Clinical Trial 23474

• Overview

  Study Title:

  A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma

  Summary:

  The goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma. The primary question to be answered is what is the average length of time during which melanoma does not grow or spread after starting treatment with LNS8801? Researchers will compare LNS8801 taken alone or LNS8801 taken together with another drug called pembrolizumab to other therapies as decided by the treating doctor.

  Objective:

  Primary Objective * The primary objective of this 3-arm clinical trial is to compare progression-free survival (PFS) in the LNS8801 + pembrolizumab arm vs the Physicians Choice (PC) arm using RECIST 1.1. Secondary Objectives * Compare overall survival (OS) of LNS8801 + pembrolizumab vs PC treatment * Compare PFS of LNS8801 monotherapy vs physician s choice using RECIST 1.1. * Compare OS of LNS8801 vs PC treatment * Compare PFS of LNS8801 monotherapy vs LNS8801 + pembrolizumab using RECIST 1.1 * Compare OS of LNS8801 monotherapy vs LNS8801 + pembrolizumab * Compare the safety and tolerability between treatment arms and therapeutic interventions.

• Treatments

  Therapies:

  Chemotherapy (NOS); GPER agonist; Immunotherapy

  Medications:

  BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); DTIC (Dacarbazine); Dacarbazine (); Ipilimumab (); LNS8801 (); Nivolumab (Opdivo); Pembrolizumab (Keytruda); Relatlimab (); Temodal (Temozolomide); Temozolomide (); Yervoy (Ipilimumab)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Confirmed unresectable and/or metastatic cutaneous melanoma.
  • 2 copies of the fully functional form of GPER protein-coding sequence.
  • Eligible for and willing to receive 1 or more of the physician's choice (PC) therapies.
  • Able to swallow tablets.
  • Progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies.
  • Received an anti-CTLA-4 and/or BRAF containing regimen or is not eligible for or has declined anti-CTLA-4 and/or BRAF therapy prior to and for this study.
  • Measurable disease.
  • Eastern Cooperative Oncology Group Performance Status of 0 to 1.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Blue nevus subtype, mucosal, acral lentiginous, or uveal/ocular/choroidal Melanoma.
  • Previous anti-cancer or investigational drug/device treatment within 4 weeks of the first dose of study drug.
  • Radiotherapy within 2 weeks of starting study drug.
  • Allogeneic tissue/solid organ transplant.
  • Unstable autoimmune or immunodeficiency disease.
  • Other concurrent health issues that would make participation or completion of the study difficult.
  • Prior reaction to anti PD-1 therapy that would make treatment with pembrolizumab unadvisable.
  • Other protocol-defined inclusion/exclusion criteria may apply.

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