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New treatment option for Melanoma (Skin Cancer)
Official title A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
ClinicalTrials.gov ID: NCT06624644
What this study is testing
What is LNS8801?
LNS8801 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma (skin cancer).
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 goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma. The primary question to be answered is what is the average length of time during which melanoma does not grow or spread after starting treatment with LNS8801?
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- Which group you join is decided by chance.
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
- Confirmed unresectable and/or metastatic cutaneous melanoma.
- 2 copies of the fully functional form of GPER protein-coding sequence.
- Eligible for and willing to receive 1 or more of the physician's choice (PC) therapies.
- Able to swallow tablets.
- Progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies.
You likely can't join if
- Blue nevus subtype, mucosal, acral lentiginous, or uveal/ocular/choroidal Melanoma.
- Previous anti-cancer or investigational drug/device treatment within 4 weeks of the first dose of study drug.
- Radiotherapy within 2 weeks of starting study drug.
- Allogeneic tissue/solid organ transplant.
- Unstable autoimmune or immunodeficiency disease.
- Other concurrent health issues that would make participation or completion of the study difficult.
See the full eligibility criteria
- Confirmed unresectable and/or metastatic cutaneous melanoma.
- 2 copies of the fully functional form of GPER protein-coding sequence.
- Eligible for and willing to receive 1 or more of the physician's choice (PC) therapies.
- Able to swallow tablets.
- Progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies.
- Received an anti-CTLA-4 and/or BRAF containing regimen or is not eligible for or has declined anti-CTLA-4 and/or BRAF therapy prior to and for this study.
- Measurable disease.
- Eastern Cooperative Oncology Group Performance Status of 0 to 1.
- Blue nevus subtype, mucosal, acral lentiginous, or uveal/ocular/choroidal Melanoma.
- Previous anti-cancer or investigational drug/device treatment within 4 weeks of the first dose of study drug.
- Radiotherapy within 2 weeks of starting study drug.
- Allogeneic tissue/solid organ transplant.
- Unstable autoimmune or immunodeficiency disease.
- Other concurrent health issues that would make participation or completion of the study difficult.
- Prior reaction to anti PD-1 therapy that would make treatment with pembrolizumab unadvisable.
- Other protocol-defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Albuquerque, New Mexico, United States
- Philadelphia, Pennsylvania, United States
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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Newport Beach, California, United States; San Francisco, California, United States; Stanford, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States; Tampa, Florida, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.