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New treatment option for Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Official title Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity and HPV-negative Oropharyngeal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06448026
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally recurrent oral cavity squamous cell carcinoma.
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
- To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.
- Phase 2: a mid-size study of how well it works
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
- people .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...
- Measurable disease per RECIST 1.1
You likely can't join if
- 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)
- people with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug...
- people with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date...
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required...
See the full eligibility criteria
- people .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...
- 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 2. 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 people 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...
- 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.
- 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)
- people 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...
- people with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date. Exceptions: people with vitiligo, type I diabetes mellitus, and...
- 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...
- 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. people with known hepatitis B, hepatitis C...
- 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...
- Female participants who are pregnant or breast-feeding
- Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, 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.