MC# 15-31 - A Phase Ib/II, Open-label, Multicenter, Dose-escalation and expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma

  • Agent(s): SD-101, Pembrolizumab
  • Disease Type(s): Head and Neck, Melanoma
  • Phase(s): I, II
  • Drug Classification(s): Targeted Therapy, Immunotherapy
  • Molecular Target(s): PD-1

Mechanism of Action

The SD-101 drug substance is a 30-mer phosphorothioate (PS) oligodeoxynucleotide (ODN) containing juxtaposed cytidine-phospho-guanosine (CpG) motifs with flanking regions, in a self-complimentary palindromic sequence that is designated as a Class C-type sequence (CpG-C).  The CpG-C type sequences are an agonist for Toll-like receptor 9 (TLR9) and potent inducers of interferon alpha (IFN-α) production from plasmacytoid dendritic cells (pDCs), as well as pDC maturation and B cell proliferation.  Potential mechanisms by which TLR9 stimulation by CpG-ODNs may have a significant antitumor effect include enhancement of innate and T-cell immunity, stimulation of cytokines with direct or indirect antitumor activities (including IFN-α), and production of cytotoxic antibodies.


The purpose of this study is to assess the safety and tolerability of escalating doses of SD-101 in combination with pembrolizumab in patients with metastatic melanoma.

Inclusion Criteria
  • Histologically or cytologically confirmed unresectable in-transit (stage IIIc) or metastatic (stage IV) melanoma.
  • At least 1 site of disease which must be palpable and easily accessible for intratumoral injection. A second site of disease that can be assessed is desirable. Patients must have measurable disease as defined per immune related response criteria.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • Adequate organ function.
Exclusion Criteria
  • Active autoimmune disease or immunosuppressive disease.
  • Active Central Nervous System (CNS) metastatic disease.
  • Prior therapy with an investigational antibody targeting immunoregulatory receptors or mechanisms (with exception of ipilimumab, anti- PD-1 antibody, or anti-PD-L1 antibody).


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
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