A Phase 2 Open-label Multicenter Cohort Study of ALKS 4230 Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]1 Therapy - ARTISTRY-6

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 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) The patient must have one of the following tumor types: Cohort 1 (advanced cutaneous melanoma cohort): Patient has unresectable and/or metastatic cutaneous melanoma. No more than 5 patients with acral melanoma may enroll in this cohort. ? Cohort 2 (advanced mucosal melanoma cohort): Patient has unresectable and/or metastatic mucosal melanoma. 2) The patient must have received previous treatment as follows: a. Patient has received anti-PD-[L]1 therapy with or without anti-CTLA-4 therapy, and no more than one other prior regimen of systemic anti-neoplastic therapy (eg, targeted therapy, chemotherapy). Previous adjuvant and/or neoadjuvant therapy counts as one prior line. b. Patients should have experienced objective response (partial response [PR] or CR; by RECIST 1.1 or iRECIST) or stable disease (SD; by RECIST 1.1 or iRECIST) as best overall response (BOR) to anti-PD-[L]1 therapy. Patients with confirmed progressive disease (by RECIST 1.1 or iRECIST) as best response may be included, if they received anti-PD-[L]1 therapy for a minimum of 12 weeks (eg, 4 doses of pembrolizumab every 3 weeks). c. Patients with BRAF mutations may or may not have received prior targeted therapy. 3) Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue.

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

  • 1) Patient has uveal melanoma. 2) Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof. 3) Patient has received radiotherapy within the last 4 weeks before start of study treatment, with the exception of limited field palliative radiotherapy to an area not inclusive of or adjacent to the target lesion(s), that has been completed at least 2 weeks before starting study treatment with no ongoing acute sequelae (eg, radiation burns).

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