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New treatment option for Head and Neck Cancer
Official title Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer
ClinicalTrials.gov ID: NCT07501650
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 cancer.
Also referred to as Keytruda.
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 is a feasibility trial studying anti-PD-1 therapy (Pembrolizumab) among patients with R/M HNSCC, delivered with ultrasound-induced microbubble cavitation, with the goal of optimizing delivery of Pembrolizumab and tumor response to Pembrolizumab. Patients will undergo 3 infusions of Pembrolizumab plus Definity 3 weeks apart.
- Phase 1: an early, usually small safety study
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
- Individuals must meet all of the following in order to be eligible to participate in the study:
- Pathologically confirmed, HPV-negative, R/M HNSCC per American Joint Committee on Cancer (AJCC) 8th Edition Staging Criteria, with CPS score \> 1
- The target lesion is ultrasound-accessible, biopsy-accessible, and measurable in at least one dimension, based on RECISTv1.1 criteria.
- Male or female, aged ≥18 years of age
- ECOG Performance status 0-2.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients with HPV-positive or p16-positive SCC
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or antiCTLA-4 antibody
- Any history of allergy to the study drug components, including to polyethyleneglycol or medications containing polyethylene glycol.
- Patients with the following cardiac conditions or history:
- Patients with a known history of anatomic right-to-left, bi-directional, or transient right-to-left cardiac shunts
See the full eligibility criteria
Who can join
- Individuals must meet all of the following in order to be eligible to participate in the study:
- Pathologically confirmed, HPV-negative, R/M HNSCC per American Joint Committee on Cancer (AJCC) 8th Edition Staging Criteria, with CPS score \> 1
- The target lesion is ultrasound-accessible, biopsy-accessible, and measurable in at least one dimension, based on RECISTv1.1 criteria.
- Male or female, aged ≥18 years of age
- ECOG Performance status 0-2.
- Must have a life expectancy of at least 6 months as judged by the treating physician.
- Adequate organ function:
- Absolute neutrophil count 1500/μl or more;
- Platelets 100,000/μl or more,
- Hemoglobin 8 g/dl or more;
- Bilirubin less than or equal to 1.5 x the upper limit of normal (except people with Gilbert syndrome, who can have total bilirubin \<3 mg/dl);
- AST and ALT less than or equal to 2.5x the upper limit of normal
- Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG), which must also be confirmed as negative within 28 days of the start of...
- Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 90 days after the last dose of study drugs. "Women of reproductive potential" is defined as any female who has...
- Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year. Men who are receiving the study medications will...
- Informed Consent: All people must be able to comprehend and sign a written informed consent document.
What rules you out
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients with HPV-positive or p16-positive SCC
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or antiCTLA-4 antibody
- Any history of allergy to the study drug components, including to polyethyleneglycol or medications containing polyethylene glycol.
- Patients with the following cardiac conditions or history:
- Patients with a known history of anatomic right-to-left, bi-directional, or transient right-to-left cardiac shunts
- Patients with NYHA class III or greater heart failure, unstable anginal syndrome, or experiencing active chest pain.
- Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg)
- Patients who have experienced a STEMI or NSTEMI within the last 6 months
- QTc \>500 as determined by Fridericia correction
- Patients with a history of ventricular arrhythmia that has not been corrected by placement of a PPM or ICD
- Any concurrent malignancies: exceptions include- cutaneous basal cell carcinoma, chronic lymphocytic leukemia, melanoma in situ, squamous cell carcinoma of the skin of a secondary location, superficial bladder cancer or...
- Any unresolved toxicity CTCAEv5.0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with Grade ≥2 neuropathy will...
- Any people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 28 days of study drug administration., or a...
- Any active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Patients must not be receiving any other investigational agents; must not have participated in a study of an investigational agent or be using an investigational device within 4 weeks of the first dose of Pembrolizumab...
- Receipt of a live attenuated vaccine within 30 days prior to the first dose of drug on trial.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- Patients must not be pregnant or breastfeeding.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV...
- Any untreated metastasis(es) to the brain that may be considered active.
- History of pneumonitis within the past 5 years.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 Philadelphia, Pennsylvania, 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.