NCT02823405 (X4P-001-MELA) is a Phase 1 clinical trial of X4P-001 in Melanoma, sponsored by X4 Pharmaceuticals.

Who is sponsoring NCT02823405?

NCT02823405 is sponsored by X4 Pharmaceuticals.

What drugs are being tested in NCT02823405?

Interventions in NCT02823405: X4P-001, Pembrolizumab.

Is NCT02823405 still recruiting?

NCT02823405 is currently completed. Last updated 7 July 2020.

Last reviewed 2020-07-07 · How we verify

NCT02823405: X4P-001-MELA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

X4P-001 and Pembrolizumab in Patients With Advanced Melanoma

Completed Phase 1 Last updated 7 July 2020

What this trial tests

Phase 1 trial testing X4P-001 in Melanoma in 16 participants. Completed in 15 March 2018.

Timeline

15 September 2016

Primary endpoint
15 March 2018

15 March 2018

Quick facts

Lead sponsor	X4 Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	15 September 2016
Primary completion	15 March 2018
Estimated completion	15 March 2018
Sites	4 locations across United States

Drugs / interventions tested

X4P-001 — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →

Sponsor

X4 Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Macrophages as regulators of tumour immunity and immunotherapy.
DeNardo DG, Ruffell B. · · 2019 · cited 1903× · PMID 30718830 · DOI 10.1038/s41577-019-0127-6
A narrative review of tumor-associated macrophages in lung cancer: regulation of macrophage polarization and therapeutic implications.
Sedighzadeh SS, Khoshbin AP, Razi S, Keshavarz-Fathi M, et al · · 2021 · cited 160× · PMID 34012800 · DOI 10.21037/tlcr-20-1241
Neutrophils in the era of immune checkpoint blockade.
Faget J, Peters S, Quantin X, Meylan E, et al · · 2021 · cited 94× · PMID 34301813 · DOI 10.1136/jitc-2020-002242
CXCR4 and CXCR7 Signaling Pathways: A Focus on the Cross-Talk Between Cancer Cells and Tumor Microenvironment.
Santagata S, Ieranò C, Trotta AM, Capiluongo A, et al · · 2021 · cited 74× · PMID 33937018 · DOI 10.3389/fonc.2021.591386
Tenascin-C immobilizes infiltrating T lymphocytes through CXCL12 promoting breast cancer progression.
Murdamoothoo D, Sun Z, Yilmaz A, Riegel G, et al · · 2021 · cited 51× · PMID 33988305 · DOI 10.15252/emmm.202013270
Pathogenesis, diagnosis and therapeutic strategies in WHIM syndrome immunodeficiency.
Heusinkveld LE, Yim E, Yang A, Azani AB, et al · · 2017 · cited 40× · PMID 29057173 · DOI 10.1080/21678707.2017.1375403
Biased action of the CXCR4-targeting drug plerixafor is essential for its superior hematopoietic stem cell mobilization.
Jørgensen AS, Daugvilaite V, De Filippo K, Berg C, et al · · 2021 · cited 34× · PMID 33980979 · DOI 10.1038/s42003-021-02070-9
Determinants of resistance and response to melanoma therapy.
Robertson BM, Fane ME, Weeraratna AT, Rebecca VW. · · 2024 · cited 31× · PMID 39020103 · DOI 10.1038/s43018-024-00794-1

Verify or expand the search:

Other trials of X4P-001

Trials testing the same drug.

NCT05103917 — A Study to Assess the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination With TNBC · Phase 1, PHASE2 · unknown
NCT02923531 — Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma · Phase 1, PHASE2 · terminated
NCT02667886 — Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma · Phase 1, PHASE2 · completed
NCT02680782 — A Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers · Phase 1 · terminated

Other recruiting trials for Melanoma

Currently open trials in the same condition.

NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07379138 — Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improve · NA · recruiting

Other X4 Pharmaceuticals trials

Trials by the same sponsor.

NCT06914869 — Drug-Drug Interaction Potential of Mavorixafor · Phase 1 · completed
NCT04154488 — A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders · Phase 1, PHASE2 · completed
NCT04274738 — A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tum · Phase 1 · completed
NCT02923531 — Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma · Phase 1, PHASE2 · terminated
NCT02667886 — Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02823405 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by X4 Pharmaceuticals
Last refreshed: 7 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02823405.

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