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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

241

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

April 30, 2020

Study Completion Date

April 30, 2020

Conditions
Metastatic MelanomaHead Neck Cancer
Interventions
DRUG

SD-101(1)

SD-101 administered intratumorally at escalating doses (up to 11 doses).

BIOLOGICAL

Pembrolizumab

Pembrolizumab administered intravenously, 200 mg Q3W for two years (up to 35 doses).

DRUG

SD-101(2)

Dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses).

BIOLOGICAL

Pembrolizumab

Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).

BIOLOGICAL

SD-101(3)

Dose Q1W for 4 weeks followed by dose Q3W for 16 additional weeks (up to 20 total doses).

BIOLOGICAL

Pembrolizumab

Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).

Trial Locations (47)

1023

Auckland City Hospital, Auckland

2065

Melanoma Institute, Wollstonecraft

2170

Liverpool Hospital, Westmead

2485

The Tweed Hospital, Tweed Heads

3204

Waikato Hospital, Hamilton

4710

Christchurch Hospital, Christchurch

5037

Adelaide Cancer Centre - Ashford Cancer Centre, Kurralta Park

14263

Roswell Park Cancer Institute, Buffalo

17033

Penn State Hershey Medical Center, Hershey

22031

Inova Schar Cancer Institute, Fairfax

26506

West Virginia University, Morgantown

27710

Duke University Medical Center, Durham

28204

Levine Cancer Institute, Charlotte

29425

Medical University of South Carolina, Charleston

30341

Georgia Cancer Center - Northside Hospital Central Research Department, Atlanta

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

35294

University of Alabama School of Medicine, Birmingham

University of Alabama, Birmingham

44106

University Hospitals Cleveland Medical Center - Seidman Cancer center, Cleveland

45219

The Christ Hospital, Cincinnati

48109

University of Michigan, Ann Arbor

48201

Barbara Ann Karmanos Cancer Institute, Detroit

52242

University of Iowa Healthcare, Iowa City

55455

University of Minnesota Masonic Cancer Center, Minneapolis

60208

Northwestern University, Chicago

68130

Nebraska Methodist Hospital, Omaha

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75230

Mary Crowley Cancer Research Center, Dallas

80045

University of Colorado, Aurora

84112

University of Utah Health Care - Huntsman Cancer institute, Salt Lake City

85721

University of Arizona Cancer Center, Tucson

90095

University of California, Los Angeles, Los Angeles

92093

University of California, San Diego, San Diego

94158

University of California San Francisco, San Francisco

94305

Stanford Hospitals and Clinics, Palo Alto

97213

Providence Portland Medical Center, Portland

07962

Atlantic Health, Morristown

Unknown

Hollywood Private Hospital / Affinity Research, Nedlands

Charité - Universitätsmedizin Berlin, Berlin

Klinikum BuxtehudeDermato-Onkologie Studienzentrale, Buxtehude

Uniklinikum Dresden Klinik und Poliklinik für Dermatologie, Dresden

Universitätshautklinik Frankfurt, Frankfurt

Medizinische Hochschule Hannover, Hanover

HNO-Universitätsklinik Jena, Jena

Universitätshautklinik Magdeburg, Magdeburg

Universitätsklinikum Regensburg, Regensburg

Universitätsklinikum Tübingen, Tübingen

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Dynavax Technologies Corporation

INDUSTRY