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Cisplatin-based Chemotherapy Combined With P16_37-63 Peptide Vaccination in Patients With HPV-positive Cancers

NCT02526316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-07-02

No results posted yet for this study

Summary

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

  • HPV-induced Cancers

Interventions

BIOLOGICAL

P16_37-63 peptide combined with Montanide® ISA-51 VG

Patients will receive P16\_37-63 peptide (100 µg) combined with Montanide® ISA-51 VG vaccination subcutaneously once a week for four weeks, followed by a 4 week rest period

BIOLOGICAL

P16_37-63 peptide without Montanide® ISA-51 VG

Patients will receive 30 mcg P16\_37-63 peptide injected intradermally for test on delayed-type hypersensitivity (DTH) reactions.

Sponsors & Collaborators

  • Oryx GmbH & Co. KG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526316 on ClinicalTrials.gov