Clinical trial · Interventional
Cisplatin-based Chemotherapy Combined With P16_37-63 Peptide Vaccination in Patients With HPV-positive Cancers
Pilot Study on Concurrent Cisplatin-based Chemotherapy Combined With Vaccination Therapy With the P16_37-63 Peptide in Patients With HPV- and p16INK4a-positive Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will include 10 patients with HPV-associated ano-genital cancer (cervical, vulvar, vaginal, penile, anal) or HPV-associated head and neck cancer, who are planned to receive a cisplatin-based chemotherapy (alternatively a carboplatin-based chemotherapy may be selected by investigators choice). Patients will receive P16\_37-63 peptide (100 µg) combined with Montanide® ISA-51 VG subcutaneously once a week for four weeks, followed by a 4 week rest period (1 cycle). The vaccination is to be started one week before the initiation or continuation of the cisplatin-based chemotherapy. Concurrent radiation is allowed and should be documented. The vaccination schedule will be repeated up to a total of 3 cycles (= 6 months) or until progression or intolerable toxicity. If chemotherapy is withheld (e.g. for toxicity), vaccination treatment can be continued.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV-induced Cancers | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| P16_37-63 peptide combined with Montanide® ISA-51 VG | Biological | — | UNRESOLVED |
| P16_37-63 peptide without Montanide® ISA-51 VG | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- P16_37-63 Vaccination
- description
- Patients will receive P16\_37-63 peptide (100 μg) combined with Montanide® ISA-51 VG subcutaneously once a week for four weeks, followed by a 4 week rest period (1 cycle). The vaccination is to be started one week before the initiation or continuation of the cisplatin-based chemotherapy.
- interventionNames
- Biological: P16_37-63 peptide combined with Montanide® ISA-51 VG
- Biological: P16_37-63 peptide without Montanide® ISA-51 VG
Primary outcomes (7)
- measure
- Immune response against peptide P16_37-63
- timeFrame
- week 1
- description
- A positive immune response is defined as positive DTH response against peptide P16\_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, advanced HPV-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer cancer * HPV positivity as tested by HPV genotyping from paraffin embedded tumor tissue using Linear Array HPV Genotyping test from Roche Diagnostics Germany GmbH * Diffuse expression of p16INK4a in the tumor as analyzed by immunohistochemistry on paraffin embedded tumor tissue using the CINtec p16INK4a histology kit * Planned cisplatin-based chemotherapy with an expected duration of at least 2 months. A carboplatin-based therapy may be selected as an alternative by investigators choice * Expected survival of at least 3 months * Full recovery from prior surgery, chemotherapy or radiation therapy (except for alopecia, fatigue or neurotoxicity of grade 1 or 2 * ECOG performance status 0, 1 or 2 * The following laboratory results: Neutrophil count ≥ 1.5 x 109/L Lymphocyte count ≥ 0.5 x 109/L Platelet count ≥ 100 x 109/L Serum bilirubin \< 2mg/dL * Patient´s written informed consent for participation in the trial Exclusion Criteria: * Prior treatment with P16\_37-63 peptide * Clinically significant heart disease (NYHA Class III or IV) * Other serious illnesses, e.g., 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 * Known HBV, HCV or HIV positivity * 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. Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) * 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)
References
Publications (0)
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