HPV Anti-CD40 RNA Vaccine (HARE-40)
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|ClinicalTrials.gov Identifier: NCT03418480|
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : May 9, 2018
HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will perform intrapatient dose escalation in patients with previously treated HPV16+ Head & Neck Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV vaccine.
Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer (head and neck, anogenital, penile or cervical) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Squamous Cell Head and Neck Neoplasm Cervical Neoplasm Penile Neoplasms Malignant||Drug: HPV vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic HPV Vaccine Trial +/- Anti-CD40 in HPV-driven Squamous Cell Carcinoma|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: RNA Vaccine A
Arm 1A: 15 (6+9) patients with previously treated HPV16+ head and neck squamous cell carcinoma receiving increasing doses of HPV vaccine.
Drug: HPV vaccine
Experimental: RAN Vaccine B
Arm 1B: 29 (15+14) patients with HPV16+ advanced disease receiving increasing doses of HPV vaccine.
Drug: HPV vaccine
- Dose Limiting Toxicity (DLT) according to CTCAE version 4.03 (Arm 1A) [ Time Frame: 3 months ]Safe and tolerable dose of clinically disease free patients (Arm 1A) - Determination of a suitable dose of HPV RNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418480
|Contact: Kerry-Ann Lee||023 8120 firstname.lastname@example.org|
|Univeristy Hospitals Southampton NHS Foundation Trust||Recruiting|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Contact: Phase I Research Nurses 023 8120 5113 email@example.com|
|Principal Investigator: Christian Ottensmeier, Prof|
|Principal Investigator:||Christian Ottensmeier, Prof||University Hospitals Southampton NHS Foundation Trust|