A Phase Ib/II Study of IMCgp100 with Durvalumab and/or Tremelimumab in Cutaneous Melanoma

Full Title

A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination with Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients with Advanced Melanoma

Purpose

The purpose of this study is to evaluate IMCgp100 in combination with either durvalumab (MEDI4736, a PD-L1 inhibitor) alone, tremelimumab (a CLTA-4 inhibitor) alone, or the combination of durvalumab with tremelimumab compared to IMCgp100 alone in patients with metastatic melanoma that is refractory to treatment with an anti-PD-1 inhibitor, as well as in patients who have not yet had therapy for metastatic disease.

IMCgp100 may recruit "effector T cells" to a tumor and overcome the resistance a tumor has developed to immunotherapy with checkpoint blockade alone. The drugs in this study are given intravenously (by vein).

Eligibility

This study is for patients who:

  • Have advanced cutaneous melanoma (unresectable stage III or metastatic stage IV disease).
  • May or may not have received prior immunotherapy.
  • Are age 18 or older.

Patients with melanomas arising from acral or mucosal surfaces or the uveal tract (eye) are not eligible.

Patients must have HLA-A 02 allele or be willing to have a blood test for HLA-A typing.

For more information and to inquire about eligibility for this study, please contact Dr. Alexander Shoushtari at 646-888-4161.

Protocol

16-629

Phase

I/II

Co-Investigators

Diseases

Locations