Clinical Trial TitleA Phase 2 Study Of ALX 148 In Combination With Pembrolizumab And Chemotherapy In Subjects With Advanced Head And Neck Squamous Cell Carcinoma (Aspen-04)
National Clinical Trial Number:NCT04675333
Clinical Trial Protocol Description:
The purpose of this research study is to study the effectiveness of the study drug, ALX148, in combination with pembrolizumab for treating certain types of head and neck cancer. The study will also assess the safety and tolerability of ALX148 with pembrolizumab, to document the levels of ALX148 in the blood, and to document the effects of ALX148 on the cancer site together with pembrolizumab and chemotherapy.
In this study, subjects will either be given ALX148 in combination with pembrolizumab and chemotherapy or will receive pembrolizumab and chemotherapy alone. The first 6 subjects will receive ALX148 in combination with pembrolizumab and chemotherapy and will have more study visits to look at how ALX148 levels change over time in detail. The purpose of this “safety lead-in” group of subjects is to provide more information about the safety and tolerability of the dose of ALX148 chosen for this study in combination with pembrolizumab and chemotherapy.
After this first group, subjects will be randomly (by chance) assigned to a treatment and will have a 2:1 chance of receiving ALX148 in combination with pembrolizumab and chemotherapy (compared to receiving pembrolizumab and chemotherapy alone.
ALX148 is a new investigational drug. An “investigational” drug is one that is currently not approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied. ALX148 is a fusion protein (a protein generated by joining parts of two different proteins), which has been shown in animal studies to help the immune system destroy cancer cells. The other drug used in this study, pembrolizumab, is approved for treatment of head and neck cancer (and for other cancer types).
More information can be found on the website clinicaltrials.gov by searching for NCT04675333.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) who have not received prior systemic therapy for their advanced disease.
- Have at least one measurable lesion as defined by RECIST version 1.1.
- Meet certain lab requirements to confirm adequate liver, renal, and bone marrow function.
You will be excluded from the study if any of the following criteria apply to you:
- Have disease suitable for local therapy with curative intent.
- Have had systemic anticancer therapy within 4 weeks of starting study treatment.
- Have progressive disease within 6 months of completion of curative therapy.
This is a partial list of eligibility 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.