Specialized Urology Profile - investigations

MCC15441 Study 9/13/2008 (Moffitt Cancer Center)

Resources: Foundation Funding – GU research Fund.

Title: “Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract”.

Study Role: Co-investigator. Principal investigator: Dr. Philipe E. Spiess

MCC 15666 Study 8/18/2008 (Moffitt Cancer Center).

Resources: Moffitt Cancer Center.

Study Role: Co-Investigator. PI – Dr. Wade Sexton.

Title “Renal Cancer: A Retrospective Review of the Patients Diagnosed and Treated at H. Lee Moffitt Cancer Center”

Objective: Develop a comprehensive kidney cancer database of all patient managed with this disease at the Moffitt Cancer Center.

CA 184095 Study (ClinicalTrials.gov Identifier: NCT02279862)

Study Role: PI In Hospital Pablo Tobon Uribe Reserch Unit.

Title: A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic.

Main Objective: The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

D4320C00015 Study (Eudra CT Number 2007-003224-38)

Study role: co-Investigator, PI in research unit, Hospital Pablo Tobón Uribe – Dr. Juan Carlos Castaño.

Title: A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients.

Main Objective: determine the effect of ZD4054 in global survival and progression free survival compared to placebo.

212082 Study PCR3011 (ClinicalTrials.gov Identifier: NCT01715285)

Study Role: co-investigator, PI in research unit Hospital Pablo Tobón Uribe – Dr. Carlos Martínez.

Title: A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC).

3104007 Study ARAMIS (ClinicalTrials.gov Identifier: NCT02200614)

Study Role: Principal investigator in research unit Hospital Pablo Tobón Uribe.

Title: A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer.

56021927 Study PCR3010 (ClinicalTrials.gov Identifier: NCT03523338)

Study role: Principal investigator in research unit Hospital Pablo Tobón Uribe.

Title: An Open-Label Expanded Access Protocol for Apalutamide Treatment of Subjects With Non Metastatic Castration-Resistant Prostate Cancer

3475-641-00 Study (KEYNOTE-641) (ClinicalTrials.gov Identifier: NCT03834493)

Study role: Principal investigator in research unit Hospital Pablo Tobón Uribe.

Title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641).

3475-921 Study (KEYNOTE-921) (ClinicalTrials.gov Identifier: NCT03834506)

Study Role: Principal investigator in research unit Hospital Pablo Tobón Uribe.

Title: A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921).

Ca 209-274 Study (CheckMate 274) (ClinicalTrials.gov Identifier: NCT02632409)

Study Role: Principal investigator in research unit Hospital Pablo Tobón Uribe.

Title: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274).

Ca 209-9KD Study (CheckMate 9KD) (ClinicalTrials.gov Identifier: NCT03338790)

Study Role: Principal investigator in research unit Hospital Pablo Tobón Uribe.

Title: A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer.