oropharyngeal squamous cell cancer
Conditions
Interventions
Patients first treated with curative intent for advanced HPV16+ OSCC will be
vaccinated intradermally (i.d.) in four dose escalation groups (1, 5, 20 or 50
µg/peptide). Each dose group exists of 6 p
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must meet all the following criteria in order to be included in the study: 1. Histologically documented evidence of HPV16 positive stage III or IV OSCC treated with curative intent 2. No evidence of residual OSCC based on physical examination at the completion of curative intent therapy 3. At least four weeks and less than twelve weeks after last anti-tumor treatment 4. Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines 5. Patients must be 18 years or older. 6. Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study (up to 2 months after the last vaccination) 7. Patients must be in good general health and ambulatory, with an ECOG performance status of 0 or 1
Exclusion criteria
Exclusion criteria: Patients who meet the following exclusion criteria will not be eligible for admission to the study: 1. Radiotherapy, chemotherapy or other potentially immunosuppressive therapy administered within 4 weeks prior to the enrolment visit 2. History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or patients receiving immunosuppressive therapy, except for topical application 3. History of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from OSCC 4. Receipt of another investigational product within the previous 4 weeks or at any time during the study period. 5. Receipt of prior HPV directed immunotherapy 6. Hematology and biochemistry: • Absolute Neutrophil Count (ANC) < 1.5 x 109/L, or platelet count < 100 x 109/L or hemoglobin < 6 mmol/L. • Serum (total) bilirubin > 2 x upper normal limit (ULN); • Aspartate Aminotransferase (ASAT) or Alanine Aminotransferase (ALAT) > 2.5 x ULN; • Alkaline phosphatase levels > 2.5 x ULN; • Serum creatinine within normal limits or calculated clearance >= 50 mL/min/1.73 m2 for patients with serum creatinine levels above the institutional normal value 7. Active HIV, chronic hepatitis B or C infection. 8. Any condition that in the opinion of the investigator could interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to determine the biological activity of Hespecta that is able to induce HPV16 E6-specific T-cell mediated immunity within a proposed dose escalation of 1, 5, 20 or 50 µg/peptide-conjugate in patients treated for HPV16+ OSCC. Blood samples will be drawn and used in an array of complementary immunological assays (HPV16-specific proliferation assay, IFNγ-ELISPOT, cytokine bead array and multiparameter flow cytometry analysis) to assess the biological activity of Hespecta. These established assays are performed at 4 different time points (baseline and 3 time points after start of vaccination). Vaccine-induced immunity in the different assays is defined as a post-vaccination response that is at least 3 times higher than the pre-vaccination response. Biological activity is identified if it is seen in at least 2 assays at 2 consecutive follow-up time points after the baseline assessment, in line with CVCTWG criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: to study safety of Hespecta by collecting all adverse events according to CTCAE v4.0 | — |
Countries
Netherlands
Outcome results
None listed