Immunotherapy and Nodal-Sparing Irradiation for T-Cell Induction and Unmasking of Tumor Antigenicity in the Microenvironment for Head and Neck Cancer

ConditionHead and Neck Cancer Squamous Cell Carcinoma

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedical College of Wisconsin

About this trial

This is a non-comparative randomized Phase 2 study using the INITIUM regimen with or without elective nodal irradiation (ENI) delivered before surgery for resectable head and neck squamous cell carcinoma (HNSCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years or older.

Patients with surgically resectable squamous cell carcinoma of the oral cavity or HPV-negative squamous cell carcinoma of the oropharynx. Resectability will be determined by the treating surgeon. Patients must have locoregionally advanced disease defined by clinical T3-4 staging and/or clinical node positive staging.

A CPS score of at least 1 on initial biopsy.

Zubrod, or Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Disqualifiers

HPV-positive squamous cell carcinoma of the oropharynx.

Tumor inaccessible for clinic-based biopsy as determined by the treating surgeon.

Solid organ transplant requiring chronic immunosuppression.

Autoimmune disease requiring use of steroids or chronic immunosuppression.

Trial design

Design model

Parallel

Treatments tested in this trial

Pembrolizumab
Drug
All patients will undergo induction with pembrolizumab (200 mg) given intravenously every three weeks for two cycles prior to radiation and two cycles after radiation.
Radiotherapy
Radiation
All patients will receive 7 Gy daily for 5 fractions to gross disease.
ENI
Radiation
Patients receiving ENI will be treated to 5.4 Gy daily to the elective nodal basins for 5 fractions concurrent with treatment to gross disease.
Surgery
Procedure/Surgery
Patients will be scheduled for surgery at ten weeks (-7 days) after radiation to allow for maximal tumor regression and healing of any radiation-related mucositis. Surgical resection will be tailored to the treatment response.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: INITIUM regimen using ENIExperimental treatment 4 interventions

Group B: INITIUM regimen without ENIExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Pathologic complete response (pCR) rate to INITIUM-HN with and without ENI.

pCR is defined as no viable tumor in primary tumor or lymph nodes on pathological examination.

Time frame

Up to 10 weeks post-radiation therapy

Sponsors and contacts

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Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: