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Kinase Inhibitor

PDR001 for Colorectal Cancer

Phase 2
Waitlist Available
Led By Ryan Corcoran, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization until the time of death, up to approximately 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat metastatic colorectal cancer with the BRAF V600E mutation. The drugs being tested are Dabrafenib, Trametinib, and PDR001.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization until the time of death, up to approximately 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization until the time of death, up to approximately 10 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
Number of participants with grade 3, 4 and 5 adverse events
Overall Response Rate
Secondary study objectives
Disease Control Rate
Duration of Response
Mechanisms of response and resistance to dabrafenib, trametinib, and PDR001
+2 more

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739
73%
Diarrhoea
48%
Aspartate aminotransferase increased
43%
Alanine aminotransferase increased
27%
Decreased appetite
23%
Nausea
20%
Blood bilirubin increased
20%
Pyrexia
19%
Vomiting
19%
Fatigue
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%
Hyponatraemia
5%
Dry skin
5%
Rash
5%
Hypertension
4%
Dysgeusia
4%
Nasopharyngitis
4%
Procedural pain
4%
Productive cough
4%
Platelet count decreased
3%
Arthralgia
3%
Blood creatine phosphokinase increased
3%
Chills
3%
Anxiety
3%
Hyperlipasaemia
3%
Myalgia
3%
Dysphagia
3%
Dry mouth
3%
Rhinitis
3%
Blood creatinine increased
3%
Hyperglycaemia
3%
Gastrooesophageal reflux disease
3%
Hypokalaemia
3%
Haemoptysis
3%
Hepatic pain
2%
Upper gastrointestinal haemorrhage
2%
Dizziness
2%
Epistaxis
2%
Hypertriglyceridaemia
2%
Stomatitis
2%
Jaundice
2%
Dyspepsia
2%
Melaena
2%
Hyperkalaemia
2%
Bronchitis
2%
Pleural effusion
2%
Oesophageal varices haemorrhage
2%
Haematemesis
2%
Peripheral swelling
2%
Hyperbilirubinaemia
2%
Night sweats
2%
Abdominal discomfort
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%
Depression
1%
Palpitations
1%
Paraparesis
1%
Groin pain
1%
Gastrointestinal haemorrhage
1%
Haemorrhoids
1%
Folliculitis
1%
Vertigo
1%
Hypoglycaemia
1%
Gastritis
1%
Lymphopenia
1%
Oesophageal stenosis
1%
Haemorrhoidal haemorrhage
1%
Dyspnoea exertional
1%
Tumour associated fever
1%
Pneumonitis
1%
Venous thrombosis
1%
Hypovolaemic shock
1%
Peripheral sensory neuropathy
1%
Cholangitis
1%
Spinal cord compression
1%
Varices oesophageal
1%
Spinal pain
1%
Biloma
1%
Herpes zoster
1%
Calculus urinary
1%
Atelectasis
1%
Thrombocytopenia
1%
Animal bite
1%
Hepatic function abnormal
1%
Bone contusion
1%
Malnutrition
1%
Sleep disorder
1%
Gastric varices
1%
Gait disturbance
1%
Abdominal tenderness
1%
Hypomagnesaemia
1%
Confusional state
1%
Gastroenteritis
1%
Blood albumin decreased
1%
Pulmonary embolism
1%
Gastrointestinal sounds abnormal
1%
Duodenal obstruction
1%
Sinusitis
1%
Bilirubin conjugated increased
1%
Female genital tract fistula
1%
Bronchostenosis
1%
Prothrombin time prolonged
1%
Cancer pain
1%
Rash pustular
1%
Oesophageal ulcer
1%
Hyperuricaemia
1%
Tumour thrombosis
1%
Hepatomegaly
1%
Hepatic cirrhosis
1%
Hepatorenal syndrome
1%
General physical health deterioration
1%
Hernia
1%
Acute coronary syndrome
1%
Coronary artery disease
1%
Cholestasis
1%
Hepatic haematoma
1%
Pyelonephritis acute
1%
Varicella
1%
Carotid artery stenosis
1%
Cerebrovascular accident
1%
Dysarthria
1%
Haemorrhage intracranial
1%
Paraesthesia
1%
Paraplegia
1%
Urinary retention
1%
Aneurysm
1%
Bleeding varicose vein
1%
Hyperglobulinaemia
1%
Hyperthyroidism
1%
Angular cheilitis
1%
Toothache
1%
Chest discomfort
1%
Jaundice cholestatic
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%
Varicocele
1%
Rash macular
1%
Rash maculo-papular
1%
Haematoma
1%
Hot flush
1%
Multiple organ dysfunction syndrome
1%
Lung infection
1%
Liver carcinoma ruptured
1%
Acute kidney injury
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

1Treatment groups
Experimental Treatment
Group I: PDR001, Dabrafenib, TrametinibExperimental Treatment3 Interventions
Patients who fulfill eligibility criteria will be entered into the trial to receive PDR001, Dabrafenib, Trametinib. Treatment will be administered on an outpatient basis. After the screening procedures confirm participation in the research study: * Dabrafenib will be taken twice a day for 28 consecutive days * Trametinib will be taken once a day for 28 consecutive days * PDR001 will be administered IV every 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~4120
Trametinib
2014
Completed Phase 2
~1630
PDR001
2016
Completed Phase 2
~2890

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,257 Total Patients Enrolled
NovartisIndustry Sponsor
1,635 Previous Clinical Trials
2,731,074 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,078 Total Patients Enrolled
~4 spots leftby Nov 2025
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