Status:
RECRUITING
Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Head and Neck Carcinoma of Unknown Primary
Locally Recurrent Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains d...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the potential toxicity of immunotherapy and preoperative radiation combined with intra-operative radiation in patients with recurrent or persistent head and neck squ...
Eligibility Criteria
Inclusion
- Pathologically confirmed either persistent and/ or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck (H\&N) squamous cell carcinoma
- Resectable disease as determined by the surgeon and team
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) \< 2
- At least 18 years of age
- Adequate hematologic, renal, and hepatic function
- Must have at least 2 week washout period from prior therapy
- Willingness and ability to provide informed consent
- Negative pregnancy test for females of reproductive potential
- Patients who have undergone therapy for their cancer, such as surgery and/or chemotherapy and/or radiotherapy and recurred
- Disease measurable by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
- Prior definitive and palliative chemotherapy will be allowed
- Prior radiation therapy will be allowed
- Tumor tissue from resected site of disease must be provided for biomarker analyses, in addition to urine and blood sample as scheduled per protocol
- White blood cell (WBC) \>= 2000/uL (obtained within 14 days of randomization)
- Neutrophils \>= 1500/uL (obtained within 14 days of randomization)
- Platelets \>= 100 x10\^3/uL (obtained within 14 days of randomization)
- Hemoglobin \> 9.0 g/dL (obtained within 14 days of randomization)
- Serum creatinine =\< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) \>= 40 mL/min (Cockcroft and Gault or Wright formula may be used according to local practice) (obtained within 14 days of randomization)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional ULN
- Total Bilirubin =\< 1.5 x institutional ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
- Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for four months after the last dose of pembrolizumab.
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\])
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of four months after the last dose of investigational product
Exclusion
- Requirement of immunosuppressive therapy within 14 days of randomization
- Salivary gland carcinomas, lip carcinoma, adenocarcinoma of the skin
- Prior use of immune checkpoint blockade agent
- History of human immunodeficiency virus (HIV), hepatitis B, C: Participants who test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection, those who test positive for human immunodeficiency virus (HIV) or have known acquired immunodeficiency syndrome (AIDS)
- Unresectable disease, as determined by the surgeon and team
- Subjects with history of grade 3 toxicity with prior immunotherapy
- Patients with distant metastases
- Subjects with active autoimmune disease
- Breastfeeding women
- Additional prior malignancy within the previous 3 years (treated or untreated, except for skin carcinomas treated with excision alone and carcinoma in situ of the cervix)
- Palliative radiotherapy less than 14 days prior to first dose of study drug
- Any history of hypersensitivity to any of the trial medications
- Poorly controlled or serious medical or psychiatric illness likely to interfere with participation and/or compliance in this clinical trial
- Prisoners or subjects who are involuntarily incarcerated
- Patients not available for follow-up/future contact as defined in the ICF
- Note: Patients on this protocol are not excluded from participation in other clinical trials
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04754321
Start Date
May 12 2022
End Date
December 31 2025
Last Update
September 29 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210