Clinical Trial TitleAn open-label, multi-center trial of SNS-301 added to pembrolizumab in patients with ASPH+ locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck.
National Clinical Trial Number:NCT04034225
Clinical Trial Protocol Description:
There are three purposes of this research study. First, we are evaluating the safety of the treatment we are using. Second, we are evaluating the effects that the treatment has on your immune system. Third, we are evaluating the effect the treatment has on head and neck cancer.
The treatment that we will give you is SNS-301 in addition to Keytruda® (pembrolizumab). To take part in this study, you must currently be receiving Keytruda® or another similar drug call Opdivo® (nivolumab) for at least 12 weeks
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent ASPH+ SCCHN and currently receiving pembrolizumab or nivolumab.
- Have measurable disease, as defined by RECIST version 1.1 (investigator assessment).
- Have a performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Have a life expectancy of ≥ 3 months.
You will be excluded from the study if any of the following criteria apply to you:
- Are undergoing any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0; or if patient has not recovered (i.e., Less than or equal to grade 1 or returned to baseline level) from adverse events due to a previously administered agent; the following exceptions are allowed:
- Palliative radiotherapy for bone metastases or soft tissue lesions should be completed > 7 days prior to baseline imaging.
- Hormone-replacement therapy or oral contraceptives.
- Patients with grade 2 neuropathy or grade 2 alopecia.
- Have evidence of rapid progression or prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
- Are currently participating and receiving trial therapy or has participated in a trial of an investigational agent and/or has used an investigational device within 28 days prior to Day 0.
- Have uncontrolled tumor-related pain.
This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.