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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 is a Phase 1 study that was terminated before completion, run by Dynavax Technologies Corporation. The registered enrollment target is 241 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02521870
The ClinicalTrials.gov registry entry for NCT02521870 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dynavax Technologies Corporation, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT02521870 reports 0 study locations.
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.
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