Clinical Trials | A phase 1/2 study of Anti-PSMAXCD28 with or without Anti-PD-1 in patients with metastatic castration-resistant prostate cancer and other tumors associated with PSMA expression

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with metastatic prostate cancer or metastatic renal cell carcinoma to participate in a research study. This study will evaluate the effectiveness of Anti-PSMAXCD28. Anti-PSMAXCD28 is investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA) or any other health authority for marketing for any condition. Some participants may also receive an additional study drug (Anti-PD-1) in combination with Anti-PSMAXCD28 if their cancer worsens. Anti-PD-1 is approved in multiple countries to treat adult patients with different cancer types, however it has not been approved by any health agency to treat prostate or renal cancer and it has not been approved for use in combination with Anti-PSMAXCD28. Anti-PSMAXCD28 (with or without Anti-PD-1) is being studied for the treatment of previously treated prostate cancer or metastatic renal cell carcinoma. This study is being done to learn about the safety of Anti-PSMAXCD28 and find out what dose of Anti-PSMAXCD28 can be given in patients with prostate cancer and metastatic renal cell carcinoma. An additional purpose of the study is to look for signs that Anti-PSMAXCD28 can help your immune system reduce or destroy your tumor. The study involves receiving the investigational study drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the study doctor. If you are eligible for the study and consent to participate, your involvement includes a screening period of up to 28 days, a treatment period of a series of 6-week cycles, two follow-up visits after treatment, and a follow-up period via phone calls to keep track of how you are doing. Some participants may have follow-up imaging scans – these would be at a similar interval to routine scans. How long you will be on the study depends on your ability to safely tolerate the study drugs, your response to the study drugs, and your and/or your study doctor’s decision for you to continue in the study. Anti-PSMAXCD28 and Anti-PD-1 will be provided by the sponsor at no cost to you. All additional study procedures, including laboratory tests, physical examinations, and visits to the study center are provided to you at no charge. Additional information can be found here: https://www.clinicaltrials.gov/study/NCT03972657 [email protected]