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Kinase Inhibitor
LY3022855 + BRAF/MEK Inhibitors for Melanoma
Phase 1 & 2
Waitlist Available
Led By Elizabeth Buchbinder, MD
Research Sponsored by Dana-Farber Cancer Institute
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 2 years
Awards & highlights
Study Summary
This trial is studying a combination of targeted therapies to see if they are effective in treating advanced melanoma that has a BRAF V600E or BRAF V600K genetic mutation.
Who is the study for?
Adults with advanced melanoma and a specific BRAF V600E or K mutation can join this trial. They must not have had prior BRAF/MEK inhibitor therapy, should have measurable disease, normal organ/marrow function, good heart health (LVEF ≥ 50%), and available tumor tissue. Participants need to use contraception and sign consent. Exclusions include recent other cancer treatments, unresolved treatment side effects, certain allergies or illnesses, pregnancy, HIV history, QT syndrome family history, brain metastases.Check my eligibility
What is being tested?
The study is testing the effectiveness of LY3022855 combined with two targeted therapies—Vemurafenib and Cobimetinib—in treating advanced melanoma with specific genetic mutations. The trial has two parts: phase I for those without standard treatment options left and phase II for those who haven't received previous BRAF/MEK inhibitors.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the drugs used in the study (LY3022855/Vemurafenib/Cobimetinib), issues from drug interactions affecting liver enzymes (CYP3A), heart rhythm problems due to long QT syndrome risk factors in participants' medical or family history.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Secondary outcome measures
Complete response
Overall Response Rate
Overall Survival
+4 moreSide effects data
From 2018 Phase 1 trial • 72 Patients • NCT0271891160%
Face oedema
60%
Blood creatine phosphokinase increased
60%
Fatigue
60%
Pruritus
40%
Musculoskeletal pain
40%
Rash maculo-papular
40%
Diarrhoea
40%
Hypothyroidism
40%
Stomatitis
40%
Oedema peripheral
40%
Cough
40%
Aspartate aminotransferase increased
40%
Dyspnoea
40%
Insomnia
40%
Decreased appetite
20%
Dry mouth
20%
Constipation
20%
Palpitations
20%
Oral candidiasis
20%
Catheter site pain
20%
Lip blister
20%
Catheter site inflammation
20%
Chills
20%
Nasal congestion
20%
Rectal haemorrhage
20%
Pyrexia
20%
White blood cells urine positive
20%
Weight increased
20%
Haematuria
20%
Rash
20%
Blood creatinine increased
20%
Skin infection
20%
Upper-airway cough syndrome
20%
Dry eye
20%
Eye swelling
20%
Lip pain
20%
Rash macular
20%
Hyperthyroidism
20%
Urinary tract infection
20%
Wheezing
20%
Carpal tunnel syndrome
20%
Petechiae
20%
Atrial enlargement
20%
Left ventricular hypertrophy
20%
Bradycardia
20%
Periorbital oedema
20%
Vision blurred
20%
Lacrimation increased
20%
Hypoalbuminaemia
20%
Amylase increased
20%
Back pain
20%
Qrs axis abnormal
20%
Pleural effusion
20%
Contusion
20%
Anaemia
20%
Electrocardiogram abnormal
20%
Electrocardiogram repolarisation abnormality
20%
Rash pruritic
20%
Alanine aminotransferase increased
20%
Glomerular filtration rate decreased
20%
Blood lactate dehydrogenase increased
20%
Hypocalcaemia
20%
Hyponatraemia
20%
Bone pain
20%
Thrombophlebitis superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W)
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
Cohort B-1: NSCLC LY3022855+ Durvalumab
Cohort B-1: OVARIAN LY3022855+ Durvalumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: LY3022855 + Vemurafenib + CobimetinibExperimental Treatment3 Interventions
LY3022855 administered intravenously every week Vemurafenib administered by mouth twice daily Cobimetinib administered by mouth once daily on days 1-21of each cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3022855
2015
Completed Phase 1
~110
Vemurafenib
FDA approved
Cobimetinib
FDA approved
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,943 Total Patients Enrolled
32 Trials studying Melanoma
2,905 Patients Enrolled for Melanoma
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,555 Total Patients Enrolled
9 Trials studying Melanoma
1,193 Patients Enrolled for Melanoma
Elizabeth Buchbinder, MDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
43 Total Patients Enrolled
3 Trials studying Melanoma
43 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not fully recovered from side effects of previous cancer treatment.You have previously been treated with a BRAF or MEK inhibitor.Your heart's pumping function (LVEF) must be at least 50%.You have a confirmed diagnosis of melanoma with specific gene mutations, and you have not been treated with certain medications before.If you want to join the second part of the study, you need to have a way for the doctors to measure the disease.You are able to perform daily activities without any major issues or with some minor limitations.Your organs and bone marrow must be working normally.You are taking certain medications that can interact with the study drug.You need to have a sample of your tumor tissue from a previous test.You have had allergic reactions to similar drugs as LY3022855, vemurafenib, or cobimetinib.You have been diagnosed with HIV.You or someone in your family has a history of long QT syndrome.You are taking strong or moderate CYP3A inducer medications.You have a problem with your eyes found during an eye exam.You cannot swallow or keep down pills.You have brain tumors that have not been treated yet.You have had another type of cancer in the past.You have a stomach or intestinal condition that could affect how your body absorbs vemurafenib and cobimetinib.You have advanced melanoma with a specific genetic mutation, and standard treatments are not working for you.Participants joining the first part of the trial must have a way for doctors to measure their disease.Your heart's electrical activity, measured on a heart test, should be below a certain number.
Research Study Groups:
This trial has the following groups:- Group 1: LY3022855 + Vemurafenib + Cobimetinib
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Are there any precedent studies that have employed LY3022855?
"Currently, there are 75 investigations for the efficacy of LY3022855 with 4 studies in the final phase. Most trials involving this drug occur in Shizuoka and New South Wales but it is available at over two thousand sites globally."
Answered by AI
What is the primary application of LY3022855 as a therapeutic agent?
"Patients suffering from metastatic melanoma, non-small cell lung carcinoma, or unresectable melanoma can benefit from LY3022855 as a form of treatment."
Answered by AI
Is there still an opportunity for participants to join this experiment?
"Clinicaltrials.gov reveals that this medical trial is not presently recruiting participants, despite having been originally posted on June 6th 2017 and recently updated July 26th 2022. Fortunately, there are 829 other studies currently enrolling patients."
Answered by AI
How many participants are enrolled in this research venture?
"Unfortunately, this medical trial is no longer recruiting. It was initially posted on 6th June 2017 and last updated on 26 July 2022. If you are still looking for studies related to melanoma, there are currently 754 active trials enrolling patients with that condition, as well as 75 specifically for LY3022855."
Answered by AI
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