Is NCT06448026 recruiting in Houston, TX?

Yes, NCT06448026 is currently recruiting participants at its Houston, TX location. This locally recurrent oral cavity squamous cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Houston 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.

Locally Recurrent Oral Cavity Squamous Cell Carcinoma Clinical Trial in Houston, TX

Q: How do I join the locally recurrent oral cavity squamous cell carcinoma clinical trial in Houston?

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

Who Can Participate

Inclusion Criteria

Subjects .18 years with histology-proven locoregionally recurrent oral cavity squamous cell carcinoma or HPV-negative OPSCC

HPV testing is required only in oropharyngeal sites and must be negative

Amenable to salvage surgery

Disease recurrence at least 3 months after completion of curative-intent therapy, which must include at least surgery and post operatory radiation. Previous systemic therapy is the curative-setting is not required but allowed (e.g., neoadjuvant chemotherapy, concurrent chemotherapy).

Measurable disease per RECIST 1.1

Performance status ECOG of 0 or 1

Willing to undergo baseline (if archival tumor specimen is not available) and on-treatment biopsy for correlative studies

Laboratory measurements, blood counts:

Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria

Absolute neutrophil count ≥ 1 x 109/mL

Platelets ≥ 80 x 109/mL

Laboratory measurements, renal function: a) Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation

Laboratory measurements, hepatic function:

AST and ALT ≤ 3 x ULN

Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN and primarily unconjugated if subject has a documented history of Gilbert's syndrome or genetic equivalent.

Female subjects with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 120 days after completion of study therapy. The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).

Male participants who are sexually active with women with reproductive potential must agree to use contraception for the duration of treatment and for at least 90 days after completion of study therapy.

Exclusion Criteria

Disease recurrence within 3 months after completion of definitive treatment (including surgery, post operatory, systemic therapy)

Distant metastatic disease (M1), visceral and/or distant nodal

Prior treatment with an t immune checkpoint inhibitor agent in the curative setting is allowed if over 1 year from the date of completion (last dose)

Subjects with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug. Exceptions: Physiologic replacement doses are allowed even if they are \>10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.

Subjects with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date. Exceptions: Subjects with vitiligo, type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that has resolved, or psoriasis that does not require systemic treatment are permitted.

History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.

Recipient of a solid organ transplant (other than corneal transplants)

Prior allogeneic stem cell transplantation, or autologous stem cell transplantation

History of previous malignancy other than malignancy treated with curative intent within less than 5 years. Participants with the following diagnoses represents an exception and may enroll if ≥ 1 year with no evidence of active disease before the first dose of the study drug:

Locally advanced non-melanoma skin cancers with no current evidence of disease

Melanoma in situ with no current evidence of disease

Localized cancer of the prostate with prostate-specific antigen of \<1 ng/mL

Treated or localized well-differentiated thyroid cancer

Treated cervical carcinoma in situ

Treated ductal/lobular carcinoma in situ of the breast

Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 10 days prior to administration of cemiplimab and cetuximab. Subjects with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study if the viral load is undetectable at screening.

Disease or medical conditions that would substantially increase the risk-benefit ratio of participating in the study that include acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV

Female participants who are pregnant or breast-feeding

Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient

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 Houston?

Yes, this clinical trial (NCT06448026) has an active research site in Houston, TX 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.

Locally Recurrent Oral Cavity Squamous Cell Carcinoma Treatment Options in Houston, TX

If you're searching for locally recurrent oral cavity squamous cell carcinoma treatment options in Houston, TX, this clinical trial (NCT06448026) 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 Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced locally recurrent oral cavity squamous cell carcinoma 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 locally recurrent oral cavity squamous cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Locally Recurrent Oral Cavity Squamous Cell Carcinoma Clinical Trial in Houston, TX

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