A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma

Conditions

• Cutaneous Melanoma
• Melanoma (Skin Cancer)
• Melanoma Stage IIIB-IV
• Unresectable Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LNS8801 — BIOLOGICAL
  G protein-coupled estrogen receptor (GPER) agonist
• Pembrolizumab — BIOLOGICAL
  Recombinant monoclonal antibody (anti-PD1)
• Chemotherapy (dacarbazine or temozolomide) — DRUG
  chemotherapy (dacarbazine, temozolomide)
• Immunotherapy (Pembrolizumab) — BIOLOGICAL
  pembrolizumab
• Immunotherapy (nivolumab and relatlimab) — BIOLOGICAL
  nivolumab and relatlimab
• Immunotherapy (ipilimumab and nivolumab) — BIOLOGICAL
  ipilimumab and nivolumab

Study Details

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? Researchers will compare LNS8801 taken alone or LNS8801 taken together with another drug called pembrolizumab to other therapies as decided by the treating doctor. 135 patients will be randomly (like flipping a coin) placed in 3 treatment groups. In the first group (LNS8801 only) - Patients will take 125mg tablet of LNS8801 by mouth once per day every day for up to 2 years. In the second group (LNS8801 + pembrolizumab) - Patients will take 125mg tablet of LNS8801 by mouth once per day plus 200 mg of pembrolizumab by IV infusion once every 3 weeks for up to 2 years. In the third group, called Physician's Choice (PC), patients will receive chemotherapy (dacarbazine or temozolomide) or immunotherapy (pembrolizumab, nivolumab/relatlimab or nivolumab/ipilimumab) as determined by their treating physician. How often the patient visits the clinic visits will depend on the treatment group. Besides returning to the clinic for treatment, the patient will undergo periodic safety assessments and other required study procedures such as imaging assessments.

Key Dates

Start date

Aug 6, 2025

Status verified

Sep 2025

Primary completion

Feb 28, 2029

Completion

Feb 28, 2031

Study Design

Enrollment

135 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LNS8801 Monotherapy
  125 mg LNS8801 by mouth every day
• Experimental: LNS8801 + Pembrolizumab
  125 mg LNS8801 by mouth every day plus 200 mg Pembrolizumab by IV infusion once every 3 weeks.
• Active Comparator: Physician's Choice
  patients may receive chemotherapy or immunotherapy as determined by physician.

Primary Outcome Measure

Compare progression-free survival (PFS) of LNS8801 + pembrolizumab vs PC arms as assessed by RECIST v1.1. [ Time Frame: up to 2 years. ]

Central Contacts

• Sudha Velayutham
  210-563-8441
  [email protected]

Locations (9)

Find similar trials in Newport Beach, CA

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