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HPV-induced CancersPhase 1/2NCT01462838

Immune Therapy of HPV-induced Cancers

A Phase 1/2 study testing P16_37-63 in people with HPV-induced Cancers, run by Oryx GmbH & Co. KG at 1 site in Germany.

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

Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16_37-63 in combination with Montanide® ISA-51 VG so that an immune response directed against the tumor cells can be induced. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HPV-induced Cancers
What is being tested?
P16_37-63
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteGermany
Study dates
Aug 2011to May 2015
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

  • Histologically confirmed, advanced HPV-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer cancers under progression, regression or with stable disease after standard therapy (and still incurable) or after refusal of standard therapy or with contraindications for standard treatment
  • HPV positivity as tested by HPV genotyping from paraffin embedded tumor tissue
  • Diffuse expression of p16INK4a in the tumor as analyzed by immunohistochemistry on paraffin embedded tumor tissue.
  • Expected survival of at least six months.
  • Full recovery from surgery, chemo therapy or radiation therapy.
  • ECOG performance status 0, 1 or 2.
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  • The following laboratory results:
  • Neutrophil count ≥ 1.5 x 109/L Lymphocyte count ≥ 0.5 x 109/L Platelet count ≥ 100 x 109/L Serum bilirubin < 2mg/dL
  • Male or female patients ≥ 18 years old
  • Patient´s written informed consent for participation in the trial

Who cannot join

  • Prior treatment with P16_37-63 peptide
  • Clinically significant heart disease (NYHA Class III or IV).
  • Other serious illnesses, eg, serious infections requiring antibiotics or bleeding disorders.
  • History of immunodeficiency disease or autoimmune disease.
  • Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
  • HBV, HCV or HIV positivity.
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  • Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
  • Concomitant treatment with steroids, antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless used in low doses for prevention of an acute cardiovascular event or for pain control). Topical or inhalational steroids are permitted.
  • Participation in any other clinical trial involving another investigational agent within 4 weeks.
  • Pregnancy or lactation.
  • Women of childbearing potential who are not using a medically acceptable means of contraception.
  • Psychiatric or addictive disorders that may compromise the ability to give informed consent.
  • Lack of availability of a patient for immunological and clinical follow-up assessment.
  • Brain metastases (symptomatic and non-symptomatic)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

Other trials in Germany

About this study

Official title: Phase I/IIa Study of Immunization With a p16INK4a Peptide Combined With MONTANIDE ISA-51 VG in Patients With Advanced HPV-associated Cancers

Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16_37-63 in combination with Montanide® ISA-51 VG so that an immune response directed against the tumor cells can be induced. The aim is to show that vaccination with P16_37-63 is safe and can induce or enhance immune responses against p16INK4a.

Read the detailed description

The present study is initiated to evaluate vaccination with P16_37-63 -peptide in patients with advanced HPV- and p16INK4a -positive cervical, vulvar, vaginal, penile, anal or head and neck cancer. Specifically, the present study aims at the following questions:

  • Evaluation of potential toxicity of the vaccination with P16_37-63 -peptide
  • Evaluation of the immune response in patients with advanced HPV- and p16INK4a-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer before vaccination and after vaccination with P16_37-63.

In this context, the present study shall demonstrate whether application of P16_37-63 in a vaccination approach is associated with the induction of peptide-related toxicity. Hence, the study marks the first step towards the application of P16_37-63 in humans, as it provides information on the safety of P16_37-63 as vaccination agent for the first time. Moreover, the study shall provide initial information, whether vaccination with P16_37-63 can induce p16INK4a -specific immune responses in patients with advanced HPV- and p16INK4a -positive cervical, vulvar, vaginal, penile, anal or head and neck cancer. Thus, it shall provide information, whether P16_37-63 has the potential to elicit peptide-specific immune responses and therefore represent a suitable target for the induction of tumor antigen-specific immune responses in this population.

The present study marks an important milestone towards a potential application of P16_37-63 as therapeutic agent in the management of patients with advanced HPV- and p16INK4a -positive cervical, vulvar, vaginal, penile, anal or head and neck cancer. Long-term goal of this approach is to develop novel tools for the palliative and/or adjuvant therapy of patients with advanced advanced HPV- and p16INK4a -positive tumors.

Being tested
P16_37-63
Keywords
advanced HPV-, p16INK4a-positive, cervical, vulvar,, vaginal, penile, anal, head, neck

What participants receive

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

  • P16_37-63Biological

    100 ug per application subcutaneously, mixed with 0.3 ml Montanide ISA-51 VG; once a week for four weeks, followed by a 4 week rest period (1 cycle), up to 3 cycles

Study groups in NCT01462838
Study groupRoleWhat they receive
ImmunizationExperimentalP16_37-63 peptide plus Montanide ISA-51 VG
Receives: Biological: P16_37-63

What is being measured

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

  1. Immune response

    Immune response against peptide P16_37-63. A positive immune response is defined as positive DTH response against peptide P16_37-63 or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) and/or CD8 and/or CD4 cellular (IFN gamma ELISpot for the detection of p16INK4a-specific T cells) immune response exceeding the assay specific cut-off values for a positive response against peptide P16_37-63.

    Measured: every 2 weeks

Secondary outcomes (2)

  1. Tumor response

    assessed by CT or MRI scans according to RECIST

    Measured: every 8 weeks

  2. safety

    number and severity of adverse events categorized according to CTC criteria version 4.0

    Measured: up to 8 months

Timeline

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

  1. First posted31 Oct 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJan 2015
  4. Study completionMay 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01462838
Sponsor's protocol ID
VicOryx
Status last verified
Jun 2015
First submitted
25 Oct 2011
Last updated
23 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing P16_37-63 in people with HPV-induced Cancers, run by Oryx GmbH & Co. KG at 1 site in Germany.

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 10 inclusion and 14 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 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Immune response (time frame: every 2 weeks). 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 NCT01462838.

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 23 Jun 2015.

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