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Human Papilloma Virus Related CarcinomaPhase 1/2HARE-40NCT03418480

HARE-40: HPV Anti-CD40 RNA vaccinE

A Phase 1/2 study testing BNT113 in people with Human Papilloma Virus Related Carcinoma and Head and Neck Neoplasm, run by University of Southampton at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BNT113
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited Kingdom
Study dates
11 Apr 2017to 24 Jan 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Arm 1A:
  • Previous HPV16+ head and neck squamous cell carcinoma.
  • At least 12 months after completion of treatment.
  • Within 5 years of treatment completion.
  • Currently no clinical evidence of disease.
  • ECOG performance status 0 or 1.
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  • Patient has adequate venous access in order to obtain all required blood samples and to undergo Leukapheresis as per protocol
  • Arm 1B:
  • HPV16+ head and neck, cervical, anogenital and penile carcinoma patients with recurrent disease.
  • Intention to treat is palliative.
  • Tissue samples available confirming HPV16+ disease to send to Central Laboratory.
  • Patient has adequate venous access in order to obtain all required blood samples and to undergo Leukapheresis as per protocol

Who cannot join

  • Patients unable to consent.
  • Any patient who has been previously vaccinated with BNT113 in any Arm of the trial.
  • <18 years
  • Systemic steroids (prednisolone >10 mg/day or equivalent) or other drugs with a likely effect on immune competence are forbidden during the trial. The predictable need of their use will preclude the patient from trial entry. Replacement steroids for adrenal insufficiency/failure are allowed.
  • Major surgery in the preceding three to four weeks, which the patient has not yet recovered from.
  • Patients who are of high medical risk because of non-malignant systemic disease, as well as those with active uncontrolled infection.
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  • Patients with clinically relevant autoimmune disease will be excluded.
  • Patients who are known to be allergic to any of the excipients or constituents of the vaccine
  • Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial, such as concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease.
  • Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. For Arm 1A; cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the trial. For Arm 1B; cancer survivors, who have undergone potentially curative therapy for a prior malignancy, and have no evidence of that disease for one year, are eligible for the trial.
  • Patients who are serologically positive for or are known to suffer from Hepatitis B, C, Syphilis or HIV. Counselling will be offered to all patients prior to testing.
  • Patients who have a positive pregnancy test or who are breast feeding.
  • Fertile males or females who are unable or unwilling to use an effective method of birth control (eg. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches, intrauterine device, or intrauterine hormone-releasing system) during study treatment and until 28 days after patients finish the study treatment.
  • Elevated Liver Function Tests - ALT >3.0 x ULN, AST >3.0 x ULN, Bilirubin >3.0 x ULN.
  • Arm 1B patients with the presence of liver metastasis only: Elevated Liver Function Tests - ALT >5.0 x ULN, AST >5.0 x ULN, ALP >5.0 x ULN. Patients who are likely to have rapid disease progression may not be good candidates for the trial. In such cases, please discuss with the Chief Investigator.
  • Any other investigational drug within 28 days or 5 half-lives depending on what gives the longer range before the first treatment of this study

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Univeristy Hospitals Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

Official title: Therapeutic HPV Vaccine (BNT113) Trial in HPV16 Driven Carcinoma

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, cervical and other) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.

Read the detailed description

HARE-40 is a phase I/II vaccine dose escalation trial with two arms (Arm 1A and Arm 1B) in which we will test BNT113 as monotherapy. We will undertake a multi-centre phase I, open label trial in patients with previous HPV16+ HNSCC without current clinical evidence of disease (Arm 1A) and in patients with HPV16+ advanced disease (Arm 1B). The HPV16 antigen-specific immune response will be evaluated before and after treatment in circulating blood and, where samples have been collected, in tumour and skin biopsies.

Arms 1A and 1B will escalate BNT113 in each patient (intrapatient dose escalation) up to the specified target dose of the cohort to establish a safe, tolerable and recommended dose of BNT113 in patents who are disease free (Arm 1A) and those with advanced disease (Arm 1B).

Subset of patients in Arm 1B will also be assessed for response to the vaccine in terms of a significant increase of immune cells following BNT113 administration and according to irRECIST1.1 (all 29 patients including the expansion cohort) and other endpoints.

Being tested
BNT113
Medical subject headings
Head and Neck Neoplasms, Uterine Cervical Neoplasms, Penile Neoplasms, Neoplasms, Unknown Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT113Drug

    Intravenous vaccine

Study groups in NCT03418480
Study groupRoleWhat they receive
RNA Vaccine AExperimentalArm 1A: 15 (6+9) patients with previously treated HPV16+ head and neck squamous cell carcinoma receiving increasing doses of HPV vaccine. - COMPLETE no longer recruiting
Receives: Drug: BNT113
RNA Vaccine BExperimentalArm 1B: 29 (15+14) patients with HPV16+ advanced disease receiving increasing doses of HPV vaccine. COMPLETE - No longer recruiting (Note: Cohort 2 of Arm 1B did not proceed)
Receives: Drug: BNT113

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT) according to CTCAE version 4.03 (Arm 1A and Arm 1B)

    Safe and tolerable dose of BNT113 monotherapy in patients with HPV16+ HNSCC (Arm 1A; adjuvant HNSCC setting) and advanced cancer (Arm 1B; advanced HPV16+ disease setting)

    Measured: Adverse Events reported from the time of first vaccine administration up to 28 days after the last administration. Serious Adverse Events suspected to be related to study drug to be reported until the end of follow up.

Secondary outcomes (10)

  1. Safety (Arm 1A and Arm 1B)

    Adverse event rate according to CTCAE v4.03

    Measured: Adverse Events reported from the time of first vaccine administration up to 28 days after the last administration. Serious Adverse Events suspected to be related to study drug or a study procedure to be reported until the end of follow up.

  2. Vaccine immunogenicity (Arm 1A and Arm 1B)

    Defined as induction or increase in T Cell response against E6 and/or E7 and B-cell immune responses at any post-vaccination visit, compared to baseline.

    Measured: From first vaccine administration until end of follow up

  3. Duration of detectable vaccine-induced immune responses (Arm 1A and Arm 1B)

    Duration of detectable vaccine-induced immune responses (if appropriate).

    Measured: From first vaccine administration until end of follow up

  4. Percentage change in densities of immune cells in tumour tissue (Arm 1B)

    Percentage change in densities of immune cells in tumour tissue (where paired tumour samples have been collected).

    Measured: From Baseline to End of Treatment

  5. Intra-tumoural levels of HPV16-specific immune responses (Arm 1B)

    Intra-tumoural levels of HPV16-specific immune responses (where paired tumour samples have been collected)

    Measured: From Baseline to End of Treatment

  6. Clinical response (Arm 1B)

    Clinical response according to irRECIST 1.1 at End of Treatment, and at Follow up 1 (3 months after last vaccination).

    Measured: From Baseline to 3 months after last vaccination

  7. Disease control rate (Arm 1B)

    Disease control rate according to irRECIST 1.1 at Follow up 1 (3 months after last vaccination)

    Measured: From Baseline to 3 months after last vaccination

  8. Best overall response (Arm 1B)

    Best overall response (irRECIST 1.1)

    Measured: From baseline to date of disease progression or death from any cause, whichever comes first, assessed up to 36 months

  9. Progression-Free Survival (Arm 1B)

    Progression-Free Survival (PFS).

    Measured: From baseline to date of disease progression or death from any cause, whichever comes first, assessed up to 36 months

  10. Overall Survival (Arm 1B)

    Overall Survival (OS)

    Measured: From baseline to date of disease progression or death from any cause, whichever comes first, assessed up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2018
  2. Study start11 Apr 2017
  3. Primary completion1 Nov 2023
  4. Study completion24 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03418480
Sponsor's protocol ID
RHMCAN0983
Other IDs
2014-002061-30, ISRCTN51789191, 2014
Acronym
HARE-40
Status last verified
Feb 2024
First submitted
15 Nov 2017
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BNT113 in people with Human Papilloma Virus Related Carcinoma and Head and Neck Neoplasm, run by University of Southampton at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) according to CTCAE version 4.03 (Arm 1A and Arm 1B) (time frame: Adverse Events reported from the time of first vaccine administration up to 28 days after the last administration. Serious Adverse Events suspected to be related to study drug to be reported until the end of follow up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03418480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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