The aim of this research study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab, with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers. The names of the study drugs used in this research study are: * Toripalimab (a type of monoclonal antibody) * Carboplatin (a type of antineoplastic agent) * Docetaxel (a type of antineoplastic agent) * Cisplatin (a type of antineoplastic agent)
This single-arm, open-label, single-center phase II study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers. Toripalimab binds to the PD-1 receptors on T-cells (immune cells) and prevents them from interacting with PD-L1 and PD-L2 on tumor cells. This stimulates the immune system to fight tumor cells. The U.S. Food and Drug Administration (FDA) has not approved Toripalimab for sinonasal cancers, but it has been approved for another type of head and neck cancer called nasopharyngeal carcinoma (NPC), in the advanced incurable setting when surgery is no longer possible, or when cancer has spread to parts of the body outside the head and neck region. Carboplatin and Docetaxel have been approved by the FDA in the advanced incurable setting for other types of head and neck cancer. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, X-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, and photographic images of tumors. It is expected that about 20 people will take part in this research study. Coherus Biosciences, a pharmaceutical company, is funding this research study by providing the study drug and funding for the research study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
An anti-PD-1 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.
An antineoplastic agent, multi-dose vials, via intravenous (into the vein) infusion per standard of care.
A taxoid antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.
per standard of care
An antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGPathologic Treatment Response Rate (pTRR)
pTRR is defined as the proportion of participants that experience a complete pathologic response or partial pathologic response during treatment, as defined in the RECIST criteria.
Time frame: Tumor assessments or scans will be obtained at baseline and 3-months following the end of treatment. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined in protocol section 5.10.
Incidence of Adverse Events [Safety and Tolerability]
Safety and tolerability assessed by CTCAE v5.0 and summarized descriptively.
Time frame: Adverse events are collected every study visit through study completion, an average of 1 year. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined in protocol section 5.10.
Median Disease-free Survival (DFS)
Disease-free survival (PFS) is defined as the time from the date of study registration to first invasive local, regional, distant recurrence, or death due to any cause. Participants alive without disease are censored at date of last disease evaluation.
Time frame: Tumor assessments or scans will be obtained at baseline and 3-months following the end of treatment. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined in protocol section 5.10.
Median Overall Survival (OS)
OS is Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
Time frame: Participants will be followed for 1-year (12 months) after completion or removal from protocol therapy or until death, whichever occurs first. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined
Organ Preservation Rate
Defined as the percentage of patients with an intact orbit, palate, and skull base immediately post-op from definitive oncologic resection among the study cohort.
Time frame: Up to 42 days.
Overall Response Rate (ORR)
ORR is the proportion of participants that experience complete response (CR) or partial response (PR) recorded from the start of the TCD treatment to the first imaging just prior to surgery.
Time frame: Up to 42 days.
Correlation between tumor PD-L1 combined positive score (CPS) with pTR
PD-L1 CPS values range from 0-100. Higher scores are considered positive.
Time frame: Tumor assessments or scans will be obtained at baseline and 3-months following the end of treatment. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined in protocol section 5.10
Correlation between tumor PD-L1 combined positive score (CPS) with survival outcomes
PD-L1 CPS values range from 0-100. Higher scores are considered positive.
Time frame: Participants will be followed for 1-year (12 months) after completion or removal from protocol therapy or until death, whichever occurs first. Treatment duration is not fixed and this observation time is variable per protocol.
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