NCT03784066 (DUTRELASCO) is a Phase 1, PHASE2 clinical trial of Durvalumab in Oral Cavity Squamous Cell Carcinoma, sponsored by Universitaire Ziekenhuizen KU Leuven.

Who is sponsoring NCT03784066?

NCT03784066 is sponsored by Universitaire Ziekenhuizen KU Leuven.

What drugs are being tested in NCT03784066?

Interventions in NCT03784066: Durvalumab, Durvalumab + Tremelimumab.

What condition does NCT03784066 study?

NCT03784066 studies Oral Cavity Squamous Cell Carcinoma.

Is NCT03784066 still recruiting?

NCT03784066 is currently active, enrolled. Last updated 3 July 2024.

Last reviewed 2024-07-03 · How we verify

NCT03784066: DUTRELASCO

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

Durvalumab With or Without Tremelimumab in Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity

Active, enrolled Phase 1, PHASE2 Last updated 3 July 2024

What this trial tests

Phase 1, PHASE2 trial testing Durvalumab in Oral Cavity Squamous Cell Carcinoma in 21 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 August 2018

Primary endpoint
24 March 2025

24 March 2026

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	27 August 2018
Primary completion	24 March 2025
Estimated completion	24 March 2026
Sites	1 location across Belgium

Drugs / interventions tested

Durvalumab — full drug profile →
Durvalumab + Tremelimumab

Conditions studied

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

Sponsor

Universitaire Ziekenhuizen KU Leuven — 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

This is a randomized, open-label, prospective, pilot phase I/II study with focus on translational research and on the evaluation of the biological changes that are observed in sequential tumor tissue acquisition in patients with newly diagnosed advanced (stage IV) oral cavity SCC. Patients are treated with Durvalumab (arm A) or Durvalumab + Tremelimumab (arm B) after biopsy-confirmed diagnosis of locally advanced resectable SCCHN of the oral cavity. After surgery, the standard of care treatment is radiotherapy, and, depending on risk assessment concurrent cisplatin. Patients will be treated with Durvalumab (arm A) or Durvalumab and Tremelimumab (arm B) during six additional cycles, starting from day one of the postoperative radiotherapy.

Publications & conference data

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

Trends in immunotherapy for oral squamous cell carcinoma.
Xue N, Wang Y, Wang Z, Zeng X, et al · · 2025 · cited 7× · PMID 40549116 · DOI 10.1007/s13402-025-01068-3
Prognostic and Predictive Biomarkers in Head and Neck Squamous Cell Carcinoma Treated with Radiotherapy-A Systematic Review.
Schanne DH, Koch A, Elicin O, Giger R, et al · · 2022 · cited 6× · PMID 36552043 · DOI 10.3390/biomedicines10123288
Protocol for whole-slide image analysis of human multiplexed tumor tissues using QuPath and R.
Franken A, Bila M, Lambrechts D. · · 2024 · cited 4× · PMID 39453815 · DOI 10.1016/j.xpro.2024.103270
Decoding tumor heterogeneity: A spatially informed pan-cancer analysis of the tumor microenvironment.
Lodi F, Vanmassenhove S, Chen D, Boeckx B, et al · · 2025 · cited 2× · PMID 41086810 · DOI 10.1016/j.xcrm.2025.102416
Single-cell omics in tumor lymph node metastasis: mechanisms and therapeutic implications.
Liu X, Meng X, Liu Z, Cao L, et al · · 2026 · PMID 41629958 · DOI 10.1186/s12943-026-02585-x
The emerging role of neoadjuvant immunotherapy in locally advanced oral squamous cell carcinoma: progress and challenges.
Zhao TC, Dai YB, Zhou ZH, Huang YY, et al · · 2026 · PMID 41532448 · DOI 10.1097/js9.0000000000004783

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

NCT07507968 — TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle · Phase 2 · not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce · Phase 2 · recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · 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 Universitaire Ziekenhuizen KU Leuven trials

Trials by the same sponsor.

NCT06831955 — LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer · Phase 2 · recruiting
NCT07356505 — Efficacy and Safety of Micra AV2 Transcatheter Pacing System · NA · recruiting
NCT07286968 — Gastro-Intestinal Digestion and Physiology After Bariatric Surgery · recruiting
NCT06962137 — Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer · Phase 2 · recruiting
NCT07270536 — Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection · NA · 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 NCT03784066 (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 Universitaire Ziekenhuizen KU Leuven
Last refreshed: 3 July 2024

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/NCT03784066.

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