Recurrent Human Papillomavirus Type 16 Associated CancerPhase 1NCT05132803
TA-CIN Vaccine With Anti-PD-1 Therapy in Recurrent HPV16-associated Cancers
A Phase 1 study testing HPV 16 TA-CIN in people with Recurrent Human Papillomavirus Type 16 Associated Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
The primary to assess the safety and tolerability of TA-CIN and anti-PD-1 therapy in patients with recurrent HPV16-associated cancers and to assess the feasibility of IT injection of TA-CIN in patients with recurrent HPV16-associated cancers undergoing treatment with anti-PD-1 therapy. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Human Papillomavirus Type 16 Associated Cancer
- What is being tested?
- HPV 16 TA-CIN
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2021to 18 Jan 2022
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis with one of the following:
- Unresectable recurrent and/or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) 1] as determined by an FDA-approved test.
- Unresectable recurrent and/or metastatic head and neck squamous cell cancer (HNSCC) in either of the following settings:
- i.) The tumor expresses PD-L1 [Combined Positive Score (CPS) 1] as determined by an FDA-approved test and the patient has received no prior therapy, or ii.)The patient has experienced disease progression on or after platinum-containing chemotherapy.
- c)Metastatic anal cancer that has progressed after prior chemotherapy.
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- Eligible for and planning to start therapy with anti-PD-1 therapy based on NCCN guidelines, such as pembrolizumab, every 3 weeks according to standard of care.
- Documented to have HPV16 nucleic acid within the tumor specimen as determined by in situ hybridization. NOTE: HPV16 nucleic acid testing may be done as part of a "pre-screening" consent at any time prior to enrollment on the primary study. Archival tissue will be used to perform this test. To be eligible for HPV16 testing on study, patients must have cancer not amenable to curative therapy and be a candidate for anti-PD-1/PD-L1 antibody therapy.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) Appendix D, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
- A minimum of one injectable lesion at least 1 cm in size as determined by the investigator (for superficial tumors) or radiologist (deep tumors). Lesions in previously irradiated areas may be considered target lesions if progression has been demonstrated.
- Must have adequate organ and marrow function as defined below:
- Screening Organ and Marrow Function Criteria
- absolute neutrophil count ≥1,000/mcL
- absolute lymphocyte count ≥500/mcL
- platelets ≥100,000/mcL
- total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
- AST(SGOT) ≤1.5 × institutional ULN
- ALT(SGPT) ≤1.5 × institutional ULN
- INR ≤1.8 if not on Coumadin, or if on Coumadin, within therapeutic target range and able to discontinue temporarily for study procedures
- creatinine OR glomerular filtration rate (GFR) ≤1.5 × institutional ULN
- 60 mL/min/1.73 m2 per Modified Cockcroft-Gault Formula
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to understand and the willingness to sign a written informed consent document
- For patients with childbearing capacity, agreement (by patient) to use highly effective forms of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly) and to continue its use at least 90 days post last dose of anti-PD-1/PD-L1 antibody therapy.
- Subject is able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as systemic steroids, or with a medical condition that requires systemic immunosuppression.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies
- Previous severe allergic reaction or hypersensitivity to a vaccine or to anti-PD-1 therapy or any of its components.
- Requires anticoagulation that cannot be interrupted for biopsy and intratumoral injection.
- Patient with an uncontrolled intercurrent illness.
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- Patient who has required a blood transfusion in the past 2 weeks.
- Patient with active or chronic infection of HIV, HCV, or HBV.
- The patient has received chemotherapy within 4 weeks prior to study drug administration.
- Patients with a history of prior treatment with anti-PD-1/anti-PD-L1 agents.
- The patient has received radiation to the planned injection site within 4 weeks prior to study drug administration.
- The patient has received other investigational agents within 4 weeks prior to study drug administration.
- Patients who have had surgery within 4 weeks prior to study drug administration, excluding minor procedures (dental work, skin biopsy, etc.).
- Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases within 4 weeks of study treatment. Examples include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid vaccine.
- Note: Seasonal influenza vaccines for injection are generally killed virus vaccine and are allowed. However, intranasal influenza vaccines (e.g. Flu-Mist) are live-attenuated vaccines and are not allowed within 4 weeks of study treatment.
- Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of this therapy. Because there is an unknown but potential risk for adverse events in nursing infants, breastfeeding should be discontinued if the mother is treated on study.
- A history of current or recent invasive malignancy, unless disease free for a minimum of 3 years. Exceptions include basal cell or squamous cell carcinomas of the skin that have received potentially curative therapy.
- The patient has known active central nervous system disease (CNS). For patients with treated brain metastases, they are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Inability to understand or unwillingness to sign an informed consent document
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Women & Infants Center, University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: A Feasibility Trial to Assess Intratumoral Injection of TA-CIN With Anti-PD-1 Therapy for Recurrent HPV16-associated Cancers
The primary to assess the safety and tolerability of TA-CIN and anti-PD-1 therapy in patients with recurrent HPV16-associated cancers and to assess the feasibility of IT injection of TA-CIN in patients with recurrent HPV16-associated cancers undergoing treatment with anti-PD-1 therapy.
- Being tested
- HPV 16 TA-CIN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV 16 TA-CINDrug
No dose escalation or reduction
| Study group | Role | What they receive |
|---|---|---|
| Main Vaccination Arm | Experimental | Participants will receive the HPV 16 TA-CIN vaccine. Receives: Drug: HPV 16 TA-CIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who successfully receive at least one intratumoral vaccination
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study startAug 2021 (estimated)
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Why it stopped: The study team decided not to move forward with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Human Papillomavirus Type 16 Associated CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Gaillard, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132803
- Sponsor's protocol ID
- IRB00290379
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2021
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial to Assess Intratumoral Injection of TA-CIN With Anti-PD-1 Therapy for Recurrent HPV16-associated Cancers
- ClinicalTrials.gov ID
- NCT05132803
- Acronym / sponsor ID
- IRB00290379
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team decided not to move forward with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- 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 primary to assess the safety and tolerability of TA-CIN and anti-PD-1 therapy in patients with recurrent HPV16-associated cancers and to assess the feasibility of IT injection of TA-CIN in patients with recurrent HPV16-associated cancers undergoing treatment with anti-PD-1 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Vaccination Arm | Experimental | Drug: HPV 16 TA-CINParticipants will receive the HPV 16 TA-CIN vaccine. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Age ≥ 18 years
- Diagnosis with one of the following:
- i.) The tumor expresses PD-L1 [Combined Positive Score (CPS) 1] as determined by an FDA-approved test and the patient has received no prior therapy, or ii.)The patient has experienced disease progression on or after platinum-containing chemotherapy.
- c)Metastatic anal cancer that has progressed after prior chemotherapy.
- Eligible for and planning to start therapy with anti-PD-1 therapy based on NCCN guidelines, such as pembrolizumab, every 3 weeks according to standard of care.
Key exclusion criteria (20 listed)
- Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as systemic steroids, or with a medical condition that requires systemic immunosuppression.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies
- Previous severe allergic reaction or hypersensitivity to a vaccine or to anti-PD-1 therapy or any of its components.
- Requires anticoagulation that cannot be interrupted for biopsy and intratumoral injection.
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 |
|---|---|---|
| HPV 16 TA-CINNo dose escalation or reduction | Drug | Main Vaccination Arm |
Primary outcome
Number of patients who successfully receive at least one intratumoral vaccination
Time frame: 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
Related trials for Recurrent Human Papillomavirus Type 16 Associated Cancer
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A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects With HPV Positive HNSCC.
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Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation
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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.
Stéphanie Gaillard, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HPV 16 TA-CIN in people with Recurrent Human Papillomavirus Type 16 Associated Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
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 25 inclusion and 20 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: withdrawn, as of the sponsor's last update on 1 Dec 2022. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients who successfully receive at least one intratumoral vaccination (time frame: 10 weeks). 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 1 Dec 2022.