BRAF mutation.
Select...
I have had BRAF therapy for my cancer and tolerated it well without severe side effects.
Select...
I have not recently been treated for thyroid cancer.
Select...
My cancer has returned or spread and cannot be cured with surgery or radiation.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My thyroid cancer does not respond to radioactive iodine treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of lung disease not caused by infections.
Select...
I have symptoms from cancer spread to my brain or its coverings.
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I have had a bone marrow or organ transplant from another person.
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I have received treatment targeting the PD1/PD-L1 pathway.
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I have a specific eye condition.
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I have been treated with a MEK 1/2 inhibitor before.
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I do not have active hepatitis B, HIV, or active hepatitis C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate
Side effects data
From 2019 Phase 1 & 2 trial • 172 Patients • NCT0232573973%
Diarrhoea
48%
Aspartate aminotransferase increased
43%
Alanine aminotransferase increased
27%
Decreased appetite
23%
Nausea
20%
Blood bilirubin increased
20%
Pyrexia
19%
Fatigue
19%
Vomiting
19%
Oedema peripheral
19%
Abdominal pain
17%
Pruritus
15%
Asthenia
14%
Constipation
13%
Anaemia
12%
Blood alkaline phosphatase increased
12%
Cough
12%
Abdominal pain upper
11%
Ascites
11%
Gamma-glutamyltransferase increased
10%
Dyspnoea
10%
Insomnia
9%
Abdominal distension
9%
Back pain
8%
Weight decreased
8%
Lipase increased
8%
Hyperphosphataemia
8%
Hypoalbuminaemia
8%
Headache
7%
Musculoskeletal pain
5%
Hypertension
5%
Hyponatraemia
5%
Dry skin
5%
Rash
4%
Dysgeusia
4%
Nasopharyngitis
4%
Procedural pain
4%
Productive cough
4%
Platelet count decreased
3%
Hepatic pain
3%
Anxiety
3%
Hyperlipasaemia
3%
Myalgia
3%
Dysphagia
3%
Dry mouth
3%
Rhinitis
3%
Chills
3%
Arthralgia
3%
Blood creatinine increased
3%
Hyperglycaemia
3%
Hypokalaemia
3%
Haemoptysis
3%
Gastrooesophageal reflux disease
3%
Blood creatine phosphokinase increased
2%
Abdominal discomfort
2%
Peripheral swelling
2%
Hyperkalaemia
2%
Dizziness
2%
Stomatitis
2%
Night sweats
2%
Epistaxis
2%
Pleural effusion
2%
Upper gastrointestinal haemorrhage
2%
Dyspepsia
2%
Melaena
2%
Bronchitis
2%
Jaundice
2%
Oesophageal varices haemorrhage
2%
Haematemesis
2%
Hyperbilirubinaemia
2%
Hypertriglyceridaemia
2%
Neutrophil count decreased
2%
Pain in extremity
2%
Hepatocellular injury
2%
Malaise
2%
Oedema
2%
Pain
2%
Leukopenia
2%
Duodenal ulcer
2%
Pneumonia
2%
Urinary tract infection
2%
Amylase increased
2%
C-reactive protein increased
2%
Transaminases increased
2%
Hypercalcaemia
2%
Hypophosphataemia
2%
Flank pain
2%
Muscle spasms
2%
Musculoskeletal chest pain
2%
Oropharyngeal pain
2%
Dysphonia
1%
Rash macular
1%
Varicocele
1%
Hypomagnesaemia
1%
Sinusitis
1%
Liver carcinoma ruptured
1%
Haemorrhage intracranial
1%
Paraparesis
1%
Acute kidney injury
1%
Bleeding varicose vein
1%
Hypovolaemic shock
1%
Hyperthyroidism
1%
Varices oesophageal
1%
Folliculitis
1%
Gastroenteritis
1%
Sleep disorder
1%
Hypoglycaemia
1%
Gastritis
1%
Pulmonary embolism
1%
Oesophageal stenosis
1%
Angular cheilitis
1%
Venous thrombosis
1%
Hepatic cirrhosis
1%
Vertigo
1%
Pneumonitis
1%
Haematoma
1%
Cholangitis
1%
Spinal cord compression
1%
Spinal pain
1%
Biloma
1%
Herpes zoster
1%
Calculus urinary
1%
Atelectasis
1%
Thrombocytopenia
1%
Hepatic function abnormal
1%
Malnutrition
1%
Gastric varices
1%
Animal bite
1%
Abdominal tenderness
1%
Groin pain
1%
Dyspnoea exertional
1%
Confusional state
1%
Blood albumin decreased
1%
Gastrointestinal sounds abnormal
1%
Gastrointestinal haemorrhage
1%
Bilirubin conjugated increased
1%
Female genital tract fistula
1%
Bronchostenosis
1%
Haemorrhoidal haemorrhage
1%
Prothrombin time prolonged
1%
Cancer pain
1%
Tumour thrombosis
1%
Bone contusion
1%
Rash pustular
1%
Oesophageal ulcer
1%
Hyperuricaemia
1%
Tumour associated fever
1%
Hepatomegaly
1%
Hepatorenal syndrome
1%
General physical health deterioration
1%
Hernia
1%
Acute coronary syndrome
1%
Coronary artery disease
1%
Haemorrhoids
1%
Rash maculo-papular
1%
Cholestasis
1%
Hepatic haematoma
1%
Pyelonephritis acute
1%
Varicella
1%
Cerebrovascular accident
1%
Dysarthria
1%
Paraesthesia
1%
Paraplegia
1%
Urinary retention
1%
Aneurysm
1%
Hyperglobulinaemia
1%
Toothache
1%
Chest discomfort
1%
Candida infection
1%
Herpes virus infection
1%
Tinea cruris
1%
Activated partial thromboplastin time prolonged
1%
Blood cholesterol increased
1%
Blood phosphorus decreased
1%
Haemoglobin decreased
1%
Osteoporosis
1%
Visual field defect
1%
Scrotal oedema
1%
Carotid artery stenosis
1%
Lymphopenia
1%
Jaundice cholestatic
1%
Peripheral sensory neuropathy
1%
Hot flush
1%
Duodenal obstruction
1%
Gait disturbance
1%
Palpitations
1%
Depression
1%
Multiple organ dysfunction syndrome
1%
Lung infection
1%
Bronchial obstruction
1%
Vena cava thrombosis
1%
Inferior vena caval occlusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Patients
Phase I: 80 mg Fed
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 120 mg Fasted
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
Phase I: FGF401 80 mg + PDR001 300 mg
Phase II: Group 2 - FGF401 120 mg QD
Phase II: Group 3 - FGF401 120 mg QD
All Patients of Single Agent FGF401
Phase I: FGF401 120 mg + PDR001 300 mg
All Patients of Combination Dose
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B-BRAF MutantExperimental Treatment2 Interventions
Cohort B (BRAF Mutant, resistant to previous BRAF inhibitors): dabrafenib (D) 150 mg twice daily (OR at dose the patient previously tolerated) plus PDR001 400mg IV every 4 weeks.
Group II: Cohort A-BRAF WT tumorsExperimental Treatment2 Interventions
Cohort A (BRAF WT tumors): trametinib (T) 2mg by mouth daily plus PDR001 400mg IV every 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~4120
PDR001
2016
Completed Phase 2
~2890
Trametinib
2014
Completed Phase 2
~1630
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,481 Total Patients Enrolled
Alan L Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
8 Total Patients Enrolled