NL-OMON41192
Recruiting
Not Applicable
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 - Phase I Study: Hespecta vaccination in HPV+ head and neck cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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;
Outcomes
Primary Outcomes
Not specified
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