Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SYNERGY-001)
Study ID: NCT02521870
Study Description
Brief Summary: 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). This study will be conducted in 2 phases. Phase 1 evaluates SD-101 given in combination with pembrolizumab in melanoma populations (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease) in up to 4 Dose Escalation cohorts to identify a recommended Phase 2 dose (RP2D) to be evaluated in up to 4 Dose Expansion cohorts in Phase 2. Phase 2 also includes up to 4 Dose Expansion cohorts of patients with HNSCC (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama School of Medicine, Birmingham, Alabama, United States
University of Alabama, Birmingham, Alabama, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
University of California, Los Angeles, Los Angeles, California, United States
Stanford Hospitals and Clinics, Palo Alto, California, United States
University of California, San Diego, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
University of Colorado, Aurora, Colorado, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Georgia Cancer Center - Northside Hospital Central Research Department, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Iowa Healthcare, Iowa City, Iowa, United States
University of Michigan, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Atlantic Health, Morristown, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
The Christ Hospital, Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center - Seidman Cancer center, Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Providence Portland Medical Center, Portland, Oregon, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
University of Utah Health Care - Huntsman Cancer institute, Salt Lake City, Utah, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
West Virginia University, Morgantown, West Virginia, United States
The Tweed Hospital, Tweed Heads, New South Wales, Australia
Liverpool Hospital, Westmead, New South Wales, Australia
Melanoma Institute, Wollstonecraft, New South Wales, Australia
Adelaide Cancer Centre - Ashford Cancer Centre, Kurralta Park, South Australia, Australia
Hollywood Private Hospital / Affinity Research, Nedlands, Western Australia, Australia
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Klinikum BuxtehudeDermato-Onkologie Studienzentrale, Buxtehude, , Germany
Uniklinikum Dresden Klinik und Poliklinik für Dermatologie, Dresden, , Germany
Universitätshautklinik Frankfurt, Frankfurt, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
HNO-Universitätsklinik Jena, Jena, , Germany
Universitätshautklinik Magdeburg, Magdeburg, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Universitätsklinikum Tübingen, Tubingen, , Germany
Auckland City Hospital, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Contact Details
Name: Antoni Ribas, MD
Affiliation: UCLA School of Medicine (Melanoma)
Role: PRINCIPAL_INVESTIGATOR
Name: Ezra Cohen, MD
Affiliation: UCSD Moores Cancer Center (HNSCC)
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas Tüting, MD
Affiliation: University Hospital Magdeburg
Role: PRINCIPAL_INVESTIGATOR
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