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NCT03690986
VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer
Phase 1 trial testing VX15/2503 in Squamous Cell Carcinoma of the Head and Neck in 50 participants. Currently enrolling.
4 June 2026
Quick facts
| Lead sponsor | Emory University |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 November 2018 |
| Primary completion | 4 June 2026 |
| Estimated completion | 30 November 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- VX15/2503 — full drug profile →
- Ipilimumab — full drug profile →
- Nivolumab (nivolumab) — full drug profile →
Conditions studied
- Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →
Sponsor
Emory University
Who can join
18 and older, any sex, with Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Combination of Ipilimumab and Nivolumab in Cancers: From Clinical Practice to Ongoing Clinical Trials.
Kooshkaki O, Derakhshani A, Hosseinkhani N, Torabi M, et al · · 2020 · cited 95× · PMID 32580338 · DOI 10.3390/ijms21124427 -
Immune Evasion by Head and Neck Cancer: Foundations for Combination Therapy.
Horton JD, Knochelmann HM, Day TA, Paulos CM, et al · · 2019 · cited 65× · PMID 30961829 · DOI 10.1016/j.trecan.2019.02.007 -
Myeloid Cells as Clinical Biomarkers for Immune Checkpoint Blockade.
Peranzoni E, Ingangi V, Masetto E, Pinton L, et al · · 2020 · cited 60× · PMID 32793228 · DOI 10.3389/fimmu.2020.01590 -
Tumor microenvironment and immune-related therapies of head and neck squamous cell carcinoma.
Qin Y, Zheng X, Gao W, Wang B, et al · · 2021 · cited 55× · PMID 33614915 · DOI 10.1016/j.omto.2021.01.011 -
Functionalized Nanoparticles Targeting Tumor-Associated Macrophages as Cancer Therapy.
He Y, de Araújo Júnior RF, Cruz LJ, Eich C. · · 2021 · cited 48× · PMID 34683963 · DOI 10.3390/pharmaceutics13101670 -
Semaphorins as emerging clinical biomarkers and therapeutic targets in cancer.
Mastrantonio R, You H, Tamagnone L. · · 2021 · cited 48× · PMID 33537086 · DOI 10.7150/thno.54023 -
Granulocytic Myeloid-Derived Suppressor Cells as Negative Regulators of Anticancer Immunity.
Kramer ED, Abrams SI. · · 2020 · cited 42× · PMID 32983128 · DOI 10.3389/fimmu.2020.01963 -
Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
Verify or expand the search:
- PubMed search for NCT03690986
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of VX15/2503
Trials testing the same drug.
- NCT03769155 — VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Melanoma · Phase 1 · active not recruiting
Other recruiting trials for Squamous Cell Carcinoma of the Head and Neck
Currently open trials in the same condition.
- NCT07465276 — Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC · Phase 2 · recruiting
- NCT06736379 — Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer · Phase 1 · recruiting
- NCT06223568 — Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subject · Phase 2 · recruiting
- NCT05983133 — A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors · Phase 1 · active not recruiting
- NCT05208762 — A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors · Phase 1 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03690986 (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 Emory University
- Last refreshed: 23 July 2025
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/NCT03690986.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing