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NCT02521870 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Dynavax Technologies Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 241
- Enrollment target
NCT02521870: Clinical Trial Phase 1 study, sponsored by Dynavax Technologies Corporation.
NCT02521870 is a Phase 1 study that was terminated before completion, run by Dynavax Technologies Corporation. The registered enrollment target is 241 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (302% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02521870, a Phase 1 study, was terminated before completion, sponsored by Dynavax Technologies Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 241 participants
- Enrollment target
Study 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).
Primary Outcome
Dose-limiting toxicities (DLTs) are defined per protocol as specific AEs occurring from the time of the first injection (Day 1) through Day 29.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG SD-101(1)
- DRUG SD-101(2)
- BIOLOGICAL SD-101(3)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2015-09 |
| Est. Completion | 2020-04 |
| Phase | Phase 1 |
Why NCT02521870 stopped before completion
NCT02521870 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (302% higher).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT02521870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02521870 about?
NCT02521870 is a clinical study titled "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". 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...
What is the current status of trial NCT02521870?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 241 participants. The study started on 2015-09. Estimated completion is 2020-04.
What interventions are being tested in trial NCT02521870?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), SD-101(1) (DRUG), SD-101(2) (DRUG), SD-101(3) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02521870?
This trial is sponsored by Dynavax Technologies Corporation, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02521870's enrollment target sits among peer trials
241 196th of 2000 higher than 1,804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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