Expanded Access of Vigil in Solid Tumors

Plain-language summary

This is an expanded access study involving an investigational product named Vigil. Vigil is considered immunotherapy. Patients who participated in another clinical trial sponsored by Gradalis, and had Vigil made from their tumor tissue removed from a standard operation, however failed the criteria to enroll in the other clinical trial to receive Vigil are eligible to screen for this expanded access trial to receive the Vigil made from their cancer cells. In this study, eligible participants will receive intradermal (under the skin) injections of Vigil, once every 4 weeks (28 days) for 1-12 doses, depending on the number of doses that was made from the cancer cells and if the participant is clinically stable. During the treatment portion of the study, in addition to receiving Vigil injections, participants will also have a physical exam, blood collection for routine and research tests, and assessment of medications, adverse events, and performance status information will be collected. Radiological tumor assessments will be performed every 3 months from Cycle 1. Once treatment ends, participants will continue to be seen in the clinic every 3 months for similar assessments until disease progression occurs. After disease progression, participants will be contacted by phone 4 times a year to determine post study treatment and survival status information.

Who can participate

Trial details