LNS8801 alone or with pembrolizumab for people whose melanoma has stopped responding.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized 1:1:1 multicenter trial enrolling about 135 patients who pass a prescreen blood test for the GPER C/C genotype. Eligible patients with unresectable or metastatic cutaneous melanoma who progressed on prior anti‑PD‑1 therapy will be assigned to LNS8801 alone, LNS8801 plus pembrolizumab, or a physician's choice arm that may include chemotherapy or other immunotherapies. LNS8801 is given orally daily; pembrolizumab is given IV every 3 weeks (with an option to switch to 400 mg every 6 weeks after 6 months), and treatment may continue for up to about 2 years. The trial’s primary focus is on safety, tolerability, and the length of time cancer does not grow (progression‑free survival) comparing the experimental arms to physician's choice.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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.

Where it's running

• USC Newport Beach
  Newport Beach, California, United States Recruiting
• UCSF
  San Francisco, California, United States Recruiting
• Stanford
  Stanford, California, United States Recruiting
• University of Colorado Anschutz
  Aurora, Colorado, United States Recruiting
• University of Colorado
  Denver, Colorado, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Sudha Velayutham
• Email: svelayutham@lumabridge.com
• Phone: 210-563-8441

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.