study of sqz-pbmc-hpv in patients with hpv16+ recurrent, locally advanced or metastatic solid tumors

Conditions: Adult Solid Tumor

Summary: this is a phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of sqz-pbmc-hpv as monotherapy and in combination with atezolizumab or other immune checkpoint inhibitors in hla-a\*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (hpv16+) solid tumors. the study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.


Eligibility criteria:
key inclusion criteria: * male or female patients ≥18 years of age who are hla-a\*02+ (performed during screening locally or centrally, or based on documented historic test results) * histologically confirmed incurable or metastatic solid tumors that are hpv16+ (performed during screening locally or centrally, or based on documented historic test results) * cancer must have progressed after at least 1 available standard therapy for incurable disease, or the patient is intolerant to or refuses standard therapy(ies) or has a tumor for which no standard therapy(ies) exist * eastern cooperative oncology group (ecog) performance status (ps) of 0 to 1 * at least 1 measurable lesion according to recist 1.1 * must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at baseline and on cycle 2 day 8 (+/- 3 days) * patients must agree to venous access for the leukapheresis and be willing to have a central line inserted if venous access is an issue * adequate organ function and bone marrow reserve performed within 14 days prior to the leukapheresis exclusion criteria: * treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis. for prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to leukapheresis * systemic treatment with either corticosteroids (\>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to leukapheresis * patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months may not be eligible and should be discussed with the sponsor * patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the sponsor * patients with \>grade 1 aes related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement * known active hepatitis b or hepatitis c, or active mycobacterium tuberculosis infection * history of any grade 3 immune-related ae (irae) from prior immunotherapy * has known active central nervous system metastases * history of interstitial lung disease requiring steroids * major surgery within 2 weeks of leukapheresis

Keywords: recurrent cancer metastatic locally advanced cancer cervical head and neck anal penile sqz-pbmc-hpv atezolizumab hpv16 apc cell therapy ipilimumab nivolumab checkpoint inhibitors immunotherapy solid tumor hla-a*02 therapeutic vaccine advanced solid tumor rectal vulvar vaginal pbmc human papillomavirus strain 16 peripheral blood mononuclear cells antigen presenting cells