Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity and HPV-negative Oropharyngeal Squamous Cell Carcinoma

NCT06448026 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-0053NCI-2024-04824
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.

Conditions

Locally Recurrent Oral Cavity Squamous Cell Carcinoma

Keywords

local recurrence; oral cavity cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year

Study Arms (1)

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.

Drug: Cemiplimab; Drug: Cetuximab

Interventions

Cetuximab DRUG

Given by IV

Cemiplimab + Cetuximab

Cemiplimab DRUG

Given by IV

Cemiplimab + Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify 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)
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

cemiplimab; Cetuximab

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Luana Guimaraes De Sousa, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luana Guimaraes De Sousa, MD

CONTACT

713-7921256; lgsousa@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-06

Locations

US (1)