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Active, not recruiting Phase 1 Interventional

SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab

ClinicalTrials.gov ID: NCT03161431

Public ClinicalTrials.gov record NCT03161431. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 4:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Open-Label, Dose-Escalation With Expansion Study of SX-682 in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03161431
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Syntrix Biosystems, Inc.
Industry
Enrollment
77 participants

Conditions and interventions

Interventions

Drug · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 11, 2019
Primary completion
Jul 31, 2026
Completion
May 31, 2027
Last update posted
Dec 22, 2025

2019 – 2027

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
University of Miami Miami Florida 33136
Massachusetts General Hospital Cancer Center Boston Massachusetts 02114
Dana-Farber Cancer Institute Boston Massachusetts 02215
Mayo Clinic Rochester Minnesota 55905
Wilmot Cancer Institute - University of Rochester Rochester New York 14642
MD Anderson Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03161431, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 22, 2025 · Synced Sep 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03161431 live on ClinicalTrials.gov.

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