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

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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

Brief Summary

      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
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants Experiencing Adverse Events Related to Treatment

Secondary Outcome

 Overall Response Rate

Condition

Cancer of Head and Neck

Intervention

DPX-E7 vaccine

Study Arms / Comparison Groups

 DPX-E7 Vaccine
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

11

Start Date

December 2016

Completion Date

May 2023

Primary Completion Date

December 2021

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kartik Seghal, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02865135

Organization ID

15-578


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Stand Up To Cancer

Study Sponsor

Kartik Seghal, MD, Principal Investigator, Dana-Farber Cancer Institute, Boston, MA02215


Verification Date

September 2021