Clinical trial 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 pill being studied as a potential treatment for melanoma. It is designed to activate a specific protein in the body called the G protein-coupled estrogen receptor (GPER).
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 wants to see how long melanoma stops growing after starting LNS8801, and whether adding pembrolizumab helps.
- Who it's for
- Adults with stage IIIB‑IV cutaneous melanoma that cannot be removed by surgery.
- What's involved
- Participants take a 125 mg LNS8801 pill daily for up to 2 years. Those in the combination arm also receive a 200 mg pembrolizumab infusion every 3 weeks. The third group gets standard chemotherapy or other immunotherapy chosen by their doctor. All groups have regular clinic visits for treatment and safety checks, including imaging tests.
- Time commitment
- The trial lasts up to 2 years, with clinic visits every 3 weeks for the pembrolizumab group and less frequent visits for the pill‑only group, plus routine safety and imaging assessments.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.