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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07773987
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Head and Neck Cancer Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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).

Key Dates

First listed
Aug 19, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: INITIUM regimen using ENI
    The INITIUM regimen includes two cycles of induction therapy with pembrolizumab, followed by pre-operative hypofractionated radiation (7 Gy × 5 fractions) and two additional cycles of pembrolizumab. Patients will receive ENI to non-clinically and radiographically involved draining nodal basins.
  • Experimental: INITIUM regimen without ENI
    The INITIUM regimen includes two cycles of induction therapy with pembrolizumab, followed by pre-operative hypofractionated radiation (7 Gy × 5 fractions) and two additional cycles of pembrolizumab. Patients will NOT receive ENI to non-clinically and radiographically involved draining nodal basins.

Primary Outcome Measure

Pathologic complete response (pCR) rate to INITIUM-HN with and without ENI. [ Time Frame: Up to 10 weeks post-radiation therapy ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Musaddiq Awan, MD
414-805-4400

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