BVD-523 for Uveal Melanoma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: CYP inhibitors, CYP inducers

Disqualifiers: Pregnancy, Uncontrolled illness, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: up to 52 weeks

13 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are taking strong inhibitors or inducers of certain liver enzymes (CYP1A2, CYP2D6, and CYP3A4). It's important to discuss your current medications with the study team to ensure there are no interactions.

How does the drug BVD-523 differ from other treatments for uveal melanoma?

BVD-523 is a targeted therapy that may interfere with specific pathways critical in tumor development or progression, which is a novel approach compared to traditional treatments for uveal melanoma that have not been effective in preventing or treating metastases. ^{1 2 3 4 5}

What is the purpose of this trial?

This research study is studying a targeted therapy called BVD-523 as a possible treatment for advanced uveal melanoma.

Research Team

Elizabeth Buchbinder, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

I have at least one tumor that can be measured.

My cancer has spread and can be biopsied.

I agree to use birth control during the study.

Exclusion Criteria

Participants who are receiving any other investigational agents

I haven't had chemotherapy or radiotherapy in the last 4 weeks.

I have not had major surgery within the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BVD-523 at the RP2D of 600mgs taken twice daily orally for 28 consecutive days per cycle

up to 52 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 52 weeks

Follow-up visits every 4 weeks

Treatment Details

Interventions

• BVD-523

Trial Overview 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.

Participant Groups

Group I: BVD-523 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

BioMed Valley Discoveries, Inc

Industry Sponsor

Trials

19

Recruited

650+

Findings from Research

Current adjuvant therapies for uveal melanoma have not been effective in preventing metastasis, highlighting the need for new treatment strategies.

New approaches are focusing on using genetic criteria to tailor immunotherapy and targeted treatments for patients at risk, with ongoing clinical trials exploring these innovative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant Therapy of Uveal Melanoma: Current Status. Triozzi, PL., Singh, AD.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Adjuvant Therapy of Uveal Melanoma: Current Status. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Role of immune checkpoint inhibitors in metastatic uveal melanoma: a single-center retrospective cohort study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effect of oncolytic ECHO-7 virus strain Rigvir on uveal melanoma cell lines. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Targeted therapy for uveal melanoma. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Biology of advanced uveal melanoma and next steps for clinical therapeutics. [2021]