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
Public ClinicalTrials.gov record NCT02521870. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02521870
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 241 participants
Conditions and interventions
Conditions
Interventions
- SD-101(1) Drug
- Pembrolizumab Biological
- SD-101(2) Drug
- SD-101(3) Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2015 (Type not available)
- Primary completion
- Apr 2020 (Actual)
- Completion
- Apr 2020 (Actual)
- Last update posted
- Aug 3, 2021
2015 – 2020
United States locations
- U.S. sites
- 30
- U.S. states
- 23
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama School of Medicine | Birmingham | Alabama | 35294 | — |
| University of Alabama | Birmingham | Alabama | 35294 | — |
| University of Arizona Cancer Center | Tucson | Arizona | 85721 | — |
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| Stanford Hospitals and Clinics | Palo Alto | California | 94305 | — |
| University of California, San Diego | San Diego | California | 92093 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| Georgia Cancer Center - Northside Hospital Central Research Department | Atlanta | Georgia | 30341 | — |
| Northwestern University | Chicago | Illinois | 60208 | — |
| University of Iowa Healthcare | Iowa City | Iowa | 52242 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68130 | — |
| Atlantic Health | Morristown | New Jersey | 07962 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| University Hospitals Cleveland Medical Center - Seidman Cancer center | Cleveland | Ohio | 44106 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Mary Crowley Cancer Research Center | Dallas | Texas | 75230 | — |
| University of Utah Health Care - Huntsman Cancer institute | Salt Lake City | Utah | 84112 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02521870, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02521870 live on ClinicalTrials.gov.