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Kinase Inhibitor

encorafenib for Melanoma (QUAD01 Trial)

Phase 1 & 2

Waitlist Available

Led By Jason J Luke, MD

Research Sponsored by Jason J. Luke, MD

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 up to 36 months

Awards & highlights

QUAD01 Trial Summary

This trial is testing a combination of three or four drugs to see if they are more effective at treating melanoma than two drugs. The three drugs are a BRAF inhibitor, a MEK inhibitor, and a immunotherapy drug. The fourth drug is another immunotherapy drug.

QUAD01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recommended phase II dose (RP2D) of encorafenib + binimetinib +nivolumab + ipilimumab

Ipilimumab

Secondary outcome measures

Adverse Events at least probably related to treatment

Central Nervous System (CNS) Clinical Benefit Rate (CBR)

Progression-free survival (PFS)

+1 more

Side effects data

From 2023 Phase 2 trial • 95 Patients • NCT03693170

67%

Diarrhoea

44%

Nausea

40%

Rash

40%

Dermatitis acneiform

36%

Vomiting

33%

Abdominal pain

32%

Asthenia

32%

Dry skin

26%

Constipation

24%

Anaemia

23%

Decreased appetite

19%

Fatigue

16%

Dyspnoea

14%

Vision blurred

13%

Pyrexia

13%

Dysgeusia

13%

Lipase increased

13%

Pruritus

12%

Skin fissures

12%

Paronychia

11%

Amylase increased

11%

Headache

Back pain

Blood creatinine increased

Stomatitis

Arthralgia

Cough

Dyspepsia

Abdominal pain upper

Hypoalbuminaemia

Rectal haemorrhage

Weight decreased

Large intestinal obstruction

Abdominal discomfort

Dysphonia

Myalgia

Hypertrichosis

Hypomagnesaemia

Mucosal inflammation

Acute kidney injury

Intestinal obstruction

Insomnia

Muscle spasms

Palmar-plantar erythrodysaesthesia syndrome

Blood creatine phosphokinase increased

Erythema

Flatulence

Hyperkalaemia

Small intestinal obstruction

Renal failure

Lower gastrointestinal haemorrhage

Respiratory tract infection

Biliary tract infection

Escherichia sepsis

Cellulitis

Lymph node tuberculosis

Respiratory failure

Diverticulum

Enteritis

Enterocolitis

Intra-abdominal fluid collection

Large intestine perforation

Sepsis

Urinary tract infection

Diversion colitis

Femoral neck fracture

Infusion related reaction

Lumbar vertebral fracture

Cardiac failure

Myocardial infarction

Myocarditis

Pancreatitis acute

Subileus

General physical health deterioration

Bile duct stenosis

Cholangitis

Cholecystitis

Hepatic function abnormal

Appendicitis

Bacteraemia

Streptococcal bacteraemia

Tuberculosis

Detachment of retinal pigment epithelium

Alanine aminotransferase increased

Aspartate aminotransferase increased

Blood bilirubin increased

Gamma-glutamyltransferase increased

Hypokalaemia

Tumour associated fever

Dizziness

Haematuria

Nephritis

Nephrolithiasis

Pleural effusion

Pneumonia aspiration

Pneumonitis

100%

80%

60%

40%

20%

Study treatment Arm

1 Arm

QUAD01 Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 1 (cohort 2): 450mg encorafenib + 45mg binimetinib + 3mg/kg nivolumab + 1mg/kg ipilimumabExperimental Treatment4 Interventions

Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).

Group II: Phase 1 (cohort 1): 300mg encorafenib + 3mg/kg nivolumab + 1 mg/kg ipilimumabExperimental Treatment3 Interventions

Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

binimetinib

2017

Completed Phase 2

~80

nivolumab

2016

Completed Phase 3

~4960

ipilimumab

2016

Completed Phase 3

~5520

encorafenib

2019

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jason J. Luke, MDLead Sponsor

4 Previous Clinical Trials

714 Total Patients Enrolled

3 Trials studying Melanoma

698 Patients Enrolled for Melanoma

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,512 Total Patients Enrolled

177 Trials studying Melanoma

57,541 Patients Enrolled for Melanoma

Jason J Luke, MDPrincipal InvestigatorUPMC Hillman Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the focus of this research?

"The aim of this study is to find the recommended phase II dose (RP2D) of encorafenib + binimetinib +nivolumab + ipilimumab, which will be evaluated over a 12-month period. Secondary objectives include assessing the response rate per RECIST v1.1 criteria (defined as complete response [CR] + partial response [PR]) and the central nervous system clinical benefit rate (CBR) (defined as complete response [CR] + partial response [PR] + stable disease [SD] >6 months). Other measures include adverse events that are possibly,"

Answered by AI

How many individuals are being given this treatment as part of the research study?

"Yes, an update on clinicaltrials.gov today shows that the research team is still looking for willing participants. This study was originally posted on May 8th, 2021 and was last updated March 24th, 2022. They are recruiting 84 individuals from a single location."

Answered by AI

Encorafenib is often taken as a treatment for what?

"encorafenib can be used to treat patients that have undergone anti-angiogenic therapy in the past. It is also an effective treatment for malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Are investigators looking for more participants in this experiment?

"According to the most recent update on clinicaltrials.gov, this clinical trial is still recruiting patients. The posting went up on 5/28/2021 and was edited for accuracy on 3/24/2022."

Answered by AI

Are there any other drugs that have been studied in conjunction with encorafenib?

"As of now, 846 different clinical studies are investigating encorafenib with 89 trials in the third phase. The majority of these encorafenib clinical trials originate from Pittsburgh, Pennsylvania; however, 44960 locations total are running encorafenib trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma

Jason J. Luke, MD 2021. "Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04655157.