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SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab
NCT03161431 · View on ClinicalTrials.gov ↗
Study Summary
Cancers attract myeloid-derived suppressor cells (MDSCs) that prevent our own immune responses from destroying the cancer. This study will be the first study to begin to determine if the newly discovered drug SX-682 can block cancers from attracting MDSCs. This first study will enroll participants with melanoma, as melanoma cancer has been shown to be able to attract MDSCs. The study will begin to determine if SX-682 is a safe and effective treatment of melanoma. It is thought that SX-682 will block MDSCs from going to the cancer, and thus will allow a patient's own immune system to attack the cancer. The first participants enrolled in the study will receive for 21 days SX-682 as monotherapy. After 21 days participants will receive pembrolizumab therapy (an approved immunotherapy for melanoma) in combination with SX-682 for up to approximately 2 years. Once the safe dose level of SX-682 in combination with pembrolizumab is determined, the remaining participants will be enrolled at the highest safe dose level of SX-682, in combination with pembrolizumab. These participants will receive the combination therapy and be evaluated in the study for approximately 2 years.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG SX-682
Study Locations (6)
Massachusetts
- Massachusetts General Hospital Cancer Center — Boston
- Dana-Farber Cancer Institute — Boston
Florida
- University of Miami — Miami
Minnesota
- Mayo Clinic — Rochester
New York
- Wilmot Cancer Institute - University of Rochester — Rochester
Texas
- MD Anderson — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03161431
The ClinicalTrials.gov registry entry for NCT03161431 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syntrix Biosystems, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Melanoma Stage IV appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03161431 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Massachusetts, Florida, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03161431 about?
NCT03161431 is a clinical study titled "SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab". Cancers attract myeloid-derived suppressor cells (MDSCs) that prevent our own immune responses from destroying the cancer. This study will be the first study to begin to determine if the newly discovered drug SX-682 can block cancers from attracting MDSCs. This first study will enroll participants w...
What is the current status of trial NCT03161431?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2019-06-12. Estimated completion is 2027-06.
What conditions does trial NCT03161431 study?
This clinical trial studies the following conditions: Melanoma Stage IV, Melanoma Stage III. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03161431?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), SX-682 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03161431?
This trial is sponsored by Syntrix Biosystems, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03161431 being conducted?
This trial has 6 study locations across Florida, Massachusetts, Minnesota, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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