CLINICAL TRIAL

BVD-523 for Melanoma

Locally Advanced
Metastatic
Waitlist Available · 18+ · All Sexes · Boston, MA

This study is evaluating whether a targeted therapy called BVD-523 is effective in treating advanced uveal melanoma.

See full description

About the trial for Melanoma

Eligible Conditions
Uveal Neoplasms · Melanoma, Uveal · Melanoma

Treatment Groups

This trial involves 2 different treatments. BVD-523 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
BVD-523
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ulixertinib
Not yet FDA approved

Side Effect Profile for Dose-escalation 10mg b.i.d. Cohort

Dose-escalation 10mg b.i.d. Cohort
Show all side effects
100%
DIARRHOEA
100%
DRY SKIN
100%
HOT FLUSH
100%
FLANK PAIN
100%
MYALGIA
100%
ORAL PAIN
100%
ALOPECIA
100%
NAUSEA
100%
SINUS OPERATION
100%
ARTHRALGIA
100%
NECK PAIN
100%
RASH MACULO-PAPULAR
100%
MUSCULOSKELETAL DISCOMFORT
100%
URINARY TRACT INFECTION
100%
PALPITATIONS
100%
NAIL GROWTH ABNORMAL
100%
OCCULT BLOOD POSITIVE
100%
MUSCLE TIGHTNESS
100%
MUSCLE SPASMS
100%
TENSION HEADACHE
100%
DERMATITIS ACNEIFORM
100%
EYE CONTUSION
0%
MENTAL STATUS CHANGES
0%
DYSPHAGIA
0%
HYPERKALAEMIA
0%
OROPHARYNGEAL PAIN
0%
HYPERTENSION
0%
ATAXIA
0%
SKIN INFECTION
0%
BLEPHARITIS
0%
ABDOMINAL PAIN
0%
BRONCHITIS
0%
ANXIETY
0%
CARDIAC ARREST
0%
WOUND HAEMORRHAGE
0%
HYPOTENSION
0%
CHOLANGITIS
0%
CONFUSIONAL STATE
0%
DRY MOUTH
0%
DIZZINESS
0%
RASH ERYTHEMATOUS
0%
DECUBITUS ULCER
0%
ERYTHEMA
0%
MACULE
0%
SKIN LESION
0%
BLOOD PHOSPHORUS INCREASED
0%
LARGE INTESTINAL OBSTRUCTION
0%
PAINFUL DEFAECATION
0%
PRODUCTIVE COUGH
0%
LIP INJURY
0%
LACERATION
0%
DYSURIA
0%
INFLUENZA
0%
FALL
0%
ABDOMINAL DISTENSION
0%
MUSCULOSKELETAL PAIN
0%
CEREBELLAR INFARCTION
0%
THIRST
0%
GASTROENTERITIS VIRAL
0%
CEREBRAL HAEMORRHAGE
0%
CHEST PAIN
0%
BLOOD ALKALINE PHOSPHATASE INCREASED
0%
PROTEIN TOTAL DECREASED
0%
FRACTURE
0%
HYPOVOLAEMIC SHOCK
0%
GALLBLADDER OBSTRUCTION
0%
CARDIAC NEOPLASM UNSPECIFIED
0%
SPINAL FRACTURE
0%
HYPERGLYCAEMIA
0%
ACTINIC KERATOSIS
0%
HAEMOPTYSIS
0%
ONYCHOMYCOSIS
0%
LETHARGY
0%
MUSCLE TWITCHING
0%
MYDRIASIS
0%
RECTAL CANCER
0%
LEUKOCYTOSIS
0%
DYSPNOEA EXERTIONAL
0%
URTICARIA
0%
BLOOD BILIRUBIN INCREASED
0%
INSOMNIA
0%
PATHOLOGICAL FRACTURE
0%
OEDEMA PERIPHERAL
0%
SWELLING FACE
0%
UROSEPSIS
0%
MUSCULOSKELETAL CHEST PAIN
0%
DISEASE PROGRESSION
0%
PULMONARY EMBOLISM
0%
BACK PAIN
0%
FACTOR VIII INHIBITION
0%
CHEST DISCOMFORT
0%
AGITATION
0%
FLATULENCE
0%
FOLLICULITIS
0%
NAIL INFECTION
0%
RESPIRATORY TRACT INFECTION
0%
SYNCOPE
0%
CONVULSION
0%
GASTRIC ULCER
0%
RENAL FAILURE ACUTE
0%
ASTHENIA
0%
MUCOSAL INFLAMMATION
0%
ALANINE AMINOTRANSFERASE INCREASED
0%
BLOOD CREATININE INCREASED
0%
HYPOALBUMINAEMIA
0%
BACTERIAL SEPSIS
0%
RESPIRATORY TRACT INFECTION VIRAL
0%
CEREBROVASCULAR ACCIDENT
0%
PETIT MAL EPILEPSY
0%
DELIRIUM
0%
PAIN
0%
DEHYDRATION
0%
VOMITING
0%
MELAENA
0%
URINARY INCONTINENCE
0%
PYREXIA
0%
OPTIC NERVE DISORDER
0%
UPPER RESPIRATORY TRACT INFECTION
0%
SOMNOLENCE
0%
NAIL BED DISORDER
0%
ADRENAL INSUFFICIENCY
0%
LIVER FUNCTION TEST ABNORMAL
0%
PNEUMOTHORAX
0%
DEATH
0%
BACTERAEMIA
0%
LOWER GASTROINTESTINAL HAEMORRHAGE
0%
ORAL CANDIDIASIS
0%
ORAL HERPES
0%
ELECTROLYTE IMBALANCE
0%
ATRIAL FIBRILLATION
0%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0%
TOXICITY TO VARIOUS AGENTS
0%
STRIDOR
0%
COUGH
0%
PLEURAL EFFUSION
0%
PRURITUS
0%
DIVERTICULUM
0%
PERITONEAL DISORDER
0%
RASH MACULAR
0%
EPISTAXIS
0%
PNEUMONIA
0%
BODY TEMPERATURE INCREASED
0%
PAIN IN EXTREMITY
0%
DEEP VEIN THROMBOSIS
0%
INCISION SITE COMPLICATION
0%
KERATOACANTHOMA
0%
ERECTILE DYSFUNCTION
0%
TUMOUR PAIN
0%
HYPONATRAEMIA
0%
INTESTINAL OBSTRUCTION
0%
TACHYCARDIA
0%
UPPER GASTROINTESTINAL HAEMORRHAGE
0%
HIRSUTISM
0%
MALAISE
0%
PLATELET COUNT DECREASED
0%
VULVOVAGINAL ERYTHEMA
0%
GASTROOESOPHAGEAL REFLUX DISEASE
0%
HYPOKALAEMIA
0%
RASH
0%
HAEMATURIA
0%
ABDOMINAL DISCOMFORT
0%
ABDOMINAL PAIN LOWER
0%
SMALL INTESTINAL OBSTRUCTION
0%
PERITONITIS BACTERIAL
0%
SINUSITIS
0%
HYPOAESTHESIA
0%
PHOTOPHOBIA
0%
SEASONAL ALLERGY
0%
LARGE INTESTINAL ULCER
0%
PROTEINURIA
0%
PERICARDIAL EFFUSION
0%
THROMBOSIS
0%
OESOPHAGITIS
0%
FATIGUE
0%
CELLULITIS
0%
THROMBOCYTOPENIA
0%
CHOLECYSTITIS
0%
LIPASE INCREASED
0%
PANCREATITIS ACUTE
0%
VISUAL IMPAIRMENT
0%
CONSTIPATION
0%
HEADACHE
0%
RHINORRHOEA
0%
RASH PRURITIC
0%
KIDNEY INFECTION
0%
VIRAL UPPER RESPIRATORY TRACT INFECTION
0%
HYDRONEPHROSIS
0%
FUNGAEMIA
0%
PNEUMONITIS
0%
THROMBOTIC THROMBOCYTOPENIC PURPURA
0%
CARDIAC FAILURE
0%
HEMIPARESIS
0%
WEIGHT DECREASED
0%
DYSGEUSIA
0%
DYSPNOEA
0%
ANAL FISSURE
0%
HICCUPS
0%
CHALAZION
0%
EYE DISCHARGE
0%
CHORIORETINOPATHY
0%
SEBORRHOEIC KERATOSIS
0%
OVERDOSE
0%
STOMATITIS
0%
LYMPHOCYTE COUNT DECREASED
0%
EXCORIATION
0%
RENAL FAILURE
0%
HYPERBILIRUBINAEMIA
0%
PANCREATITIS
0%
JOINT SWELLING
0%
LYMPHOPENIA
0%
CONDUCTION DISORDER
0%
VIRAL INFECTION
0%
MUSCULAR WEAKNESS
0%
GASTROINTESTINAL HAEMORRHAGE
0%
HYPOGLYCAEMIA
0%
ABDOMINAL PAIN UPPER
0%
PERITONEAL HAEMORRHAGE
0%
ANAEMIA
0%
JAUNDICE
0%
ESCHERICHIA BACTERAEMIA
0%
VISION BLURRED
0%
CHILLS
0%
HYPOCALCAEMIA
0%
HYPOMAGNESAEMIA
0%
ASCITES
0%
ERYTHEMA MULTIFORME
0%
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
0%
APPLICATION SITE RASH
0%
NASAL CONGESTION
0%
CHEILITIS
0%
SEPSIS
0%
RETROPERITONEAL HAEMORRHAGE
0%
RETINAL VEIN OCCLUSION
0%
ASPARTATE AMINOTRANSFERASE INCREASED
0%
DECREASED APPETITE
0%
GINGIVAL BLEEDING
0%
ACNE
0%
PHOTOSENSITIVITY REACTION
0%
THROAT IRRITATION
0%
CANDIDIASIS
0%
STAPHYLOCOCCAL INFECTION
0%
ABNORMAL SENSATION IN EYE
0%
PARAESTHESIA
0%
UPPER LIMB FRACTURE
DIARRHOEA
100%
DRY SKIN
100%
HOT FLUSH
100%
FLANK PAIN
100%
MYALGIA
100%
ORAL PAIN
100%
ALOPECIA
100%
NAUSEA
100%
SINUS OPERATION
100%
ARTHRALGIA
100%
NECK PAIN
100%
RASH MACULO-PAPULAR
100%
MUSCULOSKELETAL DISCOMFORT
100%
URINARY TRACT INFECTION
100%
PALPITATIONS
100%
NAIL GROWTH ABNORMAL
100%
OCCULT BLOOD POSITIVE
100%
MUSCLE TIGHTNESS
100%
MUSCLE SPASMS
100%
TENSION HEADACHE
100%
DERMATITIS ACNEIFORM
100%
EYE CONTUSION
100%
MENTAL STATUS CHANGES
0%
DYSPHAGIA
0%
HYPERKALAEMIA
0%
OROPHARYNGEAL PAIN
0%
HYPERTENSION
0%
ATAXIA
0%
SKIN INFECTION
0%
BLEPHARITIS
0%
ABDOMINAL PAIN
0%
BRONCHITIS
0%
ANXIETY
0%
CARDIAC ARREST
0%
WOUND HAEMORRHAGE
0%
HYPOTENSION
0%
CHOLANGITIS
0%
CONFUSIONAL STATE
0%
DRY MOUTH
0%
DIZZINESS
0%
RASH ERYTHEMATOUS
0%
DECUBITUS ULCER
0%
ERYTHEMA
0%
MACULE
0%
SKIN LESION
0%
BLOOD PHOSPHORUS INCREASED
0%
LARGE INTESTINAL OBSTRUCTION
0%
PAINFUL DEFAECATION
0%
PRODUCTIVE COUGH
0%
LIP INJURY
0%
LACERATION
0%
DYSURIA
0%
INFLUENZA
0%
FALL
0%
ABDOMINAL DISTENSION
0%
MUSCULOSKELETAL PAIN
0%
CEREBELLAR INFARCTION
0%
THIRST
0%
GASTROENTERITIS VIRAL
0%
CEREBRAL HAEMORRHAGE
0%
CHEST PAIN
0%
BLOOD ALKALINE PHOSPHATASE INCREASED
0%
PROTEIN TOTAL DECREASED
0%
FRACTURE
0%
HYPOVOLAEMIC SHOCK
0%
GALLBLADDER OBSTRUCTION
0%
CARDIAC NEOPLASM UNSPECIFIED
0%
SPINAL FRACTURE
0%
HYPERGLYCAEMIA
0%
ACTINIC KERATOSIS
0%
HAEMOPTYSIS
0%
ONYCHOMYCOSIS
0%
LETHARGY
0%
MUSCLE TWITCHING
0%
MYDRIASIS
0%
RECTAL CANCER
0%
LEUKOCYTOSIS
0%
DYSPNOEA EXERTIONAL
0%
URTICARIA
0%
BLOOD BILIRUBIN INCREASED
0%
INSOMNIA
0%
PATHOLOGICAL FRACTURE
0%
OEDEMA PERIPHERAL
0%
SWELLING FACE
0%
UROSEPSIS
0%
MUSCULOSKELETAL CHEST PAIN
0%
DISEASE PROGRESSION
0%
PULMONARY EMBOLISM
0%
BACK PAIN
0%
FACTOR VIII INHIBITION
0%
CHEST DISCOMFORT
0%
AGITATION
0%
FLATULENCE
0%
FOLLICULITIS
0%
NAIL INFECTION
0%
RESPIRATORY TRACT INFECTION
0%
SYNCOPE
0%
CONVULSION
0%
GASTRIC ULCER
0%
RENAL FAILURE ACUTE
0%
ASTHENIA
0%
MUCOSAL INFLAMMATION
0%
ALANINE AMINOTRANSFERASE INCREASED
0%
BLOOD CREATININE INCREASED
0%
HYPOALBUMINAEMIA
0%
BACTERIAL SEPSIS
0%
RESPIRATORY TRACT INFECTION VIRAL
0%
CEREBROVASCULAR ACCIDENT
0%
PETIT MAL EPILEPSY
0%
DELIRIUM
0%
PAIN
0%
DEHYDRATION
0%
VOMITING
0%
MELAENA
0%
URINARY INCONTINENCE
0%
PYREXIA
0%
OPTIC NERVE DISORDER
0%
UPPER RESPIRATORY TRACT INFECTION
0%
SOMNOLENCE
0%
NAIL BED DISORDER
0%
ADRENAL INSUFFICIENCY
0%
LIVER FUNCTION TEST ABNORMAL
0%
PNEUMOTHORAX
0%
DEATH
0%
BACTERAEMIA
0%
LOWER GASTROINTESTINAL HAEMORRHAGE
0%
ORAL CANDIDIASIS
0%
ORAL HERPES
0%
ELECTROLYTE IMBALANCE
0%
ATRIAL FIBRILLATION
0%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0%
TOXICITY TO VARIOUS AGENTS
0%
STRIDOR
0%
COUGH
0%
PLEURAL EFFUSION
0%
PRURITUS
0%
DIVERTICULUM
0%
PERITONEAL DISORDER
0%
RASH MACULAR
0%
EPISTAXIS
0%
PNEUMONIA
0%
BODY TEMPERATURE INCREASED
0%
PAIN IN EXTREMITY
0%
DEEP VEIN THROMBOSIS
0%
INCISION SITE COMPLICATION
0%
KERATOACANTHOMA
0%
ERECTILE DYSFUNCTION
0%
TUMOUR PAIN
0%
HYPONATRAEMIA
0%
INTESTINAL OBSTRUCTION
0%
TACHYCARDIA
0%
UPPER GASTROINTESTINAL HAEMORRHAGE
0%
HIRSUTISM
0%
MALAISE
0%
PLATELET COUNT DECREASED
0%
VULVOVAGINAL ERYTHEMA
0%
GASTROOESOPHAGEAL REFLUX DISEASE
0%
HYPOKALAEMIA
0%
RASH
0%
HAEMATURIA
0%
ABDOMINAL DISCOMFORT
0%
ABDOMINAL PAIN LOWER
0%
SMALL INTESTINAL OBSTRUCTION
0%
PERITONITIS BACTERIAL
0%
SINUSITIS
0%
HYPOAESTHESIA
0%
PHOTOPHOBIA
0%
SEASONAL ALLERGY
0%
LARGE INTESTINAL ULCER
0%
PROTEINURIA
0%
PERICARDIAL EFFUSION
0%
THROMBOSIS
0%
OESOPHAGITIS
0%
FATIGUE
0%
CELLULITIS
0%
THROMBOCYTOPENIA
0%
CHOLECYSTITIS
0%
LIPASE INCREASED
0%
PANCREATITIS ACUTE
0%
VISUAL IMPAIRMENT
0%
CONSTIPATION
0%
HEADACHE
0%
RHINORRHOEA
0%
RASH PRURITIC
0%
KIDNEY INFECTION
0%
VIRAL UPPER RESPIRATORY TRACT INFECTION
0%
HYDRONEPHROSIS
0%
FUNGAEMIA
0%
PNEUMONITIS
0%
THROMBOTIC THROMBOCYTOPENIC PURPURA
0%
CARDIAC FAILURE
0%
HEMIPARESIS
0%
WEIGHT DECREASED
0%
DYSGEUSIA
0%
DYSPNOEA
0%
ANAL FISSURE
0%
HICCUPS
0%
CHALAZION
0%
EYE DISCHARGE
0%
CHORIORETINOPATHY
0%
SEBORRHOEIC KERATOSIS
0%
OVERDOSE
0%
STOMATITIS
0%
LYMPHOCYTE COUNT DECREASED
0%
EXCORIATION
0%
RENAL FAILURE
0%
HYPERBILIRUBINAEMIA
0%
PANCREATITIS
0%
JOINT SWELLING
0%
LYMPHOPENIA
0%
CONDUCTION DISORDER
0%
VIRAL INFECTION
0%
MUSCULAR WEAKNESS
0%
GASTROINTESTINAL HAEMORRHAGE
0%
HYPOGLYCAEMIA
0%
ABDOMINAL PAIN UPPER
0%
PERITONEAL HAEMORRHAGE
0%
ANAEMIA
0%
JAUNDICE
0%
ESCHERICHIA BACTERAEMIA
0%
VISION BLURRED
0%
CHILLS
0%
HYPOCALCAEMIA
0%
HYPOMAGNESAEMIA
0%
ASCITES
0%
ERYTHEMA MULTIFORME
0%
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
0%
APPLICATION SITE RASH
0%
NASAL CONGESTION
0%
CHEILITIS
0%
SEPSIS
0%
RETROPERITONEAL HAEMORRHAGE
0%
RETINAL VEIN OCCLUSION
0%
ASPARTATE AMINOTRANSFERASE INCREASED
0%
DECREASED APPETITE
0%
GINGIVAL BLEEDING
0%
ACNE
0%
PHOTOSENSITIVITY REACTION
0%
THROAT IRRITATION
0%
CANDIDIASIS
0%
STAPHYLOCOCCAL INFECTION
0%
ABNORMAL SENSATION IN EYE
0%
PARAESTHESIA
0%
UPPER LIMB FRACTURE
0%
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT01781429) in the Dose-escalation 10mg b.i.d. Cohort ARM group. Side effects include: DIARRHOEA with 100%, DRY SKIN with 100%, HOT FLUSH with 100%, FLANK PAIN with 100%, MYALGIA with 100%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 18 years or older. show original
The patient has an ECOG performance status of ≤2, meaning that they have a Karnofsky score of ≥60%. show original
Patients with uveal melanoma can have received any number of treatments excluding prior treatment with an ERK inhibitor show original
that is not amenable to curative treatment with surgery Participants must have uveal melanoma that has spread to other parts of the body and is not treatable with surgery. show original
Participants must have a measurable disease, which is defined as having at least one lesion that is 20 mm or longer when measured using conventional techniques, or 10 mm or longer when using spiral CT scan, MRI, or calipers by clinical exam show original
The patient is expected to live for more than 6 months. show original
leukocytes ≥3,000/mcL
hemoglobin ≥9.0 g/dL
This means that the absolute neutrophil count is greater than or equal to 1,500/mcL. show original
A person's platelets are at least 100,000 per microliter. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether BVD-523 will improve 1 primary outcome and 9 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Between the dates of the start of trial treatment and first documentation of progressive disease. In the absence of documented progressive disease, follow-up will be censored at date of last disease assessment. up to 52 weeks.

Median Time to Tumor Progression
BETWEEN THE DATES OF THE START OF TRIAL TREATMENT AND FIRST DOCUMENTATION OF PROGRESSIVE DISEASE. IN THE ABSENCE OF DOCUMENTED PROGRESSIVE DISEASE, FOLLOW-UP WILL BE CENSORED AT DATE OF LAST DISEASE ASSESSMENT. UP TO 52 WEEKS
Time from enrollment on study until the tumor is progressing by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
BETWEEN THE DATES OF THE START OF TRIAL TREATMENT AND FIRST DOCUMENTATION OF PROGRESSIVE DISEASE. IN THE ABSENCE OF DOCUMENTED PROGRESSIVE DISEASE, FOLLOW-UP WILL BE CENSORED AT DATE OF LAST DISEASE ASSESSMENT. UP TO 52 WEEKS
Disease Control Rate
UP TO 52 WEEKS
A combination of patients who experience complete response, partial response and stable disease on CT or other form of imaging
UP TO 52 WEEKS
Overall Response Rate
UP TO 52 WEEKS
Overall Response Rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
UP TO 52 WEEKS
To Evaluate the Pharmacodynamics of ERK Inhibition on BVD-523 With a Comparison of Pre- and On-treatment Biopsies.
TUMOR BIOPSIES ARE OBTAINED 7-28 DAYS PRIOR TO THE FIRST TREATMENT AND 12-16 DAYS FOLLOWING THE INITIAL TREATMENT IN ORDER TO FACILITATE ERK SIGNALING ANALYSIS, MUTATION ANALYSIS, SEQUENCING, AND CELL LINE DEVELOPMENT.
MAPK pathway inhibition will be analyzed in pre-treatment and post-treatment samples to understand the effect of ERK inhibition by BVD-523
TUMOR BIOPSIES ARE OBTAINED 7-28 DAYS PRIOR TO THE FIRST TREATMENT AND 12-16 DAYS FOLLOWING THE INITIAL TREATMENT IN ORDER TO FACILITATE ERK SIGNALING ANALYSIS, MUTATION ANALYSIS, SEQUENCING, AND CELL LINE DEVELOPMENT.
To Better Understand the Genetic Variability of Uveal Melanoma Through Whole Exome Sequencing
TUMOR BIOPSIES ARE OBTAINED 7-28 DAYS PRIOR TO THE FIRST TREATMENT AND 12-16 DAYS FOLLOWING THE INITIAL TREATMENT IN ORDER TO FACILITATE ERK SIGNALING ANALYSIS, MUTATION ANALYSIS, SEQUENCING, AND CELL LINE DEVELOPMENT.
DNA sequencing will occur in tissue samples from patients treated on study to gain a better understanding of the genetic variability observed in uveal melanoma
TUMOR BIOPSIES ARE OBTAINED 7-28 DAYS PRIOR TO THE FIRST TREATMENT AND 12-16 DAYS FOLLOWING THE INITIAL TREATMENT IN ORDER TO FACILITATE ERK SIGNALING ANALYSIS, MUTATION ANALYSIS, SEQUENCING, AND CELL LINE DEVELOPMENT.
Median Overall Survival
PARTICIPANT SURVIVAL INFORMATION WILL BE COLLECTED EVERY 4 WEEKS FROM THE DATE OF LAST DOSE OF STUDY DRUG UNTIL THE PARTICIPANT'S DEATH OR UNTIL THE PARTICIPANT IS LOST TO FOLLOW-UP, OR UNTIL STUDY CLOSURE. MEDIAN FOLLOW-UP WAS 6 MONTHS.
OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
PARTICIPANT SURVIVAL INFORMATION WILL BE COLLECTED EVERY 4 WEEKS FROM THE DATE OF LAST DOSE OF STUDY DRUG UNTIL THE PARTICIPANT'S DEATH OR UNTIL THE PARTICIPANT IS LOST TO FOLLOW-UP, OR UNTIL STUDY CLOSURE. MEDIAN FOLLOW-UP WAS 6 MONTHS.
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Who is running the study

Principal Investigator
E. B.
Elizabeth Buchbinder, Principal Investigator
Dana-Farber Cancer Institute

Patient Q & A Section

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

What causes melanoma?

The cause of [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer) is complex and includes solar cell-generated ultraviolet rays, sun exposure, and lifestyle factors. Melanoma is a heterogeneous type of cancer, which has at least 14 distinct genetic and morphologic variants. Melanoma can arise spontaneously and from a broad spectrum of nevi. Sunscreen is the best prevention strategy for mitigating sun exposure, but melanoma also can be prevented by careful use of sunscreens with high UVA protection.

Anonymous Patient Answer

What are the signs of melanoma?

Melanosis is the most important sign for melanoma as it occurs on most of the skin. Other signs include: itch, ulceration, pain and swelling. Some forms of melanoma such as atypical and acral lentiginous melanoma can produce only a few of these symptoms. The most important aspect is if it is a persistent abnormality, such as red lesions which have never gone away or a new lesion. Tumours that are growing should be removed as soon as they are diagnosed. If a tumour is removed but the margins are not clear, they should hopefully be checked annually and surgery is not warranted. If a tumour is suspected but not diagnosed, then a biopsy should be performed.

Anonymous Patient Answer

How many people get melanoma a year in the United States?

The American Cancer Society estimates that 441,300 new cases of melanoma will be diagnosed in 2017 and 452,800 cases of melanoma will be diagnosed in 2022. The U.S. lifetime risk of developing melanoma is about 1.4%. Because melanomas are very difficult to detect prior to being symptomatic, and melanomas are very often symptomatic before detection, people who receive a diagnosis of melanoma must be vigilant and have a plan of surveillance for future [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer), regardless of type or localization of the initial cancer.

Anonymous Patient Answer

What are common treatments for melanoma?

The most common treatment for melanoma is surgical excision. Noninvasive techniques can have a significant impact on the cancer. However, for certain melanomas, such as those with a mole with minimal or no pigmentation at the time of surgery, these techniques may not always be effective. Radiation therapy can be used for inoperable melanomas, when surgery is not practical or the patient would not consider it, or if all treatment options are exhausted.

Anonymous Patient Answer

Can melanoma be cured?

Although melanoma is a highly curable disease, a cure is not possible. There is no cure for nonmelanoma skin cancer, and most skin cancers are curable by excision or treatment.

Anonymous Patient Answer

What is melanoma?

Although common, melanoma is not a fatal disease. Survival rates are improving across Europe, with better prognostic factors being identified. Improved methods of skin screening are now recommended by the English National Health Service.

Anonymous Patient Answer

What is the survival rate for melanoma?

Overall survival is good, with an average survival rate of about 24 months from the time of diagnosis of melanoma; however, the outlook of patients diagnosed with node-negative melanoma is often less favourable. The survival rate decreases with older age at presentation and with disease spread. As a general rule, the five-year survival rate of cutaneous melanoma does not differ significantly from that for non-cutaneous melanoma.

Anonymous Patient Answer

Does melanoma run in families?

Genetic linkage analysis has provided compelling empirical evidence in support of an autosomal dominant genetic basis for melanoma susceptibility in these families. Genetic markers associated with familial melanoma susceptibility include the MC1R and the CDKN2A genes.

Anonymous Patient Answer

Is bvd-523 typically used in combination with any other treatments?

BVD-523 was used in combination with all 3 treatments and the authors did not observe significant additional antitumor activity. BVD-523 was used in combination with all of the 2 treatments, and no additional antitumor activity was observed. BVD-523 was tested in combination with all 3 treatments, and there were no additional antitumor effects. As the activity of BVD-523 has no additive effects and the side effects in combination with all 3 treatments were tolerable, these results provide a starting point for further evaluation in a phase 1 trial of BVD-523 in patients with BRCA mutation carriers who have not responded to treatment. Further evaluation of BVD-523 is warranted.

Anonymous Patient Answer

How serious can melanoma be?

Melanoma is not unheard of, and for many patients can be a cause for great discomfort and concern. However, the incidence of melanoma is not as high as commonly thought and does not necessarily signify that a patient will have a more serious or dangerous diagnosis.

Anonymous Patient Answer

What does bvd-523 usually treat?

B-CD20 monoclonal antibody therapies have not led to a marked increase in the clinical use of melphalan as an induction agent compared to B-CD23 treatments alone for treatment of relapsed, refractory CD20 expressing B-cell malignancies. These preliminary findings are in agreement with the data from other oncology centers. We believe that further clinical studies need to demonstrate the benefit of including B-CD20 in induction regimens of CD20 targeted agents.

Anonymous Patient Answer

What is the primary cause of melanoma?

The main contributor of melanoma to the overall cancers burden is ultraviolet (UV) radiation from the sun. The most consistent and powerful risk factor for melanoma in developed countries is sun exposure over a long period of time such as on the beach, in the summer or at work. Although most people know about the benefits of avoiding UV exposure, people exposed to very high levels of UV radiation daily over a short period of time are at the highest risk for developing melanoma. Melanoma has a higher mortality rate than non-melanoma skin cancer and is the most costly cancer from treatment.

Anonymous Patient Answer
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