Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBlueSky Immunotherapies GmbH
About this trial
A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
T2N2-3, M0
T3N0-3, M0
T4N0-3, M0
Primary tumour accessible for biopsy and intratumoural administration
Disqualifiers
Distant metastases
Secondary, not HPV16-associated, malignancy
History of malignancy other than the target malignancy to be investigated in this trial unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease
Trial design
Design model
Single group
Treatments tested in this trial
FluBHPVE6E7
Biological/VaccineIntratumoral administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency and severity of adverse events (AEs)
To assess the severity of the adverse event is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame
7 daysSecondary outcomes
1
Intralesional T-cell infiltration
To assess the intralesional T-cell infiltration in tumour tissue available from surgery or biopsy by immunohistological staining.
Time frame
24 weeks2
Biodistribution
To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in nasal secretion samples by RT-qPCR (copies per ml blood).
Time frame
24 weeks3
Virus recovery in oropharyngeal secretion samples
To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in oropharyngeal secretion samples by RT-qPCR (copies per sample).
Time frame
7 days4
Virus recovery in saliva
To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in saliva samples by RT-qPCR (copies per sample).
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov