A Phase 2 interventional study of Tableted vaccine (V3-OVA) containing ovarian cancer antigens in Ovarian Cancer, sponsored by Immunitor LLC. Status unknown at 1 site in Mongolia. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-30.
Sponsored by Immunitor LLC · Phase 2, Interventional, and Treatment
This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumors of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.
Ovarian cancer (OC) - a malignant disease affecting the ovarian tissue - is the sixth most diagnosed cancer among women and causes more deaths than any other cancer of the female reproductive system. For treatment of OC, surgical intervention, chemotherapy, as well as radiation methods are used. Despite treatment, about 70% of patients have a relapse. Many different types of immunotherapy (especially checkpoint inhibitors) of OC being tested, but so far the successes have been insignificant, and serious side effects are frequent and unpredictable. This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 20 is below the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Immunitor LLC is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Confirmed diagnosis of ovarian cancer Positive for CA125 tumor marker at above normal threshold level -
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral once daily pill of tableted vaccine (V3-OVA) containing ovarian cancer antigens administered for 3 months in 20 volunteers with ovarian cancer
Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens
One pill of V3-OVA per day for three months
Also known as: V3-OVA
Changes in tumor size and burden compared to baseline
Intravaginal ultrasonography to measure changes in tumor size and burden
Time frame: Monthly for 3 months
Effect on level of serum tumor markers compared to baseline
Commonly measured tumor markers associated with ovarian cancer, primarily CA125, at baseline and at study termination
Time frame: Monthly for three months
Plan to share: No — Data will be shared upon study completion in peer-reviewed publication
No publications or documents are linked to this record.
Started Jul 2018 (actual). Primary completion is estimated for Nov 2019, 16 months after the start.
Of 116 industry-sponsored phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 51. This study's planned 16 months is below that.
Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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