Clinical trial

A Single Arm Phase 2 Study of Adjuvant Nivolumab After Salvage Resection in Head and Neck Squamous Cell Carcinoma Patients Previously Treated With Definitive Therapy

Name

UCCI-HN-17-01

Description

The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.

Trial arms

Trial start

2017-12-06

Estimated PCD

2024-01-01

Trial end

2024-07-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Nivolumab

Nivolumab 480 mg IV infusion

Arms:

Nivolumab

Other names:

Opdivo

Size

Primary endpoint

Percentage of patients with Grade 3 and 4 adverse events of nivolumab

28 weeks

Eligibility criteria

Inclusion Criteria: * Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options * Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated. * Able to provide archived biopsy or resected tissue. * Adequate performance status and labs. Exclusion Criteria: * Patients who did not receive at least radiotherapy as prior definitive treatment. * Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control. * Has nasopharyngeal or sinonasal carcinoma. * Has confirmed metastatic disease.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 39, 'type': 'ESTIMATED'}}

Updated at

2024-02-28

1 organization

1 drug

1 indication

Organization

Trisha Wise-Draper

Drug

T-VEC

Indication

Head and Neck Cancer