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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02865135

Collaborator

Stand Up To Cancer (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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

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 :

Dec 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 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 Names: HPV vaccine

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 Names:

HPV vaccine

Outcome Measures

Primary Outcome Measures

Number of Participants Experiencing Adverse Events Related to Treatment [2 years]

Secondary Outcome Measures

Overall Response Rate [2 years]
Overall Survival Rate [2 years]
Progression Free Survival Rate [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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