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New Pill-and-Immunotherapy combo aims to shrink melanoma before surgery

NCT ID NCT07565285

Disease control Sponsor: Primmune 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 6 times

Summary

This phase 2 trial tests whether adding an experimental immune-boosting pill (PRTX007) to standard immunotherapy (pembrolizumab) before surgery can improve outcomes for people with stage III melanoma. About 48 adults with resectable melanoma will take the combination for 9 weeks before surgery. The main goal is to see how many patients have a major reduction in tumor cells after treatment.

What this could mean

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

Active substance
PRTX007 (an immune-boosting pill) combined with pembrolizumab (an immunotherapy drug)
What this could lead to
If successful, this combination could improve the chance of eliminating or shrinking melanoma tumors before surgery, potentially leading to better long-term outcomes.
What could go wrong
This is an early phase 2 study with only 48 participants, so results may not apply to everyone. The combination may cause significant immune-related side effects, and it is not yet known if it works better than standard treatment.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

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

Started

Jul 2026

Expected to finish

Jun 2029

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: * Adults aged 18 years or older * Histologically confirmed, resectable Stage III cutaneous melanoma. * Candidate for curative-intent surgical resection * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Adequate organ function * Able to provide written informed consent Exclusion Criteria: * Prior systemic therapy for melanoma, including immunotherapy * Uveal melanoma or mucosal melanoma. * Active autoimmune disease requiring systemic treatment * Primary immunodeficiency or use of systemic immunosuppressive therapy * Women who are pregnant or breastfeeding * Recent treatment with another investigational therapy * Any condition that, in the opinion of the investigator, would interfere with study participation or safety

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma

As listed by the trial registrant

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

Melanoma stage III

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Cairns And Hinterland Hospital And Health Service

    NOT_YET_RECRUITING

    Cairns, Queensland, 4870, Australia

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Gallipoli Medical Research

    NOT_YET_RECRUITING

    Greenslopes, Queensland, 4120, Australia

  • One Clinical Research Pty Ltd

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Peter MacCallum Cancer Centre

    NOT_YET_RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    NOT_YET_RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Sir Charles Gairdner Hospital

    NOT_YET_RECRUITING

    Nedlands, Western Australia, 6009, Australia

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