Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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 (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marcelo Bonomi
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cemiplimab; Paclitaxel

Criteria

Inclusion Criteria:

• 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 systemic therapy, radiation and/or surgery

• 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 weeks 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 Criteria:

• Disease which is amenable to curative local therapy

• Nasopharyngeal, salivary gland, lip, or sinonasal carcinoma

• Disease that requires corticosteroids (>10 mg prednisone or equivalent daily within four weeks prior to the first dose of cemiplimab) or other immune suppressives at baseline

• Previous treatment with mAb-based immune therapies

• 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 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