NCT03843515 (NeoNivo) is a Phase 1 clinical trial of Nivolumab in Oral Cavity Squamous Cell Carcinoma, sponsored by Amsterdam UMC, location VUmc.

Who is sponsoring NCT03843515?

NCT03843515 is sponsored by Amsterdam UMC, location VUmc.

What drugs are being tested in NCT03843515?

Interventions in NCT03843515: Nivolumab.

What condition does NCT03843515 study?

NCT03843515 studies Oral Cavity Squamous Cell Carcinoma.

Is NCT03843515 still recruiting?

NCT03843515 is currently status unknown. Last updated 8 October 2021.

Last reviewed 2021-10-08 · How we verify

NCT03843515: NeoNivo

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

Neoadjuvant Nivolumab for Oral Cancer Combined With FDG and Anti-PD-L1 PET/CT Imaging for Response Prediction

Status unknown Phase 1 Last updated 8 October 2021

What this trial tests

Phase 1 trial testing Nivolumab in Oral Cavity Squamous Cell Carcinoma in 17 participants. Status unknown.

Timeline

11 April 2019

Primary endpoint
30 November 2021

31 August 2022

Quick facts

Lead sponsor	Amsterdam UMC, location VUmc
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	11 April 2019
Primary completion	30 November 2021
Estimated completion	31 August 2022
Sites	1 location across Netherlands

Drugs / interventions tested

Nivolumab (nivolumab) — full drug profile →

Conditions studied

Oral Cavity Squamous Cell Carcinoma — all drugs for Oral Cavity Squamous Cell Carcinoma →

Sponsor

Amsterdam UMC, location VUmc — full company profile →

Who can join

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

Sponsor's own description

Safety and tolerability of neoadjuvant nivolumab for locally advanced resectable oral cancer, combined with \[18F\]BMS-986192 / \[18F\]-FDG PET imaging and immunomonitoring for response prediction

Publications & conference data

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

Cancer-Derived Extracellular Vesicle-Associated MicroRNAs in Intercellular Communication: One Cell's Trash Is Another Cell's Treasure.
Mills J, Capece M, Cocucci E, Tessari A, et al · · 2019 · cited 51× · PMID 31817101 · DOI 10.3390/ijms20246109
PET/CT imaging for tumour response assessment to immunotherapy: current status and future directions.
Unterrainer M, Ruzicka M, Fabritius MP, Mittlmeier LM, et al · · 2020 · cited 40× · PMID 33200246 · DOI 10.1186/s41747-020-00190-1
Protein scaffolds: antibody alternatives for cancer diagnosis and therapy.
Luo R, Liu H, Cheng Z. · · 2022 · cited 37× · PMID 35866165 · DOI 10.1039/d2cb00094f
The neoadjuvant paradigm reinvigorated: a review of pre-surgical immunotherapy in HNSCC.
Stafford M, Kaczmar J. · · 2020 · cited 33× · PMID 32195008 · DOI 10.1186/s41199-020-00052-8
Promising Biomarkers in Head and Neck Cancer: The Most Clinically Important miRNAs.
Thomaidou AC, Batsaki P, Adamaki M, Goulielmaki M, et al · · 2022 · cited 27× · PMID 35897831 · DOI 10.3390/ijms23158257
MicroRNAs in head and neck squamous cell carcinoma: a possible challenge as biomarkers, determinants for the choice of therapy and targets for personalized molecular therapies.
Vahabi M, Blandino G, Di Agostino S. · · 2021 · cited 27× · PMID 35116619 · DOI 10.21037/tcr-20-2530
Noninvasive Imaging of Cancer Immunotherapy.
Abousaway O, Rakhshandehroo T, Van den Abbeele AD, Kircher MF, et al · · 2021 · cited 27× · PMID 33391977 · DOI 10.7150/ntno.50860
Harnessing imaging tools to guide immunotherapy trials: summary from the National Cancer Institute Cancer Imaging Steering Committee workshop.
Shankar LK, Schöder H, Sharon E, Wolchok J, et al · · 2023 · cited 21× · PMID 36858729 · DOI 10.1016/s1470-2045(22)00742-2

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 Oral Cavity 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
NCT07121595 — Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cel · Phase 2 · recruiting
NCT06947668 — Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel · recruiting
NCT06662058 — Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radi · NA · recruiting
NCT06532279 — Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patient · Phase 2 · recruiting

Other Amsterdam UMC, location VUmc trials

Trials by the same sponsor.

NCT07470697 — Deep Relaxation Using Virtual Reality Intervention Before Surgery for Healthcare Professionals Working in the Operating · NA · not yet recruiting
NCT07278206 — Brain Stimulation in Long COVID · NA · recruiting
NCT07155681 — Evaluating Healthcare Professionals' Satisfaction and Stress Mitigation Using Virtual Reality Intervention in Surgical W · NA · not yet recruiting
NCT06416345 — Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care · NA · recruiting
NCT06658522 — Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effec · Phase 4 · 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 NCT03843515 (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 Amsterdam UMC, location VUmc
Last refreshed: 8 October 2021

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/NCT03843515.

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