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

Stopped early · Phase 1/Phase 2

Conditions studied: Metastatic Melanoma, Head Neck Cancer

In brief

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).

Key facts

Study ID

NCT02521870

Run by

Dynavax Technologies Corporation

People needed

241

Starts

2015-09-01

Expected to finish

2020-04-01

Last updated by the study team

2021-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.