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History of Changes for Study: NCT02865135
Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer
Latest version (submitted February 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 10, 2016 None (earliest Version on record)
2 November 29, 2016 Study Status and Study Description
3 December 13, 2016 Recruitment Status, Study Status and Contacts/Locations
4 May 19, 2017 Study Status
5 July 26, 2018 Study Status
6 September 14, 2018 Arms and Interventions, Study Status and Study Description
7 March 13, 2019 Study Status
8 October 24, 2019 Study Status
9 March 23, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 July 15, 2021 Study Status
11 September 1, 2021 Sponsor/Collaborators, Study Status and Contacts/Locations
12 February 18, 2022 Study Status
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Study NCT02865135
Submitted Date:  August 10, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 15-578
Brief Title: Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer
Official Title: A Phase Ib/II Trial To Test The Safety And Efficacy Of Vaccination With HPV16-E711-19 Nanomer For The Treatment Of Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer In HLA-A*02 Positive Patients
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2016
Overall Status: Not yet recruiting
Study Start: September 2016
Primary Completion: May 2019 [Anticipated]
Study Completion: May 2023 [Anticipated]
First Submitted: July 14, 2016
First Submitted that
Met QC Criteria:
August 10, 2016
First Posted: August 12, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 10, 2016
Last Update Posted: August 12, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Dana-Farber Cancer Institute
Responsible Party: Principal Investigator
Investigator: Jochen Lorch, MD
Official Title: MD
Affiliation: Dana-Farber Cancer Institute
Collaborators: Stand Up To Cancer
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This research study is studying a vaccine, named DPX-E7, as a possible treatment for Human Papilloma Virus or HPV related head and neck, cervical or anal cancer (positive for HLA-A*02).
Detailed Description:

This is a phase Ib/II clinical trial. DPX-E7 is a therapeutic vaccine, intended to treat HPV-related head and neck, cervical or anal cancer. DPX-E7 is an investigational vaccine and the FDA (the U.S. Food and Drug Administration) has not approved DPX-E7 vaccine as a treatment for any disease.

DPX-E7 is being tested in humans for the first time. DPX-E7 is a kind of immunotherapy that will make the immune system to elicit an anti-tumor response by generating CD8+ T-cells. CD8+ T-cells play a very important role in fighting against viral infections

Cyclophosphamide is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cell growth.

Open or close this module Conditions
Conditions: Cancer of Head and Neck
Cancer of Cervix
Cancer of Anus
Keywords: HPV Related Head and Neck
Cervical
Anal Cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 44 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: DPX-E7 Vaccine With Cyclophosphamide

Subjects will 2 priming doses of DPX-E7 at a pre-determine dosage 3 weeks apart followed by a predetermine booster dose every 8 weeks until clinical progression.

Low dose metronomic oral Cyclophosphamide will start 7 days before vaccination, continue for 7 days on and then 7 days off, throughout the treatment period, until progression.

Drug: DPX-E7 vaccine
Therapeutic vaccine for the treatment of incurable HPV16-related oropharyngeal, cervical and anal cancer in HLA-A*02 positive patients.
Other Names:
  • HPV vaccine
Drug: Cyclophosphamide
Cyclophosphamide is an alkylating drug indicated for treatment of multiple malignant diseases. In this study a low dose is being given in combination with the DPX-E7 vaccine.
Other Names:
  • Cytoxan
  • Neosar
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Participants Experiencing Adverse Events Related to Treatment
[ Time Frame: 2 years ]

Secondary Outcome Measures:
1. Overall Response Rate
[ Time Frame: 2 years ]

2. Overall Survival Rate
[ Time Frame: 2 years ]

3. Progression Free Survival Rate
[ Time Frame: 2 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Each patient must be positive for HLA-A*02 and meet all of the following inclusion criteria to be enrolled in the study:
  • Histologically or cytologically proven HPVOC or cervical cancer or anal cancer, based on expression of HPV type16 in immunohistochemistry and/or HPV 16 DNA analysis by ISH of tumor tissue from the primary or metastatic lesions.
  • Incurable HPVOC, as defined by:
    • Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. Surgery, radiotherapy or chemoradiotherapy) with no potentially curative option (i.e. surgery or radiation); OR
    • Distant metastasis
  • Incurable cervical or anal cancer, as defined by:
    • Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. systemic chemotherapy) with no potentially curative option (i.e. surgery or chemoradiotherapy). Chemotherapy administered in conjunction with primary radiation as a radiosensitizer will not be counted as a systemic chemotherapy regimen; OR
    • Distant metastasis refractory to initial treatment (at least one prior chemotherapeutic regimen which can include a single chemotherapeutic, a combination of chemotherapeutics, or biologic drugs such as bevacizumab).
  • Accessible tumors for sequential biopsies Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.03) to grade 1 or better (except for < grade 2 neuropathy, alopecia, xerostomia, dysphagia, or mucositis);
  • Age ≥ 18 years;
  • Measurable disease, according to modified RECIST 1.1 and irRECIST (Appendix B & C);
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2 (Appendix A)
  • Adequate bone marrow, liver and renal function, defined by:
    • Hemoglobin ≥ 10 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1000/μL;
    • Absolute lymphocyte count ≥ 400/μL;
    • Platelet count ≥ 100,000/μL;
    • ALT and AST ≤ 2.5 X upper limit of normal (ULN);
    • Total bilirubin ≤ 1.5 X ULN; and
    • Serum creatinine ≤ 1.5 X ULN;
  • Women of child-bearing potential (WOCBP) must be willing to use acceptable means of birth control;
  • Men who could potentially father a child must also use birth control
  • Signed informed consent

Exclusion Criteria:

  • Radiotherapy for primary HPVOC within 8 weeks, or radiotherapy for any other reason within 3 weeks prior to the first dose of trial treatment;
  • Chemotherapy within 3 weeks prior to the first dose of trial treatment;Other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer;
  • Inaccessible tumor or lack of consent for sequential biopsies
  • Uncontrolled central nervous system (CNS) metastases (i.e. known CNS lesions that are radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids);
  • Active hepatitis, known HIV, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids;
  • Autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy;
  • Active uncontrolled serious infection;
  • WOCBP who have a positive β-hCG test or are breastfeeding.
  • Acute or chronic skin disorders that would interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions;
  • Allergies to any vaccine, that after discussion with Immunovaccine, are serious enough to warrant exclusion from this study
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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