Approved Trials

A Randomized Phase 2a study of Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury) Vaccine (Tri-Ad5) in Lynch syndrome

INT21-05-01

ClinCaP participates in this inter-consortium 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). ClinCaP administers the trial at University of Michigan, Cleveland Clinic, Ohio State, and University of North Carolina.

Obeticholic Acid for Chemoprevention in Barrett’s Esophagus

UMI21-05-01

This trial is administered by ClinCaP and the protocol PI is Prashanthi Thota, M.D., at Cleveland Clinic. The trial is being conducted at the following sites: Case Western Reserve, Cleveland Clinic, University of Michigan, University of Kansas, University of North Carolina and Washington University.

A Randomized Trial of Apalutamide in Non-Muscle Invasive Bladder Cancer

INT22-09-01

ClinCaP participates in this inter-consortium trial that is administered by the University of Wisconsin consortium. The protocol PI is Edward Messing, M.D., at University of Rochester. Ohio State University is the participating affiliated site administered by ClinCaP with Debasish Sundi, M.D., as the site PI.

Phase 2 Study of Low Dose Tamoxifen +/- High Dose EPA & DHA Omega-3 Fatty Acids in Obese Postmenopausal Women at Increased Risk for Breast Cancer

UMI23-14-02

This trial is administered by ClinCaP. Lauren Nye, M.D. from University of Kansas Medical Center is the protocol PI. This trial will be conducted at the University of Kansas and the Ohio State University (Sagar Sardesai, M.D., M.P.H., site PI).

ONC201 for Chemoprevention in Colorectal Cancer

UMI22-09-02

This trial is administered by ClinCaP, and Alexander Raufi, M.D., at Brown University is the protocol PI. This Phase 1 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.

Repurposing Itraconazole for Secondary Prevention of Metaplasia and Primary Prevention of Cancer in Patients with High-Risk Barrett’s Esophagus after Ablation

UMI23-16-01

This Phase 2 trial is administered by ClinCaP. Ajay Bansal, M.D., at University of Kansas, and David Wang, M.D., Ph.D, are the protocol co-PIs. The trial will be conducted at University of Michigan, Case Western Reserve University, Cleveland Clinic, Baylor Scott & White Center of Esophageal Disease, University of North Carolina, and Washington University in St. Louis. Central pathology review will be at Case Western Reserve University.

A Phase 0 Trial of Omeprazole and Low Dose Aspirin to Identify Pharmacodynamic Biomarkers of Preventive Efficacy

UMI23-13-01

This trial is administered by ClinCaP. Zora Djuric, Ph.D., and Elena Stoffel, M.D., M.P.H., at University of Michigan are the protocol co-PIs. The trial is being conducted at University of Michigan and Ohio State University (Peter Stanich, M.D., site PI). Central pathology review is at Case Western Reserve University.

A Phase 1a/b Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

UMI23-15-01

This trial is administered by ClinCaP. Samara Rifkin, M.D., at University of Michigan, Carol Burke, M.D., at Cleveland Clinic, and Lee Jones, Ph.D., at Memorial Sloan Kettering University are the trial PIs. The trial will be conducted at University of Michigan, Memorial Sloan Kettering, and Cleveland Clinic. Central pathology review will be at Case Western Reserve University.

Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, Renaissance

INT23-14-01

This protocol PI for this inter-consortium trial is Seema Khan, M.D., at Northwestern University. ClinCaP administers the trial at Ohio State University and University of Michigan.

Acolbifene versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopasual Women at High Risk for Breast Cancer 

UMI22-09-01

This trial is administered by ClinCaP. Carol Fabian, M.D., is the protocol PI and Bruce Kimler, Ph.D., is the co-PI. The trial is being conducted at University of Kansas, City of Hope, and Ohio State University.