Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (21% lower). The listed sponsor is Syntrix Biosystems, which has 9 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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
Similar trials for Melanoma Stage IV
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.
-
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
RECRUITING · Phase 1
-
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
RECRUITING · Phase 1
-
A Study of VET3-TGI in Patients With Solid Tumors
RECRUITING · Phase 1
-
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
ACTIVE NOT RECRUITING · Phase 1
-
IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
RECRUITING · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.