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New treatment option for Squamous Cell Carcinoma
Official title Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
ClinicalTrials.gov ID: NCT06731933
What this study is testing
What is BVEC?
BVEC is an investigational medicine, being studied as a potential treatment for squamous cell carcinoma.
Also referred to as Beremagene Geperpavec.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence. Prevention of SCC's in the RDEB subjects will increase their life span.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
- Presence of biopsy proven squamous cell carcinoma (SCC)
- Ability to understand and the willingness to provide written informed consent.
- US based participants are willing to use beremagene geperpavec (BVEC)
- Subject is 18 years or older
You likely can't join if
- Inability to travel to site for study visit
- Subject is pregnant
- Subject has Metastatic SCC's or is on any current systemic treatment for SCC.
See the full eligibility criteria
- Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
- Presence of biopsy proven squamous cell carcinoma (SCC)
- Ability to understand and the willingness to provide written informed consent.
- US based participants are willing to use beremagene geperpavec (BVEC)
- Subject is 18 years or older
- participant willingness to use an effective method of contraception
- Inability to travel to site for study visit
- Subject is pregnant
- Subject has Metastatic SCC's or is on any current systemic treatment for SCC.
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
- Bari, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States; Bari, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.