Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02865135
Recruitment Status : Active, not recruiting
First Posted : August 12, 2016
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
Stand Up To Cancer
Information provided by (Responsible Party):
Kartik Sehgal, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE August 12, 2016
Last Update Posted Date September 9, 2021
Actual Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
Number of Participants Experiencing Adverse Events Related to Treatment [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • Overall Response Rate [ Time Frame: 2 years ]
  • Overall Survival Rate [ Time Frame: 2 years ]
  • Progression Free Survival Rate [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer of Head and Neck
  • Cancer of Cervix
  • Cancer of Anus
Intervention  ICMJE 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 Name: HPV vaccine
Study Arms  ICMJE Experimental: DPX-E7 Vaccine
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.
Intervention: Drug: DPX-E7 vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 23, 2020)
11
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
44
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02865135
Other Study ID Numbers  ICMJE 15-578
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kartik Sehgal, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Stand Up To Cancer
Investigators  ICMJE
Principal Investigator: Kartik Seghal, MD Dana-Farber Cancer Institute, Boston, MA02215
PRS Account Dana-Farber Cancer Institute
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP