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Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial

The PET-Stop Trial: Biomarkers and immunotherapy for advanced melanoma guidance.

Recruiting
18 years and older
All
Phase 2

This study is checking how safe it is to stop a treatment called **anti-PD-1 therapy** early for people with advanced **melanoma**, a type of skin cancer that can't be removed by surgery. Anti-PD-1 therapy is a common treatment for this kind of melanoma. This trial uses special tests called **PET/CT scans** and **biopsies** to look for signs of cancer and decide if the treatment can be stopped early without harming the patient.

Key Points to Consider:

  • The trial lasts up to 5 years, with regular check-ins even after treatment ends.
  • Participants continue their usual treatment and may stop based on test results.
  • Risks include potential side effects from stopping the treatment early.

Participants must have a type of melanoma that cannot be surgically removed and should be in good health otherwise. They will need to have regular PET/CT scans and possibly biopsies. The goal is to see if patients can safely stop therapy early, which might lessen side effects and treatment costs. Check eligibility and discuss any concerns with your doctor before joining.

Study details
    Advanced Melanoma
    Clinical Stage III Cutaneous Melanoma AJCC v8
    Clinical Stage IV Cutaneous Melanoma AJCC v8
    Melanoma of Unknown Primary
    Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
    Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
    Pathologic Stage IIID Cutaneous Melanoma AJCC v8
    Pathologic Stage IV Cutaneous Melanoma AJCC v8
    Unresectable Acral Lentiginous Melanoma
    Unresectable Melanoma
    Unresectable Mucosal Melanoma

NCT04462406

ECOG-ACRIN Cancer Research Group

23 August 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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