Adjuvant Therapy

A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients with a High Risk of Recurrence.

Key Eligibility Criteria:

  • Histologically confirmed AJCC Stage IIB, IIC or III melanoma, surgically excised, with no evidence of residual disease
  • Last definitive surgical resection of all clinically evident disease within 90 days of first POL-103A or placebo dosing. 

Patients whose melanomas are deeply invasive or who have had lymph node metastasis of their melanoma are at high risk for recurrence and/or spread of their melanoma to other parts of their body.  This study involves use of a vaccine aimed at boosting the patient’s immune responses to their tumor with the hope that this immune response will eliminate any melanoma cells that might have escaped before surgery and improve the chance for survival.  The therapies currently approved by the FDA for use in this setting are poorly effective and highly toxic (Intron A, Sylatron) or carry the risk of death (Yervoy).  More effective and less toxic treatments are needed for these patients.  This vaccine has not been associated with serious toxicity and may offer improved efficacy.

 

Patients with unresectable Stage IIIB to IVM1c Melanoma

Randomized Trial of Pembrolizumab with T-VEC or Placebo for Treatment of Unresected Stage IIIB to IV M1c Melanoma

Key Eligibility Criteria: 

  • Unresected, Stage IIIB to IVM1c Melanoma
  • No prior chemotherapy
  • Measurable disease with injectable lesions present

Pembrolizumab is an anti-PD1 monoclonal antibody that has shown promising efficacy in the treatment of metastatic melanoma, is approved for that purpose, and is being widely used in melanoma immunotherapy.  T-VEC is injected into patient’s melanoma tumors and enhances the patient’s immune response to his/her own tumor.  This study is designed to determine whether this combination will produce better therapeutic results than results obtained with pembrolizumab alone. 

 

Patients Whose Melanoma Has Progressed Despite the Best Currently Available Treatments

A Study of Glembatumumab Vedotin as Monotherapy or in Combination with Varlilumab in Patients with Advanced Melanoma

Key Eligibility Criteria: 

  • Patients with unresectable melanoma who have had disease progression through of after standard therapies
  • Prior treatments received must include at least one check-point inhibitor (e.g., Anti-CTLA4, PD-1, PD-L1-targeted immunotherapy) and for patients with a BRAF mutation at least one BRAF- or MEK-targeted therapy, unless patients are not candidates for, or refused, these therapies

Glembatumumab vedotin (Glemba) is a monoclonal antibody that is conjugated to a potent small molecule anti-cancer agent.  Glemba targets the melanoma tumors and carries to anti-cancer agent to them, with the goal of killing the melanoma cells.  A clinical trial of Glemba gave encouraging results that it does provide clinical benefit to patients with melanoma who have had disease progression despite the best currently available treatments.  Varlilumab is an immunotherapy consisting of a monoclonal antibody that enhances the immune responses.  The purpose of this study is to determine clinical efficacy of this combination.