Locally Recurrent Oral Cavity Squamous Cell CarcinomaPhase 2NCT06448026
Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity and HPV-negative Oropharyngeal Squamous Cell Carcinoma
A Phase 2 study testing Cemiplimab and Cetuximab in people with Locally Recurrent Oral Cavity Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Recurrent Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- Cemiplimab and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 15 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Luana Guimaraes De Sousa, MD, lgsousa@mdanderson.org
Luana Guimaraes De Sousa, MD
About this study
To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.
Read the detailed description
Primary Objective:
- Primary Objectives To evaluate the clinical efficacy, defined as overall response rate, of cemiplimab combined with cetuximab in patients with recurrent oral cavity and HPV-negative oropharynx squamous cell carcinoma.
Secondary Objective:
-To evaluate other markers of clinical efficacy (pathological response rates, objective response rate per RECIST, overall survival) and safety.
Exploratory Endpoints
- To explore patient-reported outcomes (PRO) during CC and following salvage surgical resection
- Assess impact of cemiplimab and cetuximab on surgery and adjuvant therapy
- To explore biomarkers that may predict response to therapy
- Being tested
- Cemiplimab, Cetuximab
- Keywords
- local recurrence, oral cavity cancer
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Given by IV
CetuximabDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab + Cetuximab | Experimental | Participants will receive cemiplimab and cetuximab together for 6 weeks, and then you will have salvage surgery. Based on how the tumor responds to the study therapy, you may also receive cemiplimab alone for up to 1 year after surgery. Receives: Drug: Cemiplimab; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start21 Nov 2024
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent Oral Cavity Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Luana Guimaraes De Sousa, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448026
- Sponsor's protocol ID
- 2024-0053
- Other IDs
- NCI-2024-04824
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2024-0053
- Keywords
- local recurrence, oral cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.
Detailed description
Primary Objective:
- Primary Objectives To evaluate the clinical efficacy, defined as overall response rate, of cemiplimab combined with cetuximab in patients with recurrent oral cavity and HPV-negative oropharynx squamous cell carcinoma.
Secondary Objective:
-To evaluate other markers of clinical efficacy (pathological response rates, objective response rate per RECIST, overall survival) and safety.
Exploratory Endpoints
- To explore patient-reported outcomes (PRO) during CC and following salvage surgical resection
- Assess impact of cemiplimab and cetuximab on surgery and adjuvant therapy
- To explore biomarkers that may predict response to therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab + Cetuximab | Experimental | Drug: Cemiplimab, Drug: CetuximabParticipants will receive cemiplimab and cetuximab together for 6 weeks, and then you will have salvage surgery. Based on how the tumor responds to the study therapy, you may also receive cemiplimab alone for up to 1 year after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabGiven by IV | Drug | Cemiplimab + Cetuximab |
| CetuximabGiven by IV | Drug | Cemiplimab + Cetuximab |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luana Guimaraes De Sousa, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab and Cetuximab in people with Locally Recurrent Oral Cavity Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luana Guimaraes De Sousa, MD (713-7921256, lgsousa@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.