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

Using biomarkers to guide safe stopping of immunotherapy in advanced melanoma.

Recruiting
18 years and older
All
Phase 2

Study Overview: This study looks at stopping immunotherapy early for people with advanced melanoma, a type of skin cancer that can't be removed by surgery. They use special tests called PET/CT scans and tumor biopsies to help decide if it's safe to stop the treatment. The treatment involves drugs called anti-PD-1 therapies, which help the immune system fight cancer.

  • Study Length: The study lasts up to 5 years with follow-ups every 3 months.
  • Eligibility: You must have advanced melanoma and be receiving anti-PD-1 therapy.
  • Risks: Possible side effects from stopping or continuing therapy; requires regular scans and biopsies.

Key Details: Patients will either stop or continue their treatment based on the scan and biopsy results. If the scan shows no active cancer, they may stop the treatment and be watched carefully. If the scan or biopsy shows active cancer, they continue the treatment. Regular follow-ups ensure they are monitored closely.

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

13 December 2024

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