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

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Cancer of Head and Neck; Cancer of Cervix; Cancer of Anus	Drug: DPX-E7 vaccine	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 2016
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
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.	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

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Contacts and Locations

Locations

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Dana-Farber Cancer Institute

Stand Up To Cancer

Investigators

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

More Information

• Responsible Party: Kartik Sehgal, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT02865135
• Other Study ID Numbers: 15-578
• First Posted: August 12, 2016
• Last Update Posted: February 21, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Kartik Sehgal, Dana-Farber Cancer Institute:

HPV Related Head and Neck; Cervical; Anal Cancer

Additional relevant MeSH terms:

Anus Neoplasms; Head and Neck Neoplasms; Uterine Cervical Neoplasms; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs