Head and Neck CancerPhase 1NCT07501650
Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer
A Phase 1 study testing Pembrolizumab, Definity and Ultrasound-Induced Microbubble Cavitation in people with Head and Neck Cancer and Head and Neck Small Cell Carcinoma, run by Thomas Jefferson University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Small Cell Carcinoma, Metastatic Head and Neck Cancer
- What is being tested?
- Pembrolizumab, Definity and Ultrasound-Induced Microbubble Cavitation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must meet all of the following inclusion criteria 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.
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- 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 subjects 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 study drugs.
- 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 experienced menarche and who has not undergone surgical sterilization (hysterectomy, tubal ligation, or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
- 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 be instructed to adhere to contraception for 90 days after the last dose of study drugs. Men who are azoospermic do not require contraception.
- Informed Consent: All subjects must be able to comprehend and sign a written informed consent document.
Who cannot join
- 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
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- 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 in situ cervical cancer that has undergone potentially curative therapy. Patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 2 years post-diagnosis.
- 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 be evaluated on a caseby-case basis after consultation with the Study Physician. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with anti-PD-1 therapy may be included only after consultation with the Study Physician.
- Any subjects 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 prior history of allogenic organ transplantation.
- 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, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- 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 plus Definity.
- 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 lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- 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 surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc]and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCVRNA.
- Any untreated metastasis(es) to the brain that may be considered active.
- History of pneumonitis within the past 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Joseph Curry, MD, 215-600-9151, ONCTrialNow@jefferson.edu
About this study
Official title: Feasibility Trial of Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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. Following each infusion, ultrasound will be directed at the primary tumor site to induce microbubble cavitation, with the goal of tumor sonoporation. The primary endpoints will be feasibility, measured based on successful recruitment of 6 participants within 1 year of initiating recruitment, with successful completion of trial procedures among at least 80 percent of patients. Secondary endpoints will include proportion of serious adverse events, clinical/radiographic response, overall survival, and progression-free survival.
Read the detailed description
The proposed study is a feasibility trial of Pembrolizumab plus Definity Perflutren Lipid Microsphere (Lantheus Medical Imaging), followed by ultrasound-induced microbubble cavitation (UC), which will target patients with R/M HNSCC, for which Pembrolizumab is already indicated as standard of care treatment. Patients will undergo up to 3 cycles of therapy. Participants may continue study treatment for up to 3 cycles, 3 weeks apart, from the time of initiating treatment, with 3-month safety follow-up.
Participant characteristics and endpoints will be summarized through appropriate descriptive statistics-the mean and standard deviation (or median and interquartile range, if appropriate) for continuous variables, and frequency counts and percentages for categorical variables.
Primary Analysis Among all patients enrolled, feasibility will be assessed, defined as enrollment of 6 participants within 1 year of study initiation, and completion of all trial procedures, including 3 cycles of PD treatment and follow-up visits, among at least 80 percent of enrolled patients.
Recruitment feasibility (primary objective secondary endpoint) will be assessed as the number of participants enrolled during the first 12 months from site activation. Success is defined as 6 participants enrolled within this window. The investigators will summarize the 6-month enrollment count and accrual rate descriptively. Protocol completion feasibility (primary objective primary endpoint) will be assessed as the proportion of enrolled participants who complete all pre-specified trial procedures (all scheduled visits/assessments through end-of-treatment and the primary follow-up time point). The denominator is all enrolled participants. Unknown or missing completion status will be counted as not complete. Success is defined as at least 80 percent completion. The investigators will report the completion proportion with 95 percent exact binomial (Clopper-Pearson) confidence intervals.
Secondary Analysis Assessment of the following secondary metrics is anticipated using descriptive statistics; no hypothesis tests are planned. Where applicable, 95% exact binomial CIs (Clopper-Pearson) will be provided for proportions.
- Proportion of serious adverse events (according to CTCAEv5.0)
- Objective Response Rate (Clinical/Radiographic Response)
- Progression Free Survival
- Overall Survival
Exploratory/Correlative Analysis/Assessments Assessment of the following correlative metrics through descriptive statistics is anticipated. No hypothesis tests are planned.
- IHC measures of the prevalence of intratumoral immune cell populations including but not limited to CD8, CD45, FoxP3, PD-L1
- IHC-based measures of myeloid lineage differentiation markers:CD3, CD4, CD8, CD11b, CD11c, CD14, CD33, CD163, CD204, and HLA-DR, also analyzed with flow cytometry
- Luminex panel of inflammatory markers with the Milliplex MAP Human Cytokine/chemokine kit
- Variant files (VCFs) including point mutations, insertions, and deletions, as well as HLA-type, identified from whole exome sequencing
- Epitope analysis of neoantigens and HLA typing using RNAseq
- Spatially-resolved, digital quantitation of mRNA using Nanostring GeoMx DSP
- Quantitative-CEUS parameters collected during treatment infusion, correlated with treatment efficacy and TME parameters
Interim Analyses and Stopping Rules The study will be discontinued if there are more than 2 "study-limiting adverse events" at any point during the trial, with a "study-limiting adverse event" being defined as any grade 3 or higher cardiac, endocrine, or immunologic adverse event, or any grade 4 or higher adverse event.
- Conditions
- Head and Neck Cancer, Head and Neck Small Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
- Being tested
- Pembrolizumab, Definity, Ultrasound-Induced Microbubble Cavitation
- Keywords
- Recurrent, Pembrolizumab, Pembro, Microbubble, Cavitation
- Medical subject headings
- Head and Neck Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks for up to 3 cycles
DefinityDrug
Also called Definity RT, perflutren lipid microsphere
Definity will be administered intravenously during each treatment cycle to facilitate ultrasound-induced microbubble cavitation.
Ultrasound-Induced Microbubble CavitationDevice
Also called Therapeutic Ultrasound
Therapeutic Ultrasound will be applied to the tumor site during and following the Definity infusion to induce microbubble cavitation using modified ultrasound parameters.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation | Experimental | Treatment will be administered on an outpatient basis. 200 mg Pembrolizumab + 3 mL Definity infusions will be administered by nurses at Thomas Jefferson University every 3 weeks for up to 3 cycles. The first cycle will take 60 minutes, while the subsequent infusions should take half an hour to complete. Receives: Drug: Pembrolizumab; Drug: Definity; Device: Ultrasound-Induced Microbubble Cavitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who complete all planned treatment cycles
The number of participants who completed trial procedures among at least 80 percent of patients, among patients with recurrent or metastatic head and neck squamous cell carcinoma.
Measured: Up to 9 weeks
Secondary outcomes (5)
Number of Treatment-Related Adverse Events (TRAEs)
Number of adverse events related to study treatment, assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Up to 6 months post-treatment
Objective Response Rate using RECIST v1.1
Objective Response Rate (ORR) will be assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). The number of participants who achieve a Complete Response (CR)-disappearance of all target lesions, Partial Response (PR)-at least a 30% reduction in tumor size from baseline, Progressive Disease (PD)--At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and Stable Disease (SD)--Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, will be reported. ORR measured using the RECISTv1.1 criteria or assessment of clinical and pathologic response.
Measured: Up to 3 months after last treatment
Overall Survival
Time from treatment start until death from any cause.
Measured: 90 days after last dose
Disease-Free Survival
Time from treatment start until recurrence of disease or death from any cause, whichever occurs first.
Measured: 90 days after last dose
Progression-Free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start18 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Responsible party
- Sponsor
- Investigators
- Joseph M Curry, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501650
- Sponsor's protocol ID
- iRISID-2025-0984
- Other IDs
- JT 45752
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07501650
- Acronym / sponsor ID
- iRISID-2025-0984
- Conditions
- Head and Neck Cancer, Head and Neck Small Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
- Keywords
- Recurrent, Pembrolizumab, Pembro, Microbubble, Cavitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Following each infusion, ultrasound will be directed at the primary tumor site to induce microbubble cavitation, with the goal of tumor sonoporation. The primary endpoints will be feasibility, measured based on successful recruitment of 6 participants within 1 year of initiating recruitment, with successful completion of trial procedures among at least 80 percent of patients. Secondary endpoints will include proportion of serious adverse events, clinical/radiographic response, overall survival, and progression-free survival.
Detailed description
The proposed study is a feasibility trial of Pembrolizumab plus Definity Perflutren Lipid Microsphere (Lantheus Medical Imaging), followed by ultrasound-induced microbubble cavitation (UC), which will target patients with R/M HNSCC, for which Pembrolizumab is already indicated as standard of care treatment. Patients will undergo up to 3 cycles of therapy. Participants may continue study treatment for up to 3 cycles, 3 weeks apart, from the time of initiating treatment, with 3-month safety follow-up.
Participant characteristics and endpoints will be summarized through appropriate descriptive statistics-the mean and standard deviation (or median and interquartile range, if appropriate) for continuous variables, and frequency counts and percentages for categorical variables.
Primary Analysis Among all patients enrolled, feasibility will be assessed, defined as enrollment of 6 participants within 1 year of study initiation, and completion of all trial procedures, including 3 cycles of PD treatment and follow-up visits, among at least 80 percent of enrolled patients.
Recruitment feasibility (primary objective secondary endpoint) will be assessed as the number of participants enrolled during the first 12 months from site activation. Success is defined as 6 participants enrolled within this window. The investigators will summarize the 6-month enrollment count and accrual rate descriptively. Protocol completion feasibility (primary objective primary endpoint) will be assessed as the proportion of enrolled participants who complete all pre-specified trial procedures (all scheduled visits/assessments through end-of-treatment and the primary follow-up time point). The denominator is all enrolled participants. Unknown or missing completion status will be counted as not complete. Success is defined as at least 80 percent completion. The investigators will report the completion proportion with 95 percent exact binomial (Clopper-Pearson) confidence intervals.
Secondary Analysis Assessment of the following secondary metrics is anticipated using descriptive statistics; no hypothesis tests are planned. Where applicable, 95% exact binomial CIs (Clopper-Pearson) will be provided for proportions.
- Proportion of serious adverse events (according to CTCAEv5.0)
- Objective Response Rate (Clinical/Radiographic Response)
- Progression Free Survival
- Overall Survival
Exploratory/Correlative Analysis/Assessments Assessment of the following correlative metrics through descriptive statistics is anticipated. No hypothesis tests are planned.
- IHC measures of the prevalence of intratumoral immune cell populations including but not limited to CD8, CD45, FoxP3, PD-L1
- IHC-based measures of myeloid lineage differentiation markers:CD3, CD4, CD8, CD11b, CD11c, CD14, CD33, CD163, CD204, and HLA-DR, also analyzed with flow cytometry
- Luminex panel of inflammatory markers with the Milliplex MAP Human Cytokine/chemokine kit
- Variant files (VCFs) including point mutations, insertions, and deletions, as well as HLA-type, identified from whole exome sequencing
- Epitope analysis of neoantigens and HLA typing using RNAseq
- Spatially-resolved, digital quantitation of mRNA using Nanostring GeoMx DSP
- Quantitative-CEUS parameters collected during treatment infusion, correlated with treatment efficacy and TME parameters
Interim Analyses and Stopping Rules The study will be discontinued if there are more than 2 "study-limiting adverse events" at any point during the trial, with a "study-limiting adverse event" being defined as any grade 3 or higher cardiac, endocrine, or immunologic adverse event, or any grade 4 or higher adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation | Experimental | Drug: Pembrolizumab, Drug: Definity, Device: Ultrasound-Induced Microbubble CavitationTreatment will be administered on an outpatient basis. 200 mg Pembrolizumab + 3 mL Definity infusions will be administered by nurses at Thomas Jefferson University every 3 weeks for up to 3 cycles. The first cycle will take 60 minutes, while the subsequent infusions should take half an hour to complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
Key exclusion criteria (22 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks for up to 3 cycles | Drug | Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation |
| DefinityAlso: Definity RT, perflutren lipid microsphereDefinity will be administered intravenously during each treatment cycle to facilitate ultrasound-induced microbubble cavitation. | Drug | Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation |
| Ultrasound-Induced Microbubble CavitationAlso: Therapeutic UltrasoundTherapeutic Ultrasound will be applied to the tumor site during and following the Definity infusion to induce microbubble cavitation using modified ultrasound parameters. | Device | Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation |
Primary outcome
Number of Participants who complete all planned treatment cycles
Time frame: Up to 9 weeks
The number of participants who completed trial procedures among at least 80 percent of patients, among patients with recurrent or metastatic head and neck squamous cell carcinoma.
5 secondary outcomes
Number of Treatment-Related Adverse Events (TRAEs)
Time frame: Up to 6 months post-treatment
Objective Response Rate using RECIST v1.1
Time frame: Up to 3 months after last treatment
Overall Survival
Time frame: 90 days after last dose
Disease-Free Survival
Time frame: 90 days after last dose
Progression-Free Survival
Time frame: 90 days after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph M Curry, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pembrolizumab, Definity and Ultrasound-Induced Microbubble Cavitation in people with Head and Neck Cancer and Head and Neck Small Cell Carcinoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Site Public Contact (215-600-9151, ONCTrialNow@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who complete all planned treatment cycles (time frame: Up to 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.