HPV-induced CancersPhase 1VICORYX-2NCT02526316
Cisplatin-based Chemotherapy Combined With P16_37-63 Peptide Vaccination in Patients With HPV-positive Cancers
A Phase 1 study testing P16_37-63 peptide combined with Montanide® ISA-51 VG and P16_37-63 peptide without Montanide® ISA-51 VG in people with HPV-induced Cancers, run by Oryx GmbH & Co. KG at 1 site in Germany.
Trial summary
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). 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 peptide combined with Montanide® ISA-51 VG and P16_37-63 peptide without Montanide® ISA-51 VG
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to May 2017
- Phase
- Phase 1
- 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 cancer
- HPV positivity as tested by HPV genotyping from paraffin embedded tumor tissue using Linear Array HPV Genotyping test from Roche Diagnostics Germany GmbH
- Diffuse expression of p16INK4a in the tumor as analyzed by immunohistochemistry on paraffin embedded tumor tissue using the CINtec p16INK4a histology kit
- Planned cisplatin-based chemotherapy with an expected duration of at least 2 months. A carboplatin-based therapy may be selected as an alternative by investigators choice
- Expected survival of at least 3 months
- Full recovery from prior surgery, chemotherapy or radiation therapy (except for alopecia, fatigue or neurotoxicity of grade 1 or 2
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- ECOG performance status 0, 1 or 2
- 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
- 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, e.g., 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
- Known HBV, HCV or HIV positivity
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- 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. Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
- 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.
About this study
Official title: 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
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.
Read the detailed description
10 patients with HPV- and p16INK4a-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer will be enrolled. The p16INK4a-peptide (p16INK4a-37-63, 100 mcg) mixed with MONTANIDE ISA-51 VG (0.3 ml) will be administered subcutaneously once weekly for four weeks, followed by a 4-week rest period (1 cycle). This schedule will be repeated for a total of 3 cycles (= 6 months) or until tumor progression or intolerable toxicity is documented. The first application will be done one week before chemotherapy initiation or continuation. Concurrent radiation is allowed and should be documented. If chemotherapy is withhold for toxicity, vaccination treatment can be continued.
Patients will be seen at baseline/screening and at every visit for safety assessment until disease progression or discontinuation of trial therapy for other reasons. Immunological assessments will be made in all patients. The immunological assessment includes the delayed time hypersensitivity response (DTH) against the P16_37-63 peptide. Therefore in week 1, 9, 17 and 25, 30 mcg P16_37-63 peptide solution without MONTANIDE ISA-51 VG will be injected at a separate site from the vaccination site intradermally. Immunological responses are evaluated at baseline and after vaccination in weeks 9, 17 and 25 (ELISPOT) and in weeks 1, 3, 9, 11, 17, 19 and 25 (ELISA) and are compared to the antigen-specific immune response measured before vaccination (week 1). Radiological tumor assessment (CT, MRI) will be performed at baseline and then every 8 weeks (after every cycle). There will be a follow- up visit four weeks after the last vaccination for safety. Further follow-up regarding progression and death can be performed, e.g. via a phone call. Autoimmunity will be assessed every 8 weeks. Safety of the immunization will be analyzed as assessed by the number and severity of adverse events categorized according to CTC criteria
- Conditions
- HPV-induced Cancers
- Being tested
- P16_37-63 peptide combined with Montanide® ISA-51 VG, P16_37-63 peptide without Montanide® ISA-51 VG
- Keywords
- cervical cancer, vulvar cancer, vaginal cancer, penile cancer, anal cancer, head and neck cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Penile Neoplasms, Anus Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P16_37-63 peptide combined with Montanide® ISA-51 VGBiological
Patients will receive P16_37-63 peptide (100 µg) combined with Montanide® ISA-51 VG vaccination subcutaneously once a week for four weeks, followed by a 4 week rest period
P16_37-63 peptide without Montanide® ISA-51 VGBiological
Patients will receive 30 mcg P16_37-63 peptide injected intradermally for test on delayed-type hypersensitivity (DTH) reactions.
| Study group | Role | What they receive |
|---|---|---|
| P16_37-63 Vaccination | Other | 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. Receives: Biological: P16_37-63 peptide combined with Montanide® ISA-51 VG; Biological: P16_37-63 peptide without Montanide® ISA-51 VG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response against peptide P16_37-63
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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: week 1
Immune response against peptide P16_37-63
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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: week 3
Immune response against peptide P16_37-63
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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: week 9
Immune response against peptide P16_37-63
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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: week 11
Immune response against peptide P16_37-63
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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: week 17
Immune response against peptide P16_37-63
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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: week 19
Immune response against peptide P16_37-63
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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: week 25
Secondary outcomes (4)
Tumor response as assessed by CT or MRI scans according to RECIST
Measured: baseline, after every cycle up to 25 weeks
Case wise listing of progression-free survival
Measured: four weeks after last vaccination
Safety of the vaccine administration as assessed by the number and severity of adverse events categorized according to CTC criteria version 4.0.
Measured: up tp week 25, 4 weeks after last vaccination
Case wise listing of overall survival
Measured: four weeks after last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-induced CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oryx GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526316
- Sponsor's protocol ID
- VICORYX-2
- Acronym
- VICORYX-2
- Status last verified
- Jun 2017
- First submitted
- 10 Aug 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02526316
- Acronym / sponsor ID
- VICORYX-2 / VICORYX-2
- Conditions
- HPV-induced Cancers
- Keywords
- cervical cancer, vulvar cancer, vaginal cancer, penile cancer, anal cancer, head and neck cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Oryx GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
10 patients with HPV- and p16INK4a-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer will be enrolled. The p16INK4a-peptide (p16INK4a-37-63, 100 mcg) mixed with MONTANIDE ISA-51 VG (0.3 ml) will be administered subcutaneously once weekly for four weeks, followed by a 4-week rest period (1 cycle). This schedule will be repeated for a total of 3 cycles (= 6 months) or until tumor progression or intolerable toxicity is documented. The first application will be done one week before chemotherapy initiation or continuation. Concurrent radiation is allowed and should be documented. If chemotherapy is withhold for toxicity, vaccination treatment can be continued.
Patients will be seen at baseline/screening and at every visit for safety assessment until disease progression or discontinuation of trial therapy for other reasons. Immunological assessments will be made in all patients. The immunological assessment includes the delayed time hypersensitivity response (DTH) against the P16_37-63 peptide. Therefore in week 1, 9, 17 and 25, 30 mcg P16_37-63 peptide solution without MONTANIDE ISA-51 VG will be injected at a separate site from the vaccination site intradermally. Immunological responses are evaluated at baseline and after vaccination in weeks 9, 17 and 25 (ELISPOT) and in weeks 1, 3, 9, 11, 17, 19 and 25 (ELISA) and are compared to the antigen-specific immune response measured before vaccination (week 1). Radiological tumor assessment (CT, MRI) will be performed at baseline and then every 8 weeks (after every cycle). There will be a follow- up visit four weeks after the last vaccination for safety. Further follow-up regarding progression and death can be performed, e.g. via a phone call. Autoimmunity will be assessed every 8 weeks. Safety of the immunization will be analyzed as assessed by the number and severity of adverse events categorized according to CTC criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P16_37-63 Vaccination | Other | Biological: P16_37-63 peptide combined with Montanide® ISA-51 VG, Biological: P16_37-63 peptide without Montanide® ISA-51 VGPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed, advanced HPV-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer cancer
- HPV positivity as tested by HPV genotyping from paraffin embedded tumor tissue using Linear Array HPV Genotyping test from Roche Diagnostics Germany GmbH
- Diffuse expression of p16INK4a in the tumor as analyzed by immunohistochemistry on paraffin embedded tumor tissue using the CINtec p16INK4a histology kit
- Planned cisplatin-based chemotherapy with an expected duration of at least 2 months. A carboplatin-based therapy may be selected as an alternative by investigators choice
- Expected survival of at least 3 months
Key exclusion criteria (14 listed)
- Prior treatment with P16_37-63 peptide
- Clinically significant heart disease (NYHA Class III or IV)
- Other serious illnesses, e.g., 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P16_37-63 peptide combined with Montanide® ISA-51 VGPatients will receive P16_37-63 peptide (100 µg) combined with Montanide® ISA-51 VG vaccination subcutaneously once a week for four weeks, followed by a 4 week rest period | Biological | P16_37-63 Vaccination |
| P16_37-63 peptide without Montanide® ISA-51 VGPatients will receive 30 mcg P16_37-63 peptide injected intradermally for test on delayed-type hypersensitivity (DTH) reactions. | Biological | P16_37-63 Vaccination |
Primary outcome
Immune response against peptide P16_37-63
Time frame: week 1
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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
Immune response against peptide P16_37-63
Time frame: week 3
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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
Immune response against peptide P16_37-63
Time frame: week 9
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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
Immune response against peptide P16_37-63
Time frame: week 11
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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
Immune response against peptide P16_37-63
Time frame: week 17
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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
Immune response against peptide P16_37-63
Time frame: week 19
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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
Immune response against peptide P16_37-63
Time frame: week 25
A positive immune response is defined as positive DTH response against peptide P16_37-63 and/or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) 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
4 secondary outcomes
Tumor response as assessed by CT or MRI scans according to RECIST
Time frame: baseline, after every cycle up to 25 weeks
Case wise listing of progression-free survival
Time frame: four weeks after last vaccination
Safety of the vaccine administration as assessed by the number and severity of adverse events categorized according to CTC criteria version 4.0.
Time frame: up tp week 25, 4 weeks after last vaccination
Case wise listing of overall survival
Time frame: four weeks after last vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P16_37-63 peptide combined with Montanide® ISA-51 VG and P16_37-63 peptide without Montanide® ISA-51 VG 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 9 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 2 Jul 2017. 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 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.
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 against peptide P16_37-63 (time frame: week 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.