Actively Recruiting
Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).
Led by M.D. Anderson Cancer Center · Updated on 2025-12-05
17
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.
CONDITIONS
Official Title
Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with histology-confirmed recurrent oral cavity squamous cell carcinoma
- Disease suitable for salvage surgery
- Disease recurrence at least 3 months after completing curative-intent therapy including surgery, radiation, or chemotherapy
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Willingness to undergo baseline and on-treatment biopsy if no archival tumor specimen is available
- Hemoglobin level of 9 g/dL or higher (blood transfusions allowed to meet this level)
- Absolute neutrophil count of 1 x 10^9/mL or higher
- Platelet count of 80 x 10^9/mL or higher
- Creatinine clearance of 30 mL/min or higher assessed by Cockcroft-Gault equation
- AST and ALT liver enzymes no greater than 3 times the upper limit of normal
- Total bilirubin no greater than 1.5 times the upper limit of normal, or up to 3 times if history of Gilbert's syndrome
- Female participants with reproductive potential must use two effective contraceptive methods during treatment and for 90 days after
- Male participants sexually active with women of reproductive potential must use contraception during treatment and for 90 days after
You will not qualify if you...
- Disease recurrence less than 3 months after finishing definitive treatment
- Presence of distant metastatic disease including visceral or distant lymph nodes
- Previous treatment with anti-PD1 or anti-PD-L1 agents
- Need for corticosteroid therapy greater than 10 mg prednisone daily within 14 days before first study dose (exceptions for physiologic replacement doses and certain inhaled or topical steroids)
- Active or suspected autoimmune disease requiring systemic therapy within 5 years (exceptions include vitiligo, type 1 diabetes, certain endocrinopathies, resolved childhood asthma, or psoriasis not requiring systemic treatment)
- History of interstitial lung disease or immune-related pneumonitis requiring immunosuppressive glucocorticoids
- Prior solid organ transplant except corneal transplant
- Prior allogeneic or autologous stem cell transplant
- History of previous malignancy within 5 years except certain treated cancers with no active disease
- Active uncontrolled infection requiring systemic therapy within 10 days before treatment (HIV, hepatitis B or C allowed if viral load undetectable)
- Medical conditions increasing risk such as recent heart attack, unstable angina, uncontrolled diabetes, significant infections, or severe heart failure
- Pregnant or breastfeeding females
- Known allergy to study drugs or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Renata Ferrarotto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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