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Urothelial Cancer clinical trials

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NCT ID: NCT05366725 Active, not recruiting - Urothelial Cancer Clinical Trials

A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy

Start date: June 29, 2022
Phase:
Study type: Observational

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Avelumab) in people with advanced urothelial (bladder) cancer (UC) whose disease hasn't worsened after receiving chemotherapy. This study is seeking participants who: 1. Have UC that cannot be operated on or has spread to other parts of the body 2. Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment 3. Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy 4. Are 18 years or older on the date that they start taking Avelumab All participants in this study will receive Avelumab, a standard treatment for urothelial carcinoma. Participants will take part in this study for about 4 years. During this time, they will take Avelumab as instructed in the real-world setting. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe and effective.

NCT ID: NCT05059522 Active, not recruiting - Ovarian Cancer Clinical Trials

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

Start date: September 29, 2021
Phase: Phase 3
Study type: Interventional

This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

NCT ID: NCT04724018 Active, not recruiting - Bladder Cancer Clinical Trials

Sacituzumab Govitecan Plus EV in Metastatic UC

Start date: May 20, 2021
Phase: Phase 1
Study type: Interventional

This research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). The names of the study drugs in this investigational combination are: - Enfortumab Vedotin - Sacituzumab Govitecan

NCT ID: NCT04152018 Active, not recruiting - Ovarian Cancer Clinical Trials

Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

Start date: November 13, 2019
Phase: Phase 1
Study type: Interventional

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B) and dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.

NCT ID: NCT03983954 Active, not recruiting - Prostate Cancer Clinical Trials

Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors

Start date: October 10, 2019
Phase: Phase 1
Study type: Interventional

This is a dose escalation, MTD expansion (Phase 1b) and cohort expansions (Phase 2) study to assess the safety and tolerability of a combination of NAP with durvalumab in subjects with selected advanced or metastatic solid tumors.

NCT ID: NCT03474107 Active, not recruiting - Bladder Cancer Clinical Trials

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

NCT ID: NCT03425201 Active, not recruiting - Urothelial Cancer Clinical Trials

Niraparib in Combination With Cabozantinib (XL184) in Patients With Advanced Urothelial Cancer (NICARAGUA)

NICARAGUA
Start date: October 14, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Cabozantinib is an oral, small-molecule tyrosine kinase inhibitor. Its primary targets are Hepatocyte growth factor receptor protein (MET), vascular endothelial growth factor receptor 1-3 (VEGFR1-3), RET, AXL, FLT3 and KIT. Cabozantinib has been approved by the FDA for clinical treatment of progressive, metastatic medullary thyroid cancer. Recently published trials have demonstrated activity for cabozantinib in patients with advanced renal cell carcinoma and metastatic castration-resistant prostate cancer (mCRPC). Furthermore, in preclinical models of urothelial carcinoma (UC) of the bladder, cabozantinib has demonstrated the ability to inhibit tumor xenograft growth. It has been suggested that levels of soluble Met ectodomain (sMet) can be measured in the urine as a useful biomarker to monitor the efficacy of c-Met therapy in bladder cancer patients. Moreover, cabozantinib has demonstrated activity in heavily pretreated, advanced bladder cancer patients, with a response rate of 19.5% and manageable toxicities. In the phase I of this study it is proposed to evaluate DLTs of niraparib and cabozantinib combination and determine maximum tolerated dose (MTD) in patients with advanced urothelial or renal cell carcinoma. In the phase II it is proposed to make a preliminary evaluation of the efficacy of this combination in patients with urothelial cell carcinoma. Efficacy results will be correlated with genomic alterations related to c-Met and Poly [ADP-ribose] polymerase (PARP) inhibitor activity.

NCT ID: NCT03406650 Active, not recruiting - Urothelial Cancer Clinical Trials

Neoadjuvant and Adjuvant Durvalumab in Combination With Neoadjuvant Chemotherapy in Patients With Operable Urothelial Cancer.

SAKK 06/17
Start date: May 15, 2018
Phase: Phase 2
Study type: Interventional

The main objective is to demonstrate that the addition of neoadjuvant and adjuvant immunotherapy with durvalumab, to standard neoadjuvant chemotherapy (with cisplatin/gemcitabine) and surgery in urothelial carcinoma could improve event-free survival.

NCT ID: NCT03390504 Active, not recruiting - Urothelial Cancer Clinical Trials

A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

THOR
Start date: March 23, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).

NCT ID: NCT03288545 Active, not recruiting - Clinical trials for Urinary Bladder Neoplasms

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

EV-103
Start date: October 11, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.