Immunotherapy + Radiotherapy for Head and Neck Cancer
(INITIUM Trial)
What You Need to Know Before You Apply
What is the purpose of 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).
Who Is on the Research Team?
Musaddiq Awan, MD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
This trial is for adults with head and neck squamous cell carcinoma that can be removed by surgery. Participants should be healthy enough for treatment and surgery, but specific inclusion or exclusion details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Participants receive two cycles of pembrolizumab as induction therapy
Radiation Therapy
Participants undergo pre-operative hypofractionated radiation with or without ENI
Post-Radiation Therapy
Participants receive two additional cycles of pembrolizumab
Surgery
Response-directed surgery approximately eight weeks after completion of radiation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elective Nodal Irradiation (ENI)
- Pembrolizumab
- Radiotherapy
- Surgery
Trial Overview
The study tests pembrolizumab (an immunotherapy drug) combined with radiotherapy, either with or without elective nodal irradiation (ENI), before surgery in people with resectable head and neck cancer. Patients are randomly assigned to one of the two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
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