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 : March 25, 2020
|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|
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 (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2020|
|Estimated Study Completion Date :||May 2023|
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
- Number of Participants Experiencing Adverse Events Related to Treatment [ Time Frame: 2 years ]
- Overall Response Rate [ Time Frame: 2 years ]
- Overall Survival Rate [ Time Frame: 2 years ]
- Progression Free Survival Rate [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865135
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jochen Lorch, MD||Dana-Farber Cancer Institute, Boston, MA02215|