Actively Recruiting
Cemiplimab and Cetuximab Before Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
17
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the use of cemiplimab and cetuximab before salvage surgery in patients with recurrent oral cavity squamous cell carcinoma. The study aims to assess how effective these drugs are in controlling the disease, along with their safety, impact on surgery and additional therapies, and patient-reported outcomes. The research also explores biomarkers that might predict how well patients respond to the treatment. Participants will receive cemiplimab and cetuximab together for six weeks prior to salvage surgery. Depending on the tumor's response to the treatment, some participants may continue to receive cemiplimab alone for up to one year following surgery. Both drugs are given intravenously. This phase 2 trial includes only one treatment arm where all participants receive the study drugs before surgery. During the study, participants will be monitored for safety and adverse events for about one year. The research team will collect biopsies at baseline and during treatment for additional studies. They will also assess patient-reported outcomes and track disease-free survival and overall survival. Laboratory tests and performance status evaluations will be conducted to ensure participants meet health requirements. The total involvement includes treatment before surgery and follow-up monitoring afterward.
CONDITIONS
Brief 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...
- 18 years or older with histology-confirmed recurrent oral cavity squamous cell carcinoma
- Eligible for salvage surgery
- Disease recurrence at least 3 months after completing curative-intent therapy
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Willing to undergo baseline and on-treatment biopsy if archival tumor tissue is unavailable
- Hemoglobin level 9 g/dL or higher (transfusions allowed to meet this)
- 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
- AST and ALT levels no more than 3 times the upper limit of normal
- Total bilirubin no more than 1.5 times upper limit of normal, or up to 3 times with Gilbert's syndrome
- Women with reproductive potential must use two effective contraceptive methods during treatment and for 90 days after
- Men 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 within 3 months after definitive treatment
- Distant metastatic disease including visceral or distant lymph nodes
- Prior treatment with anti-PD1 or anti-PD-L1 agents
- Need for corticosteroid therapy over 10 mg prednisone/day within 14 days before treatment (except physiologic doses)
- Active or suspected autoimmune disease requiring systemic therapy within 5 years, except specified exceptions
- History of interstitial lung disease or active pneumonitis requiring immunosuppressive glucocorticoids
- Recipient of solid organ transplant (except corneal)
- Prior stem cell transplantation
- History of other malignancies within 5 years except specified low-risk cancers
- Active uncontrolled infection needing systemic antimicrobial treatment within 10 days before study
- Serious medical conditions increasing risk, including recent heart attack, unstable angina, uncontrolled diabetes, serious infections, or severe heart failure
- Pregnant or breastfeeding women
- Known allergy to study drugs or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive cemiplimab and cetuximab together for 6 weeks prior to salvage surgery.
Weekly visits for 6 weeks
Duration - Up to 1 week
Participants undergo salvage surgery following the initial treatment phase.
1 visit for surgery and several post-operative visits
Duration - Up to 1 year
Based on tumor response, participants may receive cemiplimab alone for up to 1 year after surgery.
Regular visits during treatment as determined by the study team
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Renata Ferrarotto, MD
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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