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.

 ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05053152?term=NCT05053152&rank=1

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.

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06225596?term=NCT06225596&rank=1

23.0821:  Study Title:  A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer 

Principal Investigator: Abigail Chan, MD 

Phase:  II 

Description:  This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. 

More Info:  https://clinicaltrials.gov/study/NCT05610163?term=NCT05610163&rank=1

23.0795:  Phase III Randomized Trial of Stereotactic ablative radiotherapy (SAbR) for ligometastatic Advanced Renal Carcinoma (SOAR) 

Principal Investigator: Scott Silva, MD, PhD 

Phase:  III 

Description:  This phase III trial compares the effect of stero-ablative radiotherapy (SAbR) followed by standard of care systemic therapy, to standard of care systemic therapy alone, in patients with kidney cancer that has spread from where it first started (primary site) to a limited (2-5) number of places in the body (metastatic). Study doctors want to find out if this approach is better or worse than the usual approach for metastatic kidney cancer. The usual approach is defined as the care most people get for metastatic kidney cancer which includes systemic therapy such as immunotherapy (given through the veins) and/or small molecular inhibitor (tablets taken by mouth). Radiotherapy uses high energy x-rays to kill cancer cells and shrink tumors. SAbR uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving SAbR prior to systemic therapy may kill more tumor cells than the usual approach, which is systemic therapy alone. 

More Info:  https://clinicaltrials.gov/study/NCT05863351?term=NCT05863351&rank=1

23.0760:  PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT)

Principal Investigator: Rohit Kumar, MD 

Phase:  III 

Description:  This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT04513717?term=NCT04513717&rank=1

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. 

More Info:  https://clinicaltrials.gov/study/NCT05318573?term=NCT05318573&rank=1

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).

More Info:  https://clinicaltrials.gov/ct2/show/NCT05536141?term=NCT05536141&draw=2&rank=1

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.

More info:  https://clinicaltrials.gov/ct2/show/NCT03678025?term=NCT03678025&rank=1

 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.