Clinical Trial TitleA phase 2, multi-center, open label study to evaluate efficacy and safety of adenoviral p53 (Ad-p53) in combination with immune checkpoint inhibitor therapy in patients with progression or recurrence of head and neck squamous cell carcinoma (HNSCC).
Clinical Trial Protocol Description:
The purpose of this study is to learn whether doses of an investigational drug called Ad-p53 are safe and effective when injected into your tumors. The investigational Ad-p53 will be combined with an FDA approved immunotherapy called an immune checkpoint inhibitor, either Keytruda or Opdivo. Studies in animal tumor models have shown that Ad-p53 enhances the ability of immune checkpoint inhibitors to kill cancer cells. This study is being conducted to determine whether similar enhanced effects of the combined treatment may occur in cancer patients.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female at leasst 18 years of age. Females of childbearing potential must be non-pregnant, non-lactating. Males and females must agree to use barrier contraception for the duration of the study.
- Have recurrent head and neck squamous cell carcinoma (HNSCC), excluding endolaryngeal recurrence, meeting the following criteria:
- Each patient entered on the study must have disease that that is evaluable for response using RECIST 1.1 criteria with a minimum size of 1 cm by CT/MRI or physical examination.
- No visible or symptomatic brain metastases.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior radiation performed to areas of measurable disease ≤ four weeks of study entry unless there is documented evidence of disease progression.
- Have used systemic anti-cancer therapy ≤ 4 weeks, or six weeks if the systemic therapy contains a nitrosourea or mitomycin C.
- Have had prior additional malignancy within 2 years except for non-melanoma skin cancer, carcinoma in situ of the breast, oral cavity or cervix.
- Have been treated in clinical studies of non-approved experimental agents ≤ four weeks of study entry.
- Have had prior autologous or allogenic organ or tissue transplantation.
This is a partial list of inclusion and exclusion criteria.