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New pill plus immunotherapy takes on tough melanoma

NCT ID NCT06624644

Disease control Sponsor: Linnaeus Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, LNS8801, taken as a daily pill, either alone or with the immunotherapy pembrolizumab, in people with advanced melanoma that has not responded to prior treatments. About 135 participants will be randomly assigned to one of three groups: LNS8801 alone, LNS8801 plus pembrolizumab, or standard treatments chosen by their doctor. The main goal is to see how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LNS8801 (a tablet that targets a protein called GPER) and pembrolizumab (an immunotherapy drug)
What this could lead to
If it works, this could offer a new treatment option for people with advanced melanoma that has stopped responding to standard therapies.
What could go wrong
This is an early-to-mid stage trial with only 135 participants, so results may not apply to everyone. The drug may not improve outcomes or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous melanoma Melanoma (skin cancer) Melanoma stage IIIB-IV Unresectable melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dana Farber

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 87535, United States

  • Stanford

    RECRUITING

    Stanford, California, 94305, United States

  • UCSF

    RECRUITING

    San Francisco, California, 94143, United States

  • UPenn

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • USC Newport Beach

    RECRUITING

    Newport Beach, California, 92663, United States

  • University of Colorado

    RECRUITING

    Denver, Colorado, 80204, United States

    Contact Email: •••••@•••••

  • University of Colorado Anschutz

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

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