Genitourinary Cancer Trials
Every treatment that has ever made a difference in cancer care was once a part of a clinical trial. MUSC Hollings Cancer Center is committed to offering the best treatments available today while searching for even better ones for the future. Ask your doctor if a clinical trial is right for you.
STUDY13017
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
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.
Study InformationSTUDY13684
A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.
Study InformationSTUDY14071
InPACT International Penile Advanced Cancer Trial (International Rare Cancers Initiative study)
This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions.
Study InformationSTUDY17022
First in Human, Phase 1/1b, Open label, Multicenter Study of Bifunctional EGFR/TGF ß Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients with EGFR Driven Advanced Solid Tumors
The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.
Study InformationSTUDY18068
Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer
This is a phase 3, open label, single arm study of TOOKAD in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade upper tract urothelial carcinoma in either the kidney or the ureter. The patients will be treated with TOOKAD (padeliporfin) VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase.
Study InformationSTUDY18589
A Phase III Randomized Trial of Eribulin (NSC #707389) with or without Gemcitabine Versus Standard of Care (Physician s Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy
This phase III trial compares the usual chemotherapy treatment to eribulin alone and to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, and paclitaxel, 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. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.
Study InformationSTUDY18866
T-reg function changes: a novel immune regulatory effect underlying benefit of statin use on lethal prostate cancer
To evaluate whether men diagnosed with localized prostate cancer randomized to receive a statin prior to prostatectomy have greater intraprostatic YAP-mediated T-reg dysfunction compared to men randomized to the control group. To determine whether men randomized to the statin group have greater YAP-mediated T-reg dysfunction compared to men randomized to the control group restricting to tumor-infiltrating T-regs only. To determine whether men randomized to the statin group have greater YAP-mediated T-reg dysfunction compared to men randomized to the control group restricting to the subset of T-regs in the adjacent normal and stromal tissue area. To determine whether men randomized to the statin group have greater intraprostatic anti-tumor immune response compared to men randomized to the control group.
Study InformationSTUDY20908
Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)
This phase III trial compares the addition of apalutamide, with or without targeted radiation therapy, to standard of care treatment versus standard of care treatment alone in patients with prostate cancer biochemical recurrence (a rise in the blood level of prostate-specific antigen [PSA] after treatment with surgery or radiation). Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT), may help doctors look for cancer that has spread to the pelvis. Androgens can cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET/CT results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
Study InformationSTUDY21781
A Phase 1 Dose Escalation Study of AV-380 in Combination with Standard of Care Chemotherapy in Metastatic Cancer Patients with Cachexia and Elevated GDF-15 Levels
To refine the dose and schedule of AV-380 and establish its adverse event (AE), pharmacokinetic (PK), and pharmacodynamic (PD) profile in metastatic cancer patients with cachexia and elevated GDF-15, receiving SoC chemotherapy for metastatic cancer
Study InformationSTUDY22468
A Phase III, Single Arm Study to Evaluate the Efficacy and Safety of ONCOFID P B (paclitaxel hyaluronic acid conjugate) Administered Intravesically to Patients with BCG unresponsive Carcinoma in Situ of the Bladder with or without Ta T1 Papillary Disease
To evaluate the antitumor activity of ONCOFID-P-B using centrally assessed complete response rate (CRR) following 12 weekly intravesical instillations (induction phase). To further evaluate the antitumor activity of ONCOFID-P-B using centrally assessed CRR at 6, 9, 18 and 24 months after treatment start. To evaluate the duration of response (DoR). To evaluate the DoR rates at 6, 9, 12, 15, 18, 21 and 24 months after treatment start. To evaluate progression rates at 3, 15 and 24 months after treatment start. To evaluate time to progression. To evaluate the rate of patients undergoing cystectomy at 3, 15 and 24 months after treatment start. To evaluate event-free survival (EFS). To evaluate overall survival (OS).
Study Information