NCT04848116 (Spark2) is a Phase 2 clinical trial of Nivolumab in Head and Neck Squamous Cell Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Who is sponsoring NCT04848116?

NCT04848116 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

What drugs are being tested in NCT04848116?

Interventions in NCT04848116: Nivolumab, HuMax-IL8.

What condition does NCT04848116 study?

NCT04848116 studies Head and Neck Squamous Cell Carcinoma.

Is NCT04848116 still recruiting?

NCT04848116 is currently active, enrolled. Last updated 13 May 2026.

Last reviewed 2026-05-13 · How we verify

NCT04848116: Spark2

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

Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Cancer Patients Undergoing Surgery

Active, enrolled Phase 2 Last updated 13 May 2026

What this trial tests

Phase 2 trial testing Nivolumab in Head and Neck Squamous Cell Carcinoma in 24 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 April 2021

Primary endpoint
1 April 2027

1 November 2030

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	24 April 2021
Primary completion	1 April 2027
Estimated completion	1 November 2030
Sites	1 location across United States

Drugs / interventions tested

Nivolumab (nivolumab) — full drug profile →
HuMax-IL8 — full drug profile →

Conditions studied

Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety of neoadjuvant Nivolumab in combination with HuMax
Time frame: Up to 100 days after the last dose of study drug
Adverse events will be reviewed to determine the safety of the combination of investigational products in the neoadjuvant setting. AEs and other toxicities will be graded using NCI Common Terminology Criteria for Adverse Events 5.0 (CTCAE).
Feasibility of neoadjuvant Nivolumab in combination with HuMax
Time frame: Up to 100 days after the last dose of study drug
Adverse events will be reviewed to determine the feasibility of the combination of investigational products in the neoadjuvant setting. AEs and other toxicities will be graded using NCI Common Terminology Criteria for Adverse Events 5.0 (CTCAE).

Sponsor's own description

The primary objective of this study is to assess safety and feasibility of pre-operative nivolumab in combination with BMS-986253 (anti-interleukin-8) in patients with squamous cell carcinoma of head and neck (SCCHN) who will undergo surgery.

Publications & conference data

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

The chemokines CXCL8 and CXCL12: molecular and functional properties, role in disease and efforts towards pharmacological intervention.
Cambier S, Gouwy M, Proost P. · · 2023 · cited 387× · PMID 36725964 · DOI 10.1038/s41423-023-00974-6
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
Tumor cell plasticity in targeted therapy-induced resistance: mechanisms and new strategies.
Shi ZD, Pang K, Wu ZX, Dong Y, et al · · 2023 · cited 168× · PMID 36906600 · DOI 10.1038/s41392-023-01383-x
Emerging strategies in targeting tumor-resident myeloid cells for cancer immunotherapy.
Wang Y, Johnson KCC, Gatti-Mays ME, Li Z. · · 2022 · cited 103× · PMID 36031601 · DOI 10.1186/s13045-022-01335-y
Roles of the CXCL8-CXCR1/2 Axis in the Tumor Microenvironment and Immunotherapy.
Han ZJ, Li YB, Yang LX, Cheng HJ, et al · · 2021 · cited 88× · PMID 35011369 · DOI 10.3390/molecules27010137
Tumor-associated macrophages remodel the suppressive tumor immune microenvironment and targeted therapy for immunotherapy.
Yang Y, Li S, To KKW, Zhu S, et al · · 2025 · cited 77× · PMID 40380196 · DOI 10.1186/s13046-025-03377-9
Cancer Resistance to Immunotherapy: Comprehensive Insights with Future Perspectives.
Said SS, Ibrahim WN. · · 2023 · cited 75× · PMID 37111629 · DOI 10.3390/pharmaceutics15041143
CXCR2 chemokine receptor - a master regulator in cancer and physiology.
Lazennec G, Rajarathnam K, Richmond A. · · 2024 · cited 53× · PMID 37872025 · DOI 10.1016/j.molmed.2023.09.003

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma · Phase 2 · not yet recruiting

Other recruiting trials for Head and Neck Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT06980038 — Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone i · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT06995508 — Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial · Phase 2 · recruiting
NCT07254585 — SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma · Phase 2 · recruiting
NCT07514754 — Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients · NA · recruiting

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting
NCT06210854 — Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ · Phase 2 · not yet recruiting
NCT07360119 — Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors · NA · not yet recruiting
NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting

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 NCT04848116 (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 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 13 May 2026

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/NCT04848116.

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