advanced HPV- and p16INK4a-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer MedDRA version: 14.1 Level: HLT Classification code 10008230 Term: Cervix neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: HLT Classification code 10002125 Term: Anal canal neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA
Conditions
Interventions
Product Name: P16_37-63
Pharmaceutical Form: Powder for solution for injection
Sponsors
Oryx GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically confirmed, advanced HPV-positive cancers of entities and stages as defined in the following listing under progression, regression or with stable disease (and still incurable) after standard therapy or after refusal of standard therapy as defined in the following listing or with contraindications for standard treatment •HPV positivity •Diffuse expression of p16INK4a in the tumor •Expected survival of at least six months. •Full recovery from surgery, chemo therapy or radiation therapy. •ECOG performance status 0, 1 or 2. •adequate blood and biochemistry parameters •Male or female* patients = 18 years old •Patient´s written informed consent for participation in the trial l Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Prior treatment with P16_37-63 peptide •Clinically significant heart disease (NYHA Class III or IV). •Other serious illnesses, eg, serious infections requiring antibiotics or bleeding disorders. •History of immunodeficiency disease or autoimmune disease. •Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available. •HBV, HCV or HIV positivity. •Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry •Concomitant treatment with steroids, antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless used in low doses for prevention of an acute cardiovascular event or for pain control). Topical or inhalational steroids are permitted. •Participation in any other clinical trial involving another investigational agent within 4 weeks. •Pregnancy or lactation. •Women of childbearing potential who are not using a medically acceptable means of contraception. •Psychiatric or addictive disorders that may compromise the ability to give informed consent. •Lack of availability of a patient for immunological and clinical follow-up assessment. •Brain metastases (symptomatic and non-symptomatic)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I Part: Safety of the vaccine Phase IIa Part: Immune response against the p16_37-63 peptide;Secondary Objective: Phase I Part: Immune response against the p16_37-63 peptide Tumor response Phase IIa Part: Safety of the vaccine Tumor response ;Primary end point(s): Phase IIa: Immune response against peptide P16_37-63. A positive immune response is defined as positive DTH response against peptide P16_37-63 or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) and/or CD8 and/or CD4 cellular (IFN gamma ELISpot for the detection of p16INK4a-specific T cells) immune response exceeding the assay specific cut-off values for a positive response against peptide P16_37-63.;Timepoint(s) of evaluation of this end point: humoral immune response at weeks 1, 3, 9, 11, 17, 19, 25 cellular immune response and DTH: weeks 1, 9, 17, 25. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety of the vaccine Tumor response ;Timepoint(s) of evaluation of this end point: safety: at every visit tumor response: every 8 weeks | — |
Countries
Germany
Contacts
Public ContactInstitut für Klinische Forschung
Krankenhaus Nordwest
Outcome results
None listed