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X4P-001 and Pembrolizumab in Patients With Advanced Melanoma

NCT02823405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-07-07

No results posted yet for this study

Summary

The goals of this protocol are 1) to investigate the safety and tolerability of X4P-001 in combination with Keytruda® (pembrolizumab) in patients with advanced melanoma, and 2) to assess serial biopsies of melanoma tumor lesions obtained throughout the study for inflammatory and tumor cell infiltrates. After completion of study treatment, participants with resectable disease will undergo surgery, unresectable participants may continue on pembrolizumab as standard of care.

Conditions

Interventions

DRUG

X4P-001

X4P-001 100 mg capsules, administered orally, continuous daily dosing

DRUG

Pembrolizumab

Pembrolizumab 2 mg/kg, administered by IV infusion every 3 weeks

Sponsors & Collaborators

  • X4 Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lu Gan, MD, PhD · X4 Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-15
Primary Completion
2018-03-15
Completion
2018-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02823405 on ClinicalTrials.gov