Last updated on March 2019

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma


Brief description of study

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy nave and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Detailed Study Description

This study will be conducted in two parts.

Phase 1b is dose escalation in which patients are tested with SD-101 at various doses in combination with 200 mg pembrolizumab in patients with metastatic melanoma.

Phase 2 will consist of 7 expansion cohorts to evaluate the efficacy and safety of SD-101 given in combination with 200 mg pembrolizumab in specific melanoma populations and recurrent or metastatic HNSCC.

Clinical Study Identifier: NCT02521870

Contact Investigators or Research Sites near you

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Stanford Hospitals and Clinics

Palo Alto, CA United States
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University of Colorado

Aurora, CO United States
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Levine Cancer Institute

Charlotte, NC United States
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Huntsman Cancer institute

Salt Lake City, UT United States
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University of Alabama

Birmingham, AL United States
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UCSF

San Francisco, CA United States
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Georgia Cancer Specialists

Decatur, GA United States
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Northwestern University

Chicago, IL United States
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University of Iowa Healthcare

Iowa City, IA United States
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University of Michigan

Ann Arbor, MI United States
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Atlantic Health

Morristown, NJ United States
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The Christ Hospital

Cincinnati, OH United States
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West Virginia University

Morgantown, WV United States
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The Tweed Hospital

Tweed Heads, Australia
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Christchurch Hospital

Christchurch, New Zealand
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Waikato Hospital

Hamilton, New Zealand
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Liverpool Hospital

Westmead, Australia
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Melanoma Institute

Wollstonecraft, Australia
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Adelaide Cancer Centre

Kurralta Park, Australia
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Recruitment Status: Open


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