Genitourinary Clinical Trials

25.0641:  SHORT TERM INTENSIFIED PEMBROLIZUMAB (KEYTRUDA) AND TIVOZANIB FOR HIGH-RISK RENAL CELL CARCINOMA - STRIKE

Principle Investigator

Rohit Kumar, MD

Phase

III

Description

This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.

Find more information at ClinicalTrials.gov

25.0640:  MODERN: AN INTEGRATED PHASE 2/3 AND PHASE 3 TRIAL OF MRD-BASED OPTIMIZATION OF ADJUVANT THERAPY IN UROTHELIAL CANCER

Principle Investigator

Rohit Kumar, MD

Phase

II/III

Description

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.

Find more information at ClinicalTrials.gov

25.0627:  A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients with Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (TRIPLE-SWITCH)

Principal Investigator

Rohit Mumar, MD

Phase

III

Description

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?

Find more information at ClinicalTrials.gov

25.0073:  A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 as a Single Agent in Patients with Advanced Solid Tumors with and without Microsatellite Instability and/or Deficient Mismatch Repair

Principal Investigator

Rebecca Redman, MD

Phase

I/II

Description

The goal of this clinical trial is to learn if NDI-219216 is safe for patients, and if NDI-219216 might be a possible treatment for advanced solid tumors in the later phases of the study.

Find more information at ClinicalTrials.gov

24.0835:  A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs abazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

Principal Investigator

Rohit Kumar, MD

Phase

III

Description

The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy [ARDT]).

Find more information at ClinicalTrials.gov

24.0766:  A Phase 1/1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants with Advanced/Metastatic Solid Tumors.

Principal Investigator

Rebecca Redman, MD

Phase

1/1b

Description

The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.

Find more information at ClinicalTrials.gov

24.0671:  A Phase 3, Randomized, Open-Label Study of Pf-06821497 (Mevrometostat) In Combination with Enzalutamide Compared with Enzalutamide or Docetaxel in Participants with Metastatic Castration Resistant Prostate Cancer Previously Treated with Abiraterone Acetate (Mevpro-1)

Principal Investigator

Rohit Kumar, MD

Phase

III

Description

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment.The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.

Find more information at ClinicalTrials.gov

24.0500:  A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy with or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

Principal Investigator

Scott Silva, MD, PhD

Phase

II

Description

This phase II trial tests whether relugolix and radiation therapy works to shrink tumors in patients with prostate cancer that has spread in a limited way to 1 to 5 other parts of the body (oligometastatic). Testosterone can cause the growth of prostate cancer cells. Relugolix lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Giving relugolix with radiation therapy may help lower the chance of prostate cancer growing or spreading.

Find more information at ClinicalTrials.gov

24.0043:  Study Title:  A Randomized Open-Label Phase 2 and 3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Principal Investigator

Rohit Kumar, MD 

Phase

II/III 

Description

This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC.

Find more information at ClinicalTrials.gov

23.0731:  A Phase 2a Study with Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors 

Principal Investigator

Rohit Kumar, MD 

Phase

II 

Description

This is a Phase 2a, open label clinical trial evaluating FF-10832 in combination with pembrolizumab and as monotherapy. The trial will begin with a safety run-in phase of 10 patients receiving combination therapy with pembrolizumab; FF 10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg). The dose of FF-10832 may be reduced to 30 mg/m2 and tested in 10 patients after review of safety data by a safety review committee (SRC). Lower or intermediate doses of FF-10832 may be explored if necessary After confirmation of the appropriate FF-10832 dose for use with pembrolizumab, the trial will enroll up to an additional 100 patients in 2 cohorts (urothelial cancer [UC] and non-small cell lung cancer [NSCLC]) into 4 separate expansion treatment arms (approximately 25 patients in each treatment arm). The disease-defined cohorts will be patients who have progressed on PD-1/PD-L1 therapy who have UC or NSCLC.The UC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy) and the NSCLC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy), to further establish safety and gain preliminary information on antitumor activity of FF-10832 as monotherapy or in combination with pembrolizumab. 

Find more information at ClinicalTrials.gov

22.0891:  A Phase 1, open-label, dose escalation and dose expansion study, to investigate the safety,tolerability, and pharmacokinetic profile of AB521 monotherapy in participants with clear cellrenal cell carcinoma and other solid tumors

Principal Investigator

Rohit Kumar, MD

Phase

I

Description

This is a multicenter, open-label, Phase 1 study to evaluate the safety, pharmacokinetic (PK), preliminary clinical activity, pharmacodynamic (PD), and biomarkers of AB521 as monotherapy for advanced solid tumor malignancies (dose escalation) and clear cell renal cell carcinoma (ccRCC) (dose expansion).

Find more information at ClinicalTrials.gov

19.0721:  Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

Principal Investigator

Scott Silva, MD, PhD

Phase

III

Description

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Find more information at ClinicalTrials.gov

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator

Rebecca Redman, M.D.

Description

The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.