Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Wounds and Injuries

Carcinoma

Carcinoma, Papillary

Carcinoma in Situ

Urinary Bladder Neoplasms

Hyperthermia

Fever

Non-Muscle Invasive Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Mitomycins

Mitomycin

BCG Vaccine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Bladder radiofrequency-induced hyperthermia will be delivered in combination with each instillation of MMC in accordance with the Sponsor operational guidelines.

Subjects will receive a series of induction followed by a series of maintenance bladder instillations of Synergo® RITE + MMC

Synergo® RITE + MMC

Michael A O'Donnell, MD

This study will determine whether Synergo® RITE + MMC treatment is efficacious as second-line therapy for CIS NMIBC BCG-unresponsive patients with or without papillary NMIBC, through examination of the complete response rate (CRR) and disease-free duration for complete responders. The study will also explore progression-free survival time, bladder preservation rate, and overall survival time.

The study will address an unmet need to identify a treatment effective in both ablating the disease and providing a prolonged disease-free period for patients. Ideally, the treatment will delay progression to invasive disease, thus preserving the bladder.

Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.

A Multicenter, Single-Arm Study Evaluating the Efficacy of Synergo® Radiofrequency-Induced Thermochemotherapy Effect (RITE) With Mitomycin C (Synergo® RITE + MMC) in CIS Non-Muscle Invasive Bladder Cancer (NMIBC) Bacillus Calmette-Guérin (BCG)-Unresponsive Patients With or Without Papillary NMIBC

* no CIS
* no papillary HG tumor
* no papillary T1 tumor
* no extra-vesical UC tumor
* no progression

a patient will be considered a complete responder only if all the criteria above are met.

Patients experiencing a new occurrence of a benign tumor or low-grade Ta will be allowed to continue in the study (tumor will be resected); such an occurrence will not constitute an event in the primary analysis.

Patients with tumors of the ostium and/or upper tract and/or prostatic urethra will be considered to have achieved a complete response in the primary analysis but will be removed from the study.

time of recurrence for complete response patients from the 3-month visit until the time of recurrence or until the last follow-up, whichever occurs sooner.

Medical Enterprises Ltd.

Digestive System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Breast Neoplasms

Colorectal Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Stomach Diseases

Stomach Cancer

Ovarian Cancer

Administered via intravenous (IV) infusion

ESG401

Xiaoyan Xing, PhD

Fei Ma

The primary objective in Phase I is to evaluate the safety and tolerability of ESG401 as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of ESG401 administered in 21-day treatment cycles at a dose selected in Phase I.

Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).

Study of ESG401 in Adults With Solid Tumors

An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG401 in Subjects With Locally Advanced/Metastatic Solid Tumors

Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious:

Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above

ORR is defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR will be assessed for the TNBC Target Population in phase 2 only.

Area under the serum concentration time curve from time 0 extrapolated to infinity

ORR is defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by local assessment will be assessed for the Target Population both in phase 1 and phase 2.

Progression-free survival (PFS) is defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.

Overall survival is defined as the time from the date of the first dose start date to the date of death due to any cause.

Shanghai Escugen Biotechnology Co., Ltd

Carcinoma, Transitional Cell

Transitional Cell Carcinoma

Avelumab

Antineoplastic Agents, Immunological

Patients with LA/mUC who following 4-6 cycles of platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight intravenously administered over 60 minutes every 2 weeks

Patients with LA/mUC who following 4-6 cycles platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight, intravenously administered over 60 minutes every 2 weeks

Avelumab first-line maintenance

Pfizer CT.gov Call Center

The purpose of this study is to learn about the safety and effects of the study medicine (called avelumab) for the treatment of advanced bladder cancer.

This study is including participants who:

* Participated in the Canadian avelumab patient support program
* Have been diagnosed with advanced bladder cancer
* Have been treated with platinum-based chemotherapy without their disease progressing All participants in this study have previously received avelumab first-line maintenance for the treatment of their advanced bladder cancer.

Pfizer will examine the experiences of people receiving the study medicine. This will help determine the efficacy and safety of the study medicine for the treatment of bladder cancer.

Avelumab was approved by Health Canada in December 2020 for the maintenance treatment of patients with locally advanced/metastatic urothelial carcinoma (LA/mUC) whose disease has not progressed following first-line (1L) platinum-based chemotherapy. As the urothelial carcinoma treatment landscape evolves with novel indications for previously existing medicines and novel agents entering the market, additional insights are needed to assist in guiding treatment decision making. No observational studies of treatment patterns and outcomes for patients in Canada treated with avelumab first-line maintenance (1LM) have been conducted. The purpose of the current study is to conduct an analysis of patient and disease characteristics and treatment patterns to further elucidate the clinical effectiveness and impact of avelumab 1LM therapy for patients with LA/mUC in Canada.

The primary research objective is to assess effectiveness outcomes in a clinical setting for Canadian patients with LA/mUC treated with avelumab 1LM therapy, specifically overall survival (OS) from the date of avelumab 1LM initiation to the date of death from any cause and progression-free survival (PFS) from the date of avelumab 1LM initiation to the date of progression or death from any cause. Selected secondary objectives include describing treatment patterns, describe AEs explicitly attributed to avelumab among patients with LA/mUC treated with avelumab 1LM and response rates from date of avelumab 1LM initiation, and separately, from the date of chemotherapy initiation, and duration of response (DOR) from date of best overall response in each line of therapy.

A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer

Treatment Effectiveness of Avelumab First-Line Maintenance Among Canadian Patients With Advanced Urothelial Carcinoma (TRAVELER)

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

OS from the date of avelumab initiation to the date of death from any cause

Progression-free survival from the date of avelumab first-line maintenance initiation to the date of progression or death from any cause

Description of AEs explicitly attributed to avelumab among patients with LA/mUC treated with AVE 1LM

Response rate from date of AVE 1LM initiation, and separately, from the date of chemotherapy initiation, and DOR from date of best overall response in each line of therapy

OS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of death from any cause

PFS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of progression or death from any cause

First-line therapy type, dose, number of cycles, switching and discontinuations

Time to initiation of AVE 1LM following last dose of chemotherapy

Pfizer

BIRC5 protein, human

William J Allard, PhD

Jose G Moreno, MD

The purpose of this clinical trial is to evaluate the ability of urinary Survivin mRNA measurement to estimate the risk of bladder cancer at the time of cystoscopy in subjects with no prior history of bladder cancer presenting with microscopic or macroscopic hematuria.

Bladder cancer is the fourth most common cancer in men and ninth most common cancer in women, accounting for more than 60,000 new cases and \~12,000 deaths in North America in 2004. Cystoscopy and urinary cytology is the standard of care for detection of bladder cancer, but cystoscopy is expensive and invasive, while cytology has low sensitivity. New, noninvasive, diagnostic tools for bladder cancer detection have been developed, but their application in clinical practice has been limited due to low sensitivity and specificity of the assays. Survivin, an anti-apoptotic protein, is capable of regulating both cell proliferation and apoptotic cell death, and is over-expressed in most human cancers but not in normal adult tissues. The purpose of this clinical trial is to evaluate the ability of urinary Survivin mRNA measurement to estimate the risk of bladder cancer at the time of cystoscopy in subjects with no prior history of bladder cancer presenting with microscopic or macroscopic hematuria.

This study is designed to be a prospective, multicenter, double blind, clinical study in subjects \>50 years old with no prior history of bladder cancer and confirmed hematuria (microscopic and/or macroscopic) presenting to a urologist.

The primary objective of the study is to estimate the risk of bladder cancer at the time of cystoscopy in subjects \>50 years old with no prior history of bladder cancer and confirmed hematuria using urinary Survivin mRNA levels.

The secondary objective of the study is for comparison of a multivariate predictive algorithm using urinary Survivin mRNA levels and subject risk factors, such as age, sex, race, and smoking history, for estimation of the risk of bladder cancer at the time of cystoscopy in subjects \>50 years old with no prior history of bladder cancer and confirmed hematuria to the use of urinary Survivin mRNA levels alone.

Survivin Urine mRNA Assay Risk of Bladder Cancer Study

Evaluation of the Survivin Urine mRNA Assay to Estimate Risk of Bladder Cancer Found on Cystoscopy

Fujirebio Diagnostics, Inc.

Jeff Allard, PhD

Pembrolizumab

Immune Checkpoint Inhibitors

All participants will receive pembrolizumab monotherapy per 21 days no longer than 17 cycles until disease progression or death.

Shang-Bin Qin, MD

Zhi-Song He, MD

Xian-Shu Gao, MD PhD

Wei Yu, MD

This is a Phase II, single-arm, study of pembrolizumab as maintenance therapy in muscle-invasive bladder cancer (MIBC) participants who have received maximum TURBT and tri-modality treatment (TMT) and achieved CR. All participants will receive pembrolizumab monotherapy per 21 days no longer than 17 cycles until disease progression or death.

Radical cystectomy (RC) has long been the standard of care for the treatment of muscle-invasive bladder cancer (MIBC). Modern RC series have demonstrated 5-yr overall survival (OS) rates of 56-66%. There has been an increasing trend of utilizing organ-preserving therapies in the management of bladder cancer over the past several decades. A multidisciplinary approach has led to the development of bladder-sparing approaches using maximal transurethral resection (TURBT) followed by radiotherapy with concomitant radio-sensitizing chemotherapy for MIBC. Multiple tri-modality treatment (TMT) series have suggested that TMT can yield favorable results in well-selected patients. The 5-yr OS is 48-75%, and 75-80% of the survivors have preserved their native bladder. Even if local recurrence occurred after concurrent radio-chemotherapy, salvage cystectomy can also bring 50-57.6% of 5-year disease-specific survival (DSS) without more complications associated with surgery. So, NCCN guidelines have regarded this TMT strategy as a preferred choice for patients with MIBC since 2019.

However, distant metastasis after TMT was still the main concern. Giacalone NJ, et al. reported that the 5-yr distant metastasis rate was 32% in MIBC patients who received an organ-preserving strategy. Up to now, there was no consensus on adjuvant therapy after concurrent radio-chemotherapy. Some retrospective studies demonstrated that adjuvant chemotherapy had no survival benefit, and only approximately 50% of patients completed the planned adjuvant chemotherapy due to intolerable toxicities.

These years, studies on PD-(L)1 inhibitors for urothelial carcinoma showed the efficacy and safety. FDA has approved indications of pembrolizumab used as 1L (selected patients) and 2L treatment for metastatic urothelial carcinoma. Checkmate-274 has reported that adjuvant immunotherapy improved disease-free survival (DFS) in MIBC patients after RC. Javelin Bladder 100 prolonged OS of mUC patients by Avelumab as maintenance therapy who achieved CR, PR or PD after 1L chemotherapy. These results support our hypothesis that, for those MIBC patients who have received bladder-preserving TMT and achieved CR, pembrolizumab monotherapy as maintenance therapy is superior to observation.

Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer

A Pilot Study of Pembrolizumab Monotherapy as Maintenance Therapy in MIBC Patients Who Received Bladder-Preserving Trimodally Therapy and Achieved CR

PFS is defined as the time from first dose of pembrolizumab to any of the following events: recurrent MIBC, nodal or distant metastases or death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.	NCT03335059	Bladder Cancer Bladder Neoplas... Bladder Tumors Cancer of Bladd... Cancer of the B... Malignant Tumor... Neoplasms, Blad... Urinary Bladder... Carcinoma in Si... Papillary Carci... BCG-Unresponsiv...	Synergo® RITE +...	18 Years -	Medical Enterprises Ltd.
Study of ESG401 in Adults With Solid Tumors	NCT04892342	Neoplasms, Brea... Neoplasms, Lung Neoplasms,Color... Neoplasms, Blad... Neoplasm of Sto... Neoplasms,Ovari...	ESG401	18 Years - 75 Years	Shanghai Escugen Biotechnology Co., Ltd
A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer	NCT05699135	Urinary Bladder... Bladder Cancer Bladder Tumors Urothelial Carc...	Avelumab first-...	18 Years -	Pfizer
A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer	NCT05699135	Urinary Bladder... Bladder Cancer Bladder Tumors Urothelial Carc...	Avelumab first-...	18 Years -	Pfizer
Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.	NCT03335059	Bladder Cancer Bladder Neoplas... Bladder Tumors Cancer of Bladd... Cancer of the B... Malignant Tumor... Neoplasms, Blad... Urinary Bladder... Carcinoma in Si... Papillary Carci... BCG-Unresponsiv...	Synergo® RITE +...	18 Years -	Medical Enterprises Ltd.
Survivin Urine mRNA Assay Risk of Bladder Cancer Study	NCT00315653	Bladder Cancer		50 Years -	Fujirebio Diagnostics, Inc.
Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer	NCT05072600	Bladder Cancer Bladder Neoplas... Bladder Tumors Urinary Bladder... Neoplasms, Blad...	Pembrolizumab	18 Years -	Peking University First Hospital

Spots Global Cancer Trial Database for neoplasms, bladder