SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab (NCT03161431)
A Phase 1, Open-Label, Dose-Escalation With Expansion Study of SX-682 in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Miami โ Miami, Florida
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (6 Sites)
- University of Miami โ Miami, Florida
- Massachusetts General Hospital Cancer Center โ Boston, Massachusetts
- Dana-Farber Cancer Institute โ Boston, Massachusetts
- Mayo Clinic โ Rochester, Minnesota
- Wilmot Cancer Institute - University of Rochester โ Rochester, New York
- MD Anderson โ Houston, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Melanoma Stage III
- Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab โ Durham, North Carolina
- Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis โ Boston, Massachusetts
- Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma โ Washington D.C., District of Columbia
- Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma โ La Jolla, California
- Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma โ Tampa, Florida
Explore by condition: All Melanoma Stage III clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.