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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 (VICORYX-2)

NCT02526316 Phase 1 COMPLETED

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.

Details

Lead sponsorOryx GmbH & Co. KG
PhasePhase 1
StatusCOMPLETED
Enrolment11
Start date2015-06
Completion2017-05

Conditions

Interventions

Primary outcomes

Countries

Germany