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Carcinoma, Transitional Cell clinical trials

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NCT ID: NCT03013920 Completed - Clinical trials for Urothelial Carcinoma

CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma

Start date: August 2016
Phase:
Study type: Observational

Rationale: Initial evaluation usually consists of cross sectional imaging of the urinary tract. When a suspect lesion is seen, an ureterorenoscopy is planned to visualize the lesion and to collect tissue for histopathology. These techniques are considered to be the gold standard in diagnosis of UTUC. CLE, a high resolution imaging technique that can be used in combination with endo-urological procedures, seems promising to improve diagnosis of urothelial cancer. CLE image characteristics for UTUC still have to be defined. Objective: With this IDEAL stage 2b explorative pilot study the investigators aim to assess in-vivo CLE image characteristics of normal urothelium, benign urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract by qualitatively comparing CLE images with both histopathology from diagnostic biopsies and pathology from the therapeutic radical nephroureterectomy. Secondary objectives are the development of an imaging atlas and to assess the technical feasibility and procedure related adverse events of CLE.

NCT ID: NCT03013894 Completed - Clinical trials for Urothelial Carcinoma

Confocal Laser Endomicroscopy in the Lower Urinary Tract

Start date: March 2016
Phase:
Study type: Observational

Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging technique, that can be used combined with endo-urological procedures, seems promising to improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic applied confocal laser endomicroscopy (CLE) still has to be defined. Objective: To directly correlate CLE images with histopathology, and identify and define CLE characteristics of normal urothelium, benign bladder urothelium, and bladder tumors (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract. Primary objective: to develop descriptive image interpretation criteria and a classification of CLE images of bladder tissue through a review of prospectively obtained CLE videos from bladder tissue correlated with histopathology. Secondary objectives: - Assessing procedure related adverse events of CLE - Assessing technical feasibility of CLE - To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign, low-grade or high-grade and CIS)

NCT ID: NCT02989064 Completed - Clinical trials for Head and Neck Cancer

MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers

Start date: October 2016
Phase: Phase 1
Study type: Interventional

This Phase 1 study is designed as a cell dose escalation trial in HLA-A*02:01 and HLA-A*02:06 subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation design, to evaluate dose limiting toxicities and determine the target cell dose range. Following the dose escalation phase, additional subjects will be enrolled at the target cell dose range to further characterize safety and the effects at this cell dose. The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. When the MAGE-A10ᶜ⁷⁹⁶T cells are available, subjects will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with urothelial, melanoma or head and neck cancer. Subjects will be seen frequently by the Study Physician after receiving their T cells for the next 6 months. After that, subjects will be seen every 3, 6, or 12 months according to the Schedule of Procedures. All subjects completing or withdrawing from the interventional portion of the study will enter a long term follow-up phase for observation of delayed adverse events and overall survival for 15 years post-infusion.

NCT ID: NCT02986867 Completed - Melanoma Clinical Trials

SAbR Induced Innate Immunity in Urothelial Carcinoma, Melanoma, and Cervical Carcinoma

Start date: June 13, 2017
Phase: N/A
Study type: Interventional

The study is an exploratory prospective, single center study with correlative endpoints. The study will investigate the association of tumor cGAS STING signaling with SAbR. Tumor core biopsies will be processed and analyzed as described above. Medical records electronic medical records will be used to collect demographic and medical information and imaging studies.

NCT ID: NCT02983045 Completed - Gastric Cancer Clinical Trials

A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors

PIVOT-02
Start date: December 19, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.

NCT ID: NCT02897765 Completed - Lung Cancer Clinical Trials

A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer

Start date: October 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate if the treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and useful for patients with certain types of cancer. The study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a substantial improvement over other available therapies such as nivolumab alone. All eligible patients will receive NEO-PV-01 + adjuvant and nivolumab while on this trial.

NCT ID: NCT02876861 Completed - Clinical trials for High-Grade Upper Tract Urothelial Carcinoma

Neoadjuvant Chemotherapy Versus Surgery Alone in Patients With High-Grade UTUC

Start date: February 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin (GC) for 2-4 cycles can help shrink the tumor before undergoing surgery and improves the overall survival for high-grade upper tract urothelial carcinoma.

NCT ID: NCT02872714 Completed - Clinical trials for UC (Urothelial Cancer)

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

Start date: January 12, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

NCT ID: NCT02853305 Completed - Clinical trials for Urothelial Carcinoma Associated 1 RNA, Human

Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)

Start date: September 15, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of pembrolizumab (pembro, MK-3475) with or without chemotherapy versus chemotherapy alone in participants with advanced or metastatic urothelial carcinoma (bladder cancer). The primary hypotheses are that pembrolizumab plus chemotherapy is superior to chemotherapy alone with respect to Progression-free Survival (PFS) and Overall Survival (OS) in all participants, and that pembrolizumab alone is superior to chemotherapy alone with respect to OS in all participants and in participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥10%).

NCT ID: NCT02818725 Completed - KRAS Gene Mutation Clinical Trials

I-MVAC +/- Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma Without H-Ras Nor K-Ras Mutations

GETUG-AFU19
Start date: June 2010
Phase: Phase 3
Study type: Interventional

OBJECTIVES OF THE TRIAL Primary objective Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations. Secondary objectives - To assess toxicity - To assess response rate - To assess overall survival - To assess time to progression - To study the correlation between response rate, time to progression, overall survival and biological parameters