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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.

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

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment and procedure

Nivolumab, Surgery, Radiotherapy

The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.

View registry record

Treatment and procedure

Nivolumab, Surgery, Chemoradiotherapy

The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.

View registry record

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 Site

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (2)

Nivolumab, Surgery, Radiotherapy

Nivolumab, Surgery, Chemoradiotherapy

Interventions

Registry intervention entries

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (2)

Nivolumab, Surgery, Radiotherapy

Nivolumab, Surgery, Chemoradiotherapy

Interventions

Registry intervention entries

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations