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Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC). | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).

NCT06448026•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

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

Detailed Description

Primary Objective: \- To assess the efficacy of cemiplimab and cetuximab in patients with recurrent oral cavity squamous cell carcinoma Secondary Objective: * To assess safety of cemiplimab and cetuximab prior salvage surgery * To evaluate the efficacy of cemiplimab and cetuximab prior salvage surgery on measures * To estimate the one-year disease free survival (DFS) * To estimate the median overall survival (OS) Tertiary/Exploratory Objective: * 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants ≥18 years with histology-proven recurrent oral cavity squamous cell carcinoma.
•2. Amenable to salvage surgery
•3. Disease recurrence at least 3 months after completion of curative-intent therapy (including surgery, post operatory radiation, and/or chemotherapy)
•4. Measurable disease per RECIST 1.1
•5. Performance status ECOG of 0 or 1
•6. Willing to undergo baseline (if archival tumor specimen is not available) and on-treatment biopsy for correlative studies
•7. Laboratory measurements, blood counts:
•2. Absolute neutrophil count ≥ 1 x 109/mL
•3. Platelets ≥ 80 x 109/mL
•8. Laboratory measurements, renal function:
+6 more criteria

Exclusion Criteria

•1. Disease recurrence within 3 months after completion of definitive treatment (including surgery, post operatory, systemic therapy)
•2. Distant metastatic disease (M1), visceral and/or distant nodal
•3. Any prior treatment with an anti-PD1/PD-L1 agent
•4. Participants 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.
•5. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
•Exceptions: Participants 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.
•6. 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.
•7. Recipient of a solid organ transplant (other than corneal transplants)
•8. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation
+11 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

November 21, 2024

Primary Completion Date

May 15, 2027

Completion Date

May 15, 2027

Last Updated

December 5, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Recurrent Oral Cavity Squamous Cell Carcinoma

Interventions

Cemiplimab

DRUG

Cetuximab

DRUG

Contacts

Renata Ferrarotto, MD

CONTACT

713-745-6774 rferrarotto@mdanderson.org