A Randomized Phase IIa study of Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury) Vaccine (Tri-Ad5) in Lynch syndrome, INT21-05-01

ClinCaP participates in this trial that is administered by the M.D. Anderson Consortium and the co-PIs are Eduardo Vilar-Sanchez, M.D., Ph.D. (M.D. Anderson) and Ajay Bansal, M.D. (University of Kansas). At ClinCaP, the trial will start at University of Michigan and Cleveland Clinic initially and then add Ohio State, University of North Carolina and University of Kansas after the first year.

Obeticholic Acid for Chemoprevention in Barrett’s Esophagus, MICH20-03-01

This trial is administered by ClinCaP and the protocol PI is Prashanthi Thota, M.D., at Cleveland Clinic. The trial will be conducted at the following sites: 1) Case Western Reserve, 2) Cleveland Clinic, 3) University of Michigan, 4) University of Kansas, 5) University of North Carolina and 6) Washington University.

A Randomized Trial of Apalutamide in Non-Muscle Invasive Bladder Cancer, UWI22-09-01

This trial approved for conduct through ClinCaP is administered by the University of Wisconsin consortium, and the protocol PI is Edward Messing, M.D., at University of Rochester. Ohio State University will be the participating affiliated site from ClinCaP with Debasish Sundi, M.D., as the site PI.

Phase IIA Trial of Acolbifene (20 mg) vs Low Dose Tamoxifen (5 mg) in Pre-menopausal Women at High Risk for Development of Breast Cancer, UMI22-09-01

This trial is administered by ClinCaP. Carol Fabian, M.D., and Bruce Kimler, Ph.D. from University of Kansas Medical Center are the protocol co-PIs. This trial will be conducted at the University of Kansas, Ohio State University, City of Hope Medical Center and Northwestern University

ONC201 for Chemoprevention in Colorectal Cancer, UMI22-09-022

This trial is administered by ClinCaP, and Alexander Raufi, M.D., at Brown University is the protocol PI. The trial will be conducted at Rhode Island Hospital, University of Michigan, University of North Carolina, and Ohio State University. Central pathology review will be at Case Western Reserve University.