NCT03721757

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

5.8 years

First QC Date

July 23, 2018

Last Update Submit

February 24, 2025

Conditions

Squamous Cell Carcinoma of the Oral Cavity

Keywords

Head and Neck cancerSquamous cell carcinoma

Outcome Measures

Primary Outcomes (2)

  • Disease free survival

    1 year disease free survival defined as disease recurrence or death at 12 months from surgery

    Patients will be followed up for 12 months following surgery

  • Recruitment Rate

    Measured as the number of patients/site/month

    Period of recruitment

Secondary Outcomes (8)

  • Overall survival

    Patients will be followed up for 12 months following surgery

  • Surgical complications - Infection rate

    up to 8 weeks post date of surgery

  • Surgical complications - length of hospital admission

    up to 8 weeks post date of surgery

  • Surgical complications - free flap failure

    up to 8 weeks post date of surgery

  • Surgical complications - perioperative (30-day mortality)

    up to 30 days post date of surgery

  • +3 more secondary outcomes

Study Arms (2)

Nivolumab, Surgery, Radiotherapy

OTHER

Patients will be treated with a single dose of nivolumab (240mg flat dose), followed by surgery to remove their tumour within 1-2 weeks. Based on pathological risk factors determined following surgery, patients will be assigned to undergo adjuvant radiotherapy or chemoradiotherapy. Patients with low risk criteria following surgery will be assigned to radiotherapy. A single dose of nivolumab (240mg flat dose) will be given between surgery and commencement of radiotherapy (1-2 weeks prior). Radiotherapy will be administered over 30 fractions i.e. over 30 days (Monday to Friday for 6 consecutive weeks). Following completion of radiation (within 1-2 weeks), patients will commence adjuvant nivolumab, with a total of 6 doses (480mg flat dose) given at 4 weekly intervals

Biological: Nivolumab, Surgery, Radiotherapy

Nivolumab, Surgery, Chemoradiotherapy

OTHER

Patients will be treated with a single dose of nivolumab (240mg flat dose), followed by surgery to remove their tumour within 1-2 weeks. Based on pathological risk factors determined following surgery, patients will be assigned to undergo adjuvant radiotherapy or chemoradiotherapy. Patients with high risk criteria following surgery will be assigned to chemoradiotherapy. A single dose of nivolumab (240mg flat dose) will be given between surgery and chemoradiotherapy (1-2 weeks prior). Chemoradiotherapy will be administered over 30 fractions i.e. over 30 days with concomitant Cisplatin (100mg/m2) on day 1 and 21. Following completion of radiation (within 1-2 weeks), patients will commence adjuvant nivolumab, with a total of 6 doses (480mg flat dose) given at 4 weekly intervals.

Biological: Nivolumab, Surgery, Chemoradiotherapy

Interventions

Nivolumab, Surgery, RadiotherapyBIOLOGICAL

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

Also known as: Curative Surgery, Adjuvant Radiotherapy
Nivolumab, Surgery, Radiotherapy
Nivolumab, Surgery, ChemoradiotherapyBIOLOGICAL

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

Also known as: Curative surgery, Adjuvant chemoradiotherapy
Nivolumab, Surgery, Chemoradiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Tumours staged as T4 on the basis of bone invasion only and in the absence of nodal metastases.
  • Distant metastases detected, or suspected on imaging
  • Unfit for chemoradiotherapy, due to comorbidity.
  • Previous malignancy requiring treatment within the last 3 years (with the exception of non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, oesophageal endometrial, cervical/dysplasia, melanoma, or breast). Prior head and neck cancer within the last three years is allowed if the tumour was treated with surgery only, and did not require radiotherapy.
  • Prior head and neck radiotherapy
  • On immunosuppressive medication (including steroids at dose equivalent to prednisolone \>10mg/day unless used as replacement therapy).
  • Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, lichen planus or other conditions not expected to recur in the absence of an external trigger are permitted to enrol.
  • Known human immunodeficiency virus (HIV) or viral hepatitis infection.
  • Women who are pregnant or breastfeeding
  • Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, CH634JY, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

NivolumabSurgical Procedures, OperativeRadiotherapyRadiotherapy, AdjuvantChemoradiotherapyChemoradiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTherapeuticsCombined Modality TherapyDrug Therapy

Study Officials

  • Joseph Sacco, MBChB

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

October 26, 2018

Study Start

May 10, 2019

Primary Completion

February 24, 2025

Study Completion

February 24, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)