Phase 3 Melanoma Trial, Recruiting NCT06624644 Sponsor: Linnaeus Therapeutics, Inc. Condition: Melanoma
Back to Melanoma

Phase 3 Melanoma Trial, Recruiting

NCT06624644
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with skin melanoma (a type of skin cancer) that cannot be removed by surgery and/or has spread to other parts of the body.
  • Your body has two copies of a normally working version of a specific gene related to a protein called GPER (confirm with trial site).
  • Your doctor has identified one or more treatment options they would recommend for you, and you are willing to receive them.
  • You are able to swallow tablets.
  • Your melanoma got worse while you were receiving a specific type of immunotherapy drug (called an anti-PD-1 treatment), whether given alone or with other treatments.
  • You have previously received, are not eligible for, or have chosen not to receive certain other treatments for melanoma (called anti-CTLA-4 and/or BRAF-targeted therapies).
  • Your cancer can be measured on scans or tests.
  • You are generally able to carry out daily activities, with little to no limitations from your illness (confirm with trial site).

Who may not be able to join:

  • Your melanoma is a specific less common type, including blue nevus, mucosal, acral lentiginous, or eye-related (uveal/ocular/choroidal) melanoma.
  • You have received any cancer treatment or experimental treatment within 4 weeks before starting the study drug.
  • You have had radiation therapy within 2 weeks before starting the study drug.
  • You have previously received an organ or tissue transplant from another person.
  • You have an unstable autoimmune condition or a disease that weakens your immune system.
  • You have other ongoing health conditions that could make it hard to safely participate in or complete the study.
  • You previously had a serious reaction to anti-PD-1 therapy that would make it unsafe to use a related drug called pembrolizumab.
  • There may be additional criteria not listed here that could affect eligibility (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 210-563-8441

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Linnaeus Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
6 August 2025
Est. completion
1 February 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Compare progression-free survival (PFS) of LNS8801 + pembrolizumab vs PC arms as assessed by RECIST v1.1.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov