Phase I study: to determine the biological activity of two HPV16 E6 specific peptides coupled to Amplivant®, a Toll-like receptor ligand in nonmetastatic patients treated for HPV16-positive head and neck cancer

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 24

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

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