Using Biomarkers to Guide Safe Stopping of Immunotherapy in Patients with Advanced Melanoma: The PET-Stop Trial

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04462406

Provider View

This study is exploring whether using specific markers from PET/CT scans can help safely shorten the duration of immunotherapy in patients with advanced melanoma that cannot be surgically removed.

Patient Parameters

Program Overview

This phase II trial is investigating if biomarkers seen on PET/CT scans can help doctors decide when to safely stop anti-PD-1 therapy in patients with advanced melanoma that cannot be removed by surgery. Anti-PD-1 therapy is a common treatment for these patients, and the study aims to see if using these biomarkers can allow for an earlier discontinuation of the therapy without compromising patient safety.

Description

The main goal of this study is to see if patients with advanced melanoma can safely stop anti-PD-1 therapy after 12 months if their PET/CT scans and biopsies show no signs of active cancer. The study will also look at how many patients show a response in their tumor biopsies after 12 months of therapy and track overall survival rates.

Patients will continue their standard anti-PD-1 therapy and be divided into two groups based on their PET/CT scan and biopsy results:

  • Group A: Patients with no signs of active cancer on their scans or biopsies will stop the therapy and be closely monitored.
  • Group B: Patients with signs of active cancer will continue their therapy for another 12 months unless their disease progresses or they experience severe side effects.

The study will follow patients for up to five years to monitor their health and any potential side effects from the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have advanced melanoma that cannot be surgically removed (stage IIIB-IV).
  • Melanoma must originate from skin, mucosal, or acral-lentiginous sites, not from the eye.
  • Must have measurable disease before starting anti-PD-1 therapy.
  • Currently receiving standard anti-PD-1 therapy for 52 weeks and able to continue without severe side effects.
  • Must have a performance status score of 0-2, indicating good overall health.
  • HIV-positive patients must have an undetectable viral load on treatment.
  • Hepatitis B and C patients must have controlled or cured infections.
  • Must have stable heart function if there is a history of heart disease.
  • Must have a complete or partial response or stable disease on scans at 52 weeks.
  • Must have completed a PET/CT scan at 52 weeks.
  • Must have adequate blood counts and organ function.
  • Women of childbearing potential must use effective contraception during and after the study.

Exclusion Criteria

  • Cannot be receiving other anti-tumor therapies besides standard anti-PD-1 regimens.
  • Cannot have brain metastases.
  • Women cannot be pregnant or breastfeeding.
  • Women of childbearing potential and sexually active men must use effective contraception during and after the study.

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