Clinical Trials /

Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer

NCT02865135

Description:

This research study is studying a therapeutic 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).

Related Conditions:
  • Anal Carcinoma
  • Cervical Carcinoma
  • Oropharyngeal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 15-578
  • NCT ID: NCT02865135

Conditions

  • Cancer of Head and Neck
  • Cancer of Cervix
  • Cancer of Anus

Interventions

DrugSynonymsArms
DPX-E7 vaccineHPV vaccineDPX-E7 Vaccine

Purpose

This research study is studying a therapeutic 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
    

Trial Arms

NameTypeDescriptionInterventions
DPX-E7 VaccineExperimentalSubjects 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.
  • DPX-E7 vaccine

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants Experiencing Adverse Events Related to Treatment
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Response Rate
Time Frame:2 years
Safety Issue:
Description:
Measure:Overall Survival Rate
Time Frame:2 years
Safety Issue:
Description:
Measure:Progression Free Survival Rate
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Dana-Farber Cancer Institute

Trial Keywords

  • HPV Related Head and Neck
  • Cervical
  • Anal Cancer

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