Status:
ACTIVE_NOT_RECRUITING
Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Marcelo Bonomi
Conditions:
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Metastatic Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (...
Detailed Description
PRIMARY OBJECTIVE: I. To assess the overall response rate (ORR) at 12 weeks of treatment with the treatment combination cemiplimab, paclitaxel, and carboplatin. SECONDARY OBJECTIVES: I. To assess t...
Eligibility Criteria
Inclusion
- Recurrent/metastatic (R/M) SCCHN of the oral cavity, oropharynx, larynx and hypopharynx
- No prior systemic therapy for treatment of R/M disease
- Patients with squamous cell carcinoma of an unknown primary are eligible provided their tumor tested positive for p-16 and they have previously received treatment for locoregional head and neck cancer
- Must be at least four weeks since prior radiation and/or surgery
- Must be at least four weeks from curative intent systemic therapy. Of note: patients who have received up to two courses of chemoradiotherapy (CRT) for locoregionally advanced disease are eligible. Induction chemotherapy will not be considered a separate line of therapy
- At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)
- 18 years of age and older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- White blood cell (WBC) count \> 2,500 cells/uL
- Absolute neutrophil count (ANC) \>1,500 cells/uL
- Platelet count \>= 100,000 cells/uL
- Hemoglobin \>= 9 g/dL
- Creatinine =\< 1.6 mg/dL
- Total bilirubin =\< 1.6 mg/dL
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase \[AST\]), serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x upper limit of normal (ULN)
- Potassium \>= lower limit of normal (LLN)
- Willingness to use medically acceptable contraception throughout the study period and four months after the final administration of treatment
- For female subjects with reproductive potential: a negative serum pregnancy test at baseline
- Ability and willingness to provide written informed consent and to comply with the study visits and assessment schedule
Exclusion
- Disease amenable to curative local therapy
- Nasopharyngeal, salivary gland, lip, or sinonasal carcinoma
- Disease that requires corticosteroids or other ongoing immunosuppressive treatment
- Previous treatment with mAb-based immunotherapy for treatment of prior oncologic treatment
- Previous treatment with PI3K inhibitors
- Known brain metastases, unless stable for at least 21 days prior to registration
- Known infection human immunodeficiency virus (HIV), hepatitis B or C
- Clinically significant cardiac disease (e.g., congestive heart failure, unstable or uncontrolled angina, myocardial infarction) within the past six months
- History of pneumonitis within the past five years
- Recipient of live vaccines (including attenuated) within 30 days of planned study treatment
- Female patients who are pregnant or breast-feeding
- Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements or otherwise compromise the study's objectives in the opinion of the Principal Investigator
Key Trial Info
Start Date :
November 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04862650
Start Date
November 30 2021
End Date
December 31 2025
Last Update
July 10 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210