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New treatment option for Head and Neck Carcinoma of Unknown Primary
Official title Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer
ClinicalTrials.gov ID: NCT04754321
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck carcinoma of unknown primary.
Also referred to as Keytruda, Lambrolizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically confirmed either persistent and/ or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck...
- 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
You likely can't join if
- 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...
- Unresectable disease, as determined by the surgeon and team
- people with history of grade 3 toxicity with prior immunotherapy
See the full eligibility criteria
- 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 =\ = 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 people 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...
- 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...
- Unresectable disease, as determined by the surgeon and team
- people with history of grade 3 toxicity with prior immunotherapy
- Patients with distant metastases
- people 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 people 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.