Is NCT07460765 recruiting in Nashville, TN?

Yes, NCT07460765 is currently recruiting participants at its Nashville, TN location. This hnscc clinical trial is actively enrolling qualified participants.

How do I join the hnscc clinical trial in Nashville?

To join this clinical trial in Nashville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Nashville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Hnscc Clinical Trial in Nashville, TN

About This Hnscc Study in Nashville

The goal of this Phase 1 clinical trial is to evaluate the safety and feasibility of nivolumab-IRDye800CW (nivo800) as a molecular imaging agent in adults with biopsy-confirmed or presumed head and neck squamous cell carcinoma (HNSCC) who are scheduled to undergo standard-of-care surgical resection. The main questions it aims to answer are: * Is nivolumab-IRDye800CW (nivo800) safe when administered before surgery, as measured by the occurrence of clinically significant Grade ≥2 adverse events that are possibly, probably, or definitely related to the study drug? * What is the extent of pathological response at each dose level, including residual viable tumor, fibrosis, necrosis, and tumor-infiltrating lymphocyte characteristics? Participants will: * Receive two intravenous infusions during the preoperative period, approximately 2-3 weeks before surgery and again 1-2 days before surgery. * Undergo standard-of-care surgical resection with collection of tumor and lymph node specimens for pathological and imaging studies.

Sponsor: Vanderbilt-Ingram Cancer Center

Who Can Participate

Inclusion Criteria

Written informed consent

Age ≥ 18 years

Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.

Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).

Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2.

Exclusion Criteria

Patients not planning for SOC surgical resection

Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:

Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.

Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.

Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:

Rash must cover \< 10% of body surface area

Disease is well controlled at baseline and requires only low-potency topical corticosteroids

No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months

History of hepatitis C that has not been treated with curative intent.

History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan on active systemic therapy.

History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.

Severe unresolved infection within 4 weeks prior to initiation of study treatment.

Prior allogeneic stem cell or solid organ transplantation.

History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\>10 mg/day of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:

Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.

Physiologic corticosteroid replacement therapy at doses ≤ 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.

Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if \>30 days from first infusion.

Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.

Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.

Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study drug administration.

Participants presenting with a baseline QTcF interval \> than 480 milliseconds.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Nashville?

Yes, this clinical trial (NCT07460765) has an active research site in Nashville, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hnscc Treatment Options in Nashville, TN

If you're searching for hnscc treatment options in Nashville, TN, this clinical trial (NCT07460765) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Nashville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hnscc specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hnscc clinical trials near you to find additional studies recruiting in your area.

Hnscc Clinical Trial in Nashville, TN

Expert Care in Nashville

IRB Approved

No-Cost Care

Apply for This Nashville Location

Why Participate?

Simple Process