The goal of this clinical trial is to learn if the drug Toripalimab can prime the tumor to optimize response to Paclitaxel in HNSCC patients with a decrease performance status in a way that make both drugs well tolerated and improve partial or complete response rate over each treatment. The main questions it aims to answer are:
* What is the response rate of the cancer to paclitaxel after priming with toripalimab * What is the time to progression if we continue to cycle between toripalimab and paclitaxel * What is the impact on the patient's quality of life and overall survival
Participants must have histologically confirmed HNSCC deemed to be metastatic or incurable by the treating physician. Participants can have incurable disease at presentation or have been treated with definitive curable surgical resection, chemoradiotherapy (CRT), or both, then relapsed with non-curable disease. Participants diagnosed with HNSCC stage IV-C or metastatic/non-resectable, relapsed disease are eligible for this study
Participant must have measurable disease, defined by RECIST v1.1.
Participant must be able to understand a written informed consent document and be willing to sign it.
Participants must be 18 years of age or older.
Participants with known untreated brain metastases will be excluded from this clinical trial. Stable brain metastases will be allowed, and it will be confirmed by stable brain MRI with and without contrast within 8 weeks of signing consent.
Participants with uncontrolled chronic obstructive pulmonary disease (COPD), heart disease, or autoimmune disease, in the opinion of the treating physician.
Participants who are taking any other investigational drugs.
Participants who are taking prednisone or equivalent steroid >10 mg per day prior to the start of treatment.
Single group
Toripalimab
DrugToripalimab 240mg intravenously every three weeks on weeks 1, 4 and 7 of a 17 week cycle.
Paclitaxel
DrugPaclitaxel 80mg/m2 intravenously over weekly for 8 weeks on weeks 8-15 of each cycle times 3 cycles
Objective Response Rate (ORR)
The ORR is calculated as the proportion of participants with complete response (CR) or partial response (PR) per RECIST v1.1 among all treated participants. CR is the disappearance of all lesions; PR is at least a 30% decrease in the sum of diameters of target lesions. The two-sided 95% confidence interval (CI) for ORR will be estimated using Clopper-Pearson's method.
Overall Survival (OS)
The OS is the length of time from the start of treatment that participants are still alive. The distribution of OS will be graphically summarized using a Kaplan-Meier (KM) curve with corresponding median and two-sided 95% CIs computed using KM estimates.
Progression Free Survival (PFS)
PFS is defined as the time duration from treatment start to progression or death from any cause, whichever occurs first. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions. The distribution of PFS will be graphically summarized using a KM curve with corresponding median and two-sided 95% CIs computed using KM estimates.
Duration of Response (DOR)
DOR is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. The distribution of DOR will be graphically summarized using a KM curve with corresponding median and two-sided 95% CIs computed using KM estimates.
Impact on Quality of Life (QOL)
QOL will be measured using the Functional Assessment of Cancer Therapy for Head \& Neck cancer (FACT-H\&N). The distribution of QOL will be assessed, and if necessary, a data transformation will be applied to meet normality assumptions. Longitudinal QOL will be summarized using the mean, median, standard deviation (SD), range, and 95% CI across all time points. Minimally important differences (MID) in FACT scores will be determined; for FACT-General the MID is 3 to 7 and for all the subscales the MID is 2 to 3.
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