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

• ClinicalTrials.gov Identifier: NCT02865135
• Recruitment Status: Active, not recruiting
• First Posted: August 12, 2016
• Last Update Posted: February 21, 2022
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: Stand Up To Cancer
• Information provided by (Responsible Party): Kartik Sehgal, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: July 14, 2016
• First Posted Date: August 12, 2016
• Last Update Posted Date: February 21, 2022
• Actual Study Start Date: December 2016
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 10, 2016): Number of Participants Experiencing Adverse Events Related to Treatment [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

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

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 23, 2020): 11
• Original Estimated Enrollment (submitted: August 10, 2016): 44
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02865135
• Other Study ID Numbers: 15-578
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kartik Sehgal, Dana-Farber Cancer Institute
• Original Responsible Party: Jochen Lorch, MD, Dana-Farber Cancer Institute, MD
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Stand Up To Cancer

Investigators

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

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: February 2022