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NCT03161431 · ClinicalTrials.gov registry record · Phase 1
SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab
A Phase 1 study of Melanoma Stage IV and Melanoma Stage III, sponsored by Syntrix Biosystems.
- Active
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 6
- Study locations
NCT03161431: Active Phase 1 study of Melanoma Stage IV and Melanoma Stage III, sponsored by Syntrix Biosystems.
NCT03161431 is a Phase 1 study of Melanoma Stage IV and Melanoma Stage III that is active but no longer recruiting, run by Syntrix Biosystems. The registered enrollment target is 77 participants, below the 98-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (21% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03161431, a Phase 1 study of Melanoma Stage IV and Melanoma Stage III, is active but no longer recruiting, sponsored by Syntrix Biosystems.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
During the Monotherapy Stage participant cohorts will be enrolled at increasing doses of SX-682. The highest SX-682 dose tested at which no more than 1 of 6 cohort participants experiences a DLT will define the SX-682 monotherapy MTD.
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 |
What the registry record for NCT03161431 still lists
NCT03161431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 98-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (21% lower).
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.
NCT03161431 lists 6 locations in 5 states (Massachusetts, Florida, Minnesota).
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.
What interventions are being tested in trial NCT03161431?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), SX-682 (DRUG).
Who is sponsoring clinical trial NCT03161431?
This trial is sponsored by Syntrix Biosystems, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03161431's enrollment target sits among peer trials
77 9th of 17 higher than 9 of 17 other Melanoma Stage IV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma Stage IV 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.
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