MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer

Date Added
December 6th, 2024
PRO Number
Pro00137019
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Men's Health, Women's Health
Summary

This study utilizes adjuvant therapy in patients identified with urothelial cancer. Patients will be tested and screened to determine eligibility. Once they are deemed eligible and have consented to treatment, the study will begin. There are regular CT / MRI scans, blood draws, testing and drug administration that occurs while on this study, including while in post-treatment follow up. The study has seperated patients into Cohorts A and B. The study lasts approximately 5 years, with 2 years dedicated to regular treatment, and 3 to post-treatment follow up observation.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase 3, Randomized Study of CG0070 versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor

Date Added
November 7th, 2024
PRO Number
Pro00137188
Researcher
Robert Grubb

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

The study is for patients that have been diagnosed with bladder cancer. Cretostimogene Grenadenorepvec is the study drug that is being utilized. The primary purpose is to evaluate the recurrence free survival (RFS) of transurethral resection of bladder tumor (TURBT) followed by cretostimogene versus TURBT followed by observation in participants with intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC). The subject may remain in the study for up to 24 months. They may receive additional treatment beyond 24 months if they are tolerating and showing benefit from the treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincial-trials@musc.edu

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

Date Added
August 30th, 2024
PRO Number
Pro00136410
Researcher
Theodore Gourdin

List of Studies


Keywords
Bladder, Cancer, Cancer/Genitourinary
Summary

This research study primarily aims to determine if BT8009 alone and when given in combination with pembrolizumab works against urothelial cancer for patients who previously received treatment for their locally advanced or metastatic cancer.
This research study also aims to understand the side effects of BT8009 when given alone and in combination with pembrolizumab.
The study drug BT8009 is investigational (i.e., experimental). An investigational drug is one that has not been approved by the Regulatory Authority to treat a certain condition or illness or a certain type of patient.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

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

Date Added
August 27th, 2024
PRO Number
Pro00138907
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients with metastatic renal cell carcinoma (RCC). The study is being done to compare overall survival (OS) between patients receiving standard systemic therapy (ST) right away versus delaying systemic therapy and instead starting with irradiation (SAbR) to all metastatic sites and reserving systemic therapy when/if the patient progresses. Also, compare the average AE score between SAbR+ST arm and ST only arm. The study drugs being used as ST are standard of care. Patients will expect to remain in the study for up to 24 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection (Pathfinder)

Date Added
August 16th, 2024
PRO Number
Pro00135932
Researcher
Robert Grubb

List of Studies


Keywords
Bladder, Cancer, Cancer/Genitourinary
Summary

The purpose of this research study is to see how effective the use of copper Cu 64 PSMA I&T Injection is in imaging prostate cancer tumors for staging of men with newly diagnosed intermediate or high risk prostate cancer who are planned to have radical prostatectomy with pelvic lymph node dissection. Three hundred twenty-three (323) patients are planned for enrollment in this Phase 3 study, at approximately 60 sites in the U.S. and Europe. Copper Cu 64 PSMA I&T Injection is an investigational imaging agent, given to you via IV injection, that may make tumors from prostate cancer show up better during a nuclear medicine imaging scan. The imaging scan is a type of nuclear medicine imaging test, which means it uses a radioactive drug and a special camera to create pictures of your tumor(s). Copper Cu 64 PSMA I&T Injection is investigational in the United States which means that the U.S. Food and Drug Administration (FDA) has not yet approved it.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

uTRACT Jelmtyo® Registry

Date Added
December 19th, 2023
PRO Number
Pro00132320
Researcher
Karthik Tanneru

List of Studies

Keywords
Cancer/Genitourinary
Summary

The purpose of this registry study is to gather more information to answer research questions about upper tract urothelial carcinoma (UTUC) and the use of Jelmyto as a treatment. Jelmyto is not an experimental medication. It has been approved by the Food and Drug Administration (FDA) in the United States for the treatment of low grade UTUC since April 2021. For this study, data will be collected from the medical record including type and location of UTUC, treatments and surgeries received, and health status following treatments and surgeries. Approximately 400 people will participate in this study. Participation in this study will last three (3) years.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Karthik Tanneru
843-673-7525
tanneru@musc.edu

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

Date Added
October 24th, 2023
PRO Number
Pro00128893
Researcher
Stephen Savage

List of Studies


Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

The study is for patients that have been diagnosed with carcinoma in situ of the bladder (localized bladder cancer, also called "non-muscle invasive bladder cancer") with or without Ta-T1 papillary disease (Ta means that the cancer is only in the innermost layer of the bladder lining, T1 means that the cancer has started to grow into the connective tissue beneath the bladder lining). The investigational drug used in this study is ONCOFID-P-B. The main purpose of this study is to understand if the study medicine ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from the standard BCG treatment and are not candidates for radical cystectomy. Participants can expect to be in this study for up to 4 years and will include a screening period of up to 4 weeks followed by up to 33 study visits to the study site.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)

Date Added
July 30th, 2023
PRO Number
Pro00129939
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal, Cancer/Genitourinary
Summary

This study is for patients with neuroendocrine carcinoma (NEC) originating outside of the lung. This study is being done to see if the combination of atezolizumab, an immunotherapy drug, with a platinum drug (cisplatin or carboplatin) and etoposide better or worse than a platinum drug and etoposide for patients with advance or metastatic neuroendocrine carcinoma originating outside the lung

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

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

Date Added
June 1st, 2023
PRO Number
Pro00118327
Researcher
Robert Grubb

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

The study is for patients that have been diagnosed with low-grade non-invasive upper tract urothelial cancer. The investigational drug used in this study is padeliporfin which is injected into a vein. The main purpose of this study is to learn about the effects and safety of an investigational treatment named padeliporfin Vascular Targeted Photodynamic (VTP) Therapy, in treating low-grade non-invasive upper tract urothelial cancer. Participants can expect to be in this study for up to 18 months. The completion of the study will include up to 9 study visits to the study site and 8 phone visits.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincial-trials@musc.edu

Phase II Trial of Sparing the Urethra, Pudendal Artery and Rectum During Stereotactic Ablative Body Radiotherapy (SUPR-SABR) for Low and Intermediate Risk Prostate Cancer

Date Added
April 18th, 2023
PRO Number
Pro00125210
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Cancer/Other, Men's Health, Prostate
Summary

This study is for subjects that have been diagnosed with prostate cancer, and their doctor has recommended external beam radiation therapy. The purpose of the study is to evaluate the side effects of a shorter course of radiation called stereotactic ablative body radiotherapy (SABR). The expected duration of the study is up to 28 months including one to four months prior to radiation therapy for treatment preparation, two weeks during radiation therapy, and 24 months after radiation therapy.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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