Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamou… (NCT04862650) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
United States46 participantsStarted 2021-11-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 contrace…