Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cerv… (NCT02865135) | Clinical Trial Compass
CompletedPhase 1/2
Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer
United States11 participantsStarted 2017-03-30
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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);…
What they're measuring
1
Number of Participants With Dose Limiting Toxicity (DLT) [Phase 1b]
Timeframe: Patients were followed for 50 days.
2
Grade 1-2 Treatment-Related AE Rate
Timeframe: The median follow up was 2.92 months (range 1.25 - 5.88months).
3
Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue