A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop) [EA6192]

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition. 2) Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. 3) Patients with melanoma of unknown primary site are eligible. 4) Patients must not have melanoma from an ocular primary site and have had measurable disease by immune related Response Evaluation Criteria in Solid Tumors (imRECIST) prior to start of initial anti-PD-1 therapy.

You may not be eligible for this study if the following are true:

  • 1) Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. 2) Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases are eligible. 3) Patient must not have brain metastases. 4) Women must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the anti-PD-1 regimens being used.

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