Related Experiment Video

Updated: Feb 6, 2026

Minimally Invasive Isolated Limb Perfusion (MI-ILP) for Locally Advanced Melanomas and Sarcomas of the Extremity
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Minimally Invasive Isolated Limb Perfusion (MI-ILP) for Locally Advanced Melanomas and Sarcomas of the Extremity

Published on: January 31, 2025

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SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase Ib, Multicenter Study

Antoni Ribas1, Theresa Medina2, Shivaani Kummar3

  • 1Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California. aribas@mednet.ucla.edu.

Cancer Discovery
|August 30, 2018
PubMed

Insights

Combining intratumoral SD-101, an immune stimulant, with pembrolizumab showed promising results for advanced melanoma patients. This approach activated the immune system and led to durable tumor responses with manageable side effects.

Area of Science:

  • Immunology
  • Oncology
  • Pharmacology

Background:

  • Advanced melanoma is often treated with PD-1 inhibitors, but resistance can occur.
  • Intratumoral SD-101 is a synthetic CpG oligonucleotide that stimulates Toll-like receptor 9 (TLR9).

Purpose of the Study:

  • To evaluate the safety and efficacy of intratumoral SD-101 in combination with pembrolizumab for unresectable or metastatic malignant melanoma.
  • To assess the immune activation within the tumor microenvironment.

Main Methods:

  • Phase Ib clinical trial.
  • Combination therapy with intratumoral SD-101 and pembrolizumab.
  • RNA profiling of tumor biopsies.

Main Results:

  • In PD-1 naïve patients (n=9), the overall response rate (ORR) was 78%, with 12-month progression-free survival of 88% and overall survival of 89%.
  • In patients with prior anti-PD-1 therapy (n=13), the ORR was 15%.
  • Tumor biopsies showed increased CD8+ T cells, NK cells, cytotoxic cells, dendritic cells, and B cells.

Conclusions:

  • The combination of SD-101 and pembrolizumab is well tolerated and induces broad immune activation.
  • This combination therapy demonstrates potential for increased clinical efficacy in melanoma treatment with minimal additional toxicity.

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