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Kinase Inhibitor

BVD-523 for Uveal Melanoma

Phase 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
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
Presence of metastatic disease that would be amenable to the required biopsies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Study Summary

This trial is testing a new drug to treat uveal melanoma that has spread.

Who is the study for?
This trial is for adults over 18 with stage IV uveal melanoma that can be measured, who've possibly had treatments before but not with an ERK inhibitor. They should have a life expectancy over 6 months, good organ function and heart health, and must be able to consent. Pregnant women or those on certain drugs affecting liver enzymes are excluded.Check my eligibility
What is being tested?
The study tests BVD-523 as a potential treatment for advanced uveal melanoma. It's focused on how well this targeted therapy works in patients who meet specific health criteria and haven't used similar treatments before.See study design
What are the potential side effects?
While the side effects of BVD-523 aren't listed here, common ones for cancer therapies include nausea, fatigue, risk of infection due to low blood counts, liver enzyme changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured.
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My cancer has spread and can be biopsied.
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My eye melanoma is confirmed to be at stage IV.
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My organ and bone marrow functions are normal.
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I have uveal melanoma and have not been treated with an ERK inhibitor.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate
Secondary outcome measures
Disease Control Rate
Median Overall Survival
Median Time to Tumor Progression
+2 more

Side effects data

From 2018 Phase 1 & 2 trial • 136 Patients • NCT01781429
100%
PALPITATIONS
100%
NAUSEA
100%
ORAL PAIN
100%
URINARY TRACT INFECTION
100%
ARTHRALGIA
100%
NECK PAIN
100%
DRY SKIN
100%
TENSION HEADACHE
100%
MUSCLE SPASMS
100%
MUSCLE TIGHTNESS
100%
HOT FLUSH
100%
SINUS OPERATION
100%
RASH MACULO-PAPULAR
100%
DIARRHOEA
100%
FLANK PAIN
100%
MYALGIA
100%
ALOPECIA
100%
DERMATITIS ACNEIFORM
100%
NAIL GROWTH ABNORMAL
100%
OCCULT BLOOD POSITIVE
100%
MUSCULOSKELETAL DISCOMFORT
100%
EYE CONTUSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose-escalation 10mg b.i.d. Cohort
Dose-escalation 20mg b.i.d. Cohort
Dose-escalation 40mg b.i.d. Cohort
Dose-escalation 75mg b.i.d. Cohort
Dose-escalation 150mg b.i.d. Cohort
Dose-escalation 300mg b.i.d. Cohort
Dose-escalation 600mg b.i.d. Cohort
Dose-escalation 750mg b.i.d. Cohort
Dose-escalation 900mg b.i.d. Cohort
Cohort-expansion

Trial Design

1Treatment groups
Experimental Treatment
Group I: BVD-523Experimental Treatment1 Intervention
BVD-523 is administered at the RP2D of 600mgs taken twice daily orally for 28 consecutive days (1 cycle). Planned does may modified based on toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BVD-523
2013
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

BioMed Valley Discoveries, IncIndustry Sponsor
16 Previous Clinical Trials
725 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,859 Total Patients Enrolled
Elizabeth Buchbinder, MDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

BVD-523 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03417739 — Phase 2
Uveal Melanoma Research Study Groups: BVD-523
Uveal Melanoma Clinical Trial 2023: BVD-523 Highlights & Side Effects. Trial Name: NCT03417739 — Phase 2
BVD-523 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03417739 — Phase 2

Frequently Asked Questions

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

Are any new participants being admitted to this trial?

"This research trial is no longer searching for participants, as it was first posted on March 26th 2018 and last updated November 22nd 2022. If you are looking to explore other trials, there are currently 756 studies actively recruiting patients with melanoma and 7 clinical trials specifically seeking out BVD-523 candidates."

Answered by AI

How many participants are involved in this investigation?

"This trial has finished the recruitment process. That being said, it was posted on March 26th 2018 and last updated November 22nd 2022. As far as other studies go, there are 756 clinical trials presently accepting patients with melanoma and a further seven trials for BVD-523 that still need participants."

Answered by AI

Has there been prior research exploring the effects of BVD-523?

"Presently, 7 clinical trials are being carried out to assess the effects of BVD-523. Of those, none have reached Phase 3 as yet. Most studies for this medication occur in Salt Lake City but it is available at 1765 sites around the world."

Answered by AI

Has the medication BVD-523 been sanctioned by the FDA?

"BVD-523 has been deemed a 2 on our safety scale due to the existance of Phase 2 data that shows some evidence for its security but not yet its effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase II Study of BVD-523 in Metastatic Uveal Melanoma
Elizabeth Buchbinder, MD 2018. "A Phase II Study of BVD-523 in Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03417739.
~2 spots leftby Apr 2025
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