Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02933073|
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Biological: OncoImmunome||Phase 1|
The study will be conducted under an IRB approval, in accordance with FDA regulations and Human Subject Protection regulations. Female patients will undergo standard of care therapy to include exploratory laparotomy and cytoreduction (debulking) surgery followed by chemotherapy. Only patients with histological confirmation of FIGO Stage III/IV epithelial adenocarcinoma of ovarian, tubal or peritoneal origin will be screened and enrolled into the study. At cytoreduction surgery a portion of the surgically resected tumor is preserved for vaccine production. The surgically resected tumor as well as normal cells obtained from peripheral blood shall be used for extraction of RNA and DNA sequencing of the tumor and normal transcriptomes, as well as normal exome sequencing, in the Genomic Core Facility at UConn Health. Patient's blood cells shall also be HLA typed.
When the patient has recovered from surgery, standard of care chemotherapy is given. Following completion of standard chemotherapy (6-8 cycles) and Investigator's confirmation of clinical remission, patients will be consented as subjects for the experimental investigative portion of the study.
The overall purpose of this research study is to produce and test the safety of a new experimental vaccine called OncoImmunome in people with Stage III/IV Ovarian Cancer. An "experimental vaccine" is a vaccine that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). The study has been divided into two parts: 1)Tumor Tissue and Blood Sample Collection and 2) Vaccine and Follow-up.
Study participants will consent to the following:
- Tumor Tissue and Blood Sample Collection: The purpose of this part of the study is to collect participants' blood and tumor tissue and test it for genetic mutations. These test results will be used to manufacture a study vaccine that is unique to the participant and to their ovarian cancer.
- Vaccine and Follow-up: The purpose of this part of the study is to test the safety of the experimental drug (vaccine) called OncoImmunome, which has been produced specifically for each participant.
Subject participation in this research study will last up to 5 years. The vaccine will be produced over a 6 month period, and for six months subjects will receive the study vaccine (1 study vaccine dose per month or 6 study vaccine doses total). However, the researchers will continue to collect all subjects information for up 5 years from the time they provided their tumor sample and blood for the research.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||October 2026|
|Estimated Study Completion Date :||October 2026|
Experimental: OncoImmunome/Vaccine Phase
Women with Stage III/IV Ovarian Cancer who have received the standard of care treatment (surgical debulking and chemotherapy) for their cancer and are now in clinical remission will be given the experimental drug (vaccine) called OncoImmunome, which has been produced specifically for each participant.
The OncoImmunome will be a substance composed of a mixture of seven to ten peptides each containing 17-18 amino acids. Given that the vaccine will be tumor-specific based upon mutant peptide sequences identified in each tumor transcriptome, the vaccine for each patient will likely be a unique composition.
- Monitoring of treatment-related adverse events as assessed by CTCAE v4.0 in subjects immunized with Oncoimmunome [ Time Frame: 5 years ]Number of Participants with Oncoimmunome Immunization related Adverse Events (AE) as assessed by CTCAE v. 4.03.
- Monitoring of subjects immunized with Oncoimmunome for immune response to components of Oncoimmunome [ Time Frame: 5 years ]1) Measurement of CD8 T cell proliferation and T cell phenotype in response to the Oncoimmunome peptides in immunized subjects
- Monitoring of subjects immunized with Oncoimmunome for progression-free survival. [ Time Frame: 5 years ]Progression-free survival of patients immunized with Oncoimmunome.
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): NCT02933073
|Contact: Quratulain Ali, MPH, CCRPfirstname.lastname@example.org|
|United States, Connecticut|
|Farmington, Connecticut, United States, 06032|
|Contact: Quratulain Ali, MPH, CCRP 860-679-7648 email@example.com|
|Principal Investigator: Susan Tannenbaum, MD|
|Principal Investigator:||Susan Tannenbaum, MD||UConn Health|