An Early Phase 1 interventional study of Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] in Head and Neck Neoplasms, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Henry Ford Health System · Early Phase 1, Interventional, and Treatment
The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.
Approximately 30-40% of patients treated with a curative intent for locally advanced squamous cell carcinoma of the head and neck cancer will experience an isolated loco-regional recurrence or a second primary tumor in the previously radiated tissues1-5. Patients with recurrent head and neck cancer frequently recur locally and are still amenable for curative interventions. The current recommendations for treatment of these recurrent and second primary tumors includes surgical resection whenever possible as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy.
Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. However, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of patients.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 10 is below the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 24 (65%) have results posted.
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Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
Drug page: Pembrolizumab
Patients will receive 17 cycles of pembrolizumab via IV infusion of 200 mg over a period of 30 minutes, every 3 weeks starting no later than 90 days from the date of salvage head and neck therapy.
Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).
Primary objective
Time frame: 1 year
Determine the feasibility of immunotherapy for head and neck cancer following salvage surgery to produce preliminary data for 15 patients regarding efficacy. All side effects and symptoms will be assessed by CTCAE v5.0.
Study endpoint
Time frame: 1 year
Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.
Study endpoint
Time frame: through study completion, an average of 1 year
Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.
Study endpoint
Time frame: through study completion, an average of 1 year
Plan to share: Yes — This study is to obtain pilot data. The data may be shared with other researchers. Participants will sign a research HIPAA authorization to release their data. All participants will be assigned a study specific ID number.
Supporting information: Study protocol, Informed consent form
Time frame: Data will become available after the study has completed enrollment and patient treatment. The data will be available indefinitely unless specified.
Access criteria: Access will be limited to collaborators within and beyond Henry Ford Health System.
No publications or documents are linked to this record.
Ran from Oct 2019 to primary completion in Jun 2023, 44 months.
Of 83 non-industry phase 1 interventional studies under Head and Neck Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 63. This study's 44 months is close to that.
Counting every sponsor, half of 135 studies reached it within 43 months; a quarter within 32 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab