Phase 2 Research Study for those with advanced peritoneal malignancies

IRB/UVA Tracking #
20681
Principal Investigator
Linda R Duska
Contact
Anne Gabel
Contact Email
Contact Phone
434.982.6657
Official Trial Title
A Phase 1/2 dose escalation study with expansion cohorts to investigate the safety, biologic and anti-tumor activity of ONCOS-102 in combination with durvalumab in subjects with advanced peritoneal malignancies
Study Description

The UVA Cancer Center seeks adults ages 18 and over, who have epithelial ovarian cancer or metastatic (spread to other parts of your body) colorectal cancer including cancers originating from the appendix that did not respond to platinum therapy or returned after treatment, for a clinical trial.

The purpose of this study is to evaluate the safety and determine the appropriate dose of the investigational combined treatment of the immunotherapy drug (Durvalumab) with an oncolytic virus drug (ONCOS-102) for patients with your type of cancer. This oncolytic virus drug selectively replicates inside the tumor and kills cancer cells. Disease response and the side effects will be studied as part of this clinical trial.

Treatment will be a little over 1 year*, followed by 3 follow-up visits (one visit per month for 3 months).
*If your doctor finds that the treatment is helping you, you may continue treatment passed the 12 study cycles.

If you are eligible and choose to participate, the study-related drugs (Durvalumab and ONCOS-102) will be provided free of charge. Additionally, the cost of the research-specific lab and immunologic tests, ECG and tumor biopsy will not be billed to you or your insurance plan. You and/or your health plan/insurance company will be responsible for the standard costs of the medical care you get as part of the study, just as you would if you were getting the usual care for your cancer.

If you live greater than 50 miles from UVA Emily Couric Cancer Center you will be reimbursed for mileage according to the rate set by the state of Virginia. If you require overnight visits for the study you will be reimbursed for lodging for up to 4 nights. If you live less than 50 miles, you will be responsible for the cost of travel to come to any study visit and for any parking costs.

Additional information can be found here: NCT02963831

Compensation

No Compensation