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CA209-891: Neoadjuvant and Adjuvant Nivolumab as Immune Checkpoint Inhibition in Oral Cavity Cancer

NCT03721757 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-02-25

No results posted yet for this study

Summary

This trial is to investigate the use of nivolumab in sequence with standard of care surgery and radiation/chemoradiation in locally advanced oral cavity Squamous cell carcinoma of the oral cavity.

Conditions

  • Squamous Cell Carcinoma of the Oral Cavity

Interventions

BIOLOGICAL

Nivolumab, Surgery, Radiotherapy

A single dose of nivolumab 7-14 days before curative surgery. A further single dose will be administered following surgery and prior to radiotherapy commencing. Six further doses of nivolumab will be received post radiotherapy

BIOLOGICAL

Nivolumab, Surgery, Chemoradiotherapy

A single dose of nivolumab 7-14 days before curative surgery. A further single dose will be administered following surgery and prior to Chemoradiotherapy (cisplatin) commencing. Six further doses of nivolumab will be received post radiotherapy

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Joseph Sacco, MBChB · University of Liverpool

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2025-02-24
Completion
2025-02-24

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03721757 on ClinicalTrials.gov