A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial

This is an interventional treatment trial for Locally Advanced Cervical Squamous Cell Carcinoma, Not Otherwise Specified Read More

Inclusion Criteria:

• Newly diagnosed locally advanced squamous cell carcinoma of cervix (Federation of Gynecology and Obstetrics [FIGO] 2018 stage IB3-IVA with primary tumor >= 5 cm and/or positive pelvic or periaortic nodal disease assessed by imaging)
• Histologic diagnosis of squamous cell carcinoma of the cervix
• Written informed consent before initiation of any study-related procedures
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Alanine aminotransferase (ALT) =< 2-fold the upper limit of normal
• Aspartate aminotransferase (AST) =< 2-fold the upper limit of normal
• Alkaline phosphatase (alk phos) =< 2-fold the upper limit of normal
• Total bilirubin (total bili) =< 2-fold the upper limit of normal
• Creatinine =< 1.5
• Electrocardiogram (ECG) with no clinically significant findings (as assessed by the investigator) performed within 30 days of signing the informed consent form
• Absence of current malignancies at other sites, except for adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 5 years and who are deemed at low risk for recurrence are eligible for the study

Exclusion Criteria:

• Human immunodeficiency virus (HIV) infection, cellular immune deficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies
• Prior diagnosis of hepatitis B or C (unless anti-hepatitis C therapy has produced a sustained virologic response)
• History of clinically significant autoimmune disease, Crohn's disease, or ulcerative colitis
• Serious concomitant disorder, including active systemic infection requiring treatment, as judged by the investigator
• Receipt of immunotherapy (e.g., interferons [IFNs], check-point inhibitors, tumor necrosis factor, interleukins, etc.) or biological response modifiers (granulocyte-macrophage colony-stimulating factor [GM-CSF], granulocyte colony-stimulating factor, macrophage colony-stimulating factor) within 4 weeks before the first study vaccination

• Receipt of chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug

  • Current or recent use of physiologic doses of intra-articular, topical, or inhaled corticosteroids is acceptable
• History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines [e.g., Silgard, Cervarix, Gardasil are not excluded)
• Known or suspected hypersensitivity to any component of the investigational product or contraindications to cisplatin (e.g., peripheral neuropathy grade =< 2 or ototoxicity =< grade 2 per Common Terminology Criteria for Adverse Events [CTCAE] version [v]5.0)
• Previous pelvic radiation therapy (RT)
• Previous chemotherapy for the cervix tumor
• Previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy
• Prior major surgery within 4 weeks of enrollment from which the patient has not recovered
• Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results
• Concurrent participation in another therapeutic investigational study or use of another investigational drug within 6 months before the first study vaccination
• Previous enrollment in this study
• HPV genotyping is to be done from cervical swab samples. Enrollment will not require HPV testing
• Pregnancy: a female subject defined as a women of childbearing potential (WOCBP) who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required