Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

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

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Immunomodulating Agents

Nivolumab

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.

Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.

Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.

Badrinath Konety, MD, MBA

Shilpa Gupta, MD

This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin (GC) every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical cystectomy.

BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy

BLASST-1 (Bladder Cancer Signal Seeking Trial): Phase II Trial of Neoadjuvant Nivolumab With Cisplatin and Gemcitabine in Muscle-Invasive Bladder Cancer (MIBC) Patients Undergoing Radical Cystectomy

Incidence of Measurable Disease "pT" in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a "flat tumor" stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.

Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin

Count of participants experiencing Progression Free Survival (PFS)

Bristol-Myers Squibb

Masonic Cancer Center, University of Minnesota

Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.

Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.

Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.

Nivolumab, Cisplatin, & Gemcitabine

Age, Categorical

Male

Female

Unknown

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Konety Badrinath

Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)

Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)

Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)

Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)

Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)

Safety of Nivolumab With Gemcitabine/Cisplatin

Count of Participants Experiencing Progression Free Survival (PFS)

Overall Study

Symptoms and General Pathology

Infections

Digestive System Diseases

Ulcer

Communicable Diseases

Crohn Disease

Colitis

Colitis, Ulcerative

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Gastrointestinal Agents

Anti-Inflammatory Agents

Analgesics

Methotrexate

Ustekinumab

Tofacitinib

Ozanimod

Vedolizumab

Upadacitinib

Adalimumab

Janus Kinase Inhibitors

Infliximab

Golimumab

Interleukin-12

Interleukin-23

Mirikizumab

Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab)

Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib)

Patient treated with S1P modulators (ozanimod, etrasimod)

Patient treated with anti-TNF (infliximab, adalimumab, golimumab) (with a maximal proportion of 25% as 1st first line biologic after conventional treatment (aminosalicylates, corticosteroids, thiopurines, methotrexate))

Patient treated with anti-integrins (vedolizumab)

Patient treated with anti-IL12/23 (ustekinumab)

This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.

Non-interventional

Marie Coisnon

Charlotte Mailhat

Mathurin FUMERY, PHD

Julien Kirchgesner

Mathurin Fumery

This is a French prospective longitudinal observational multicentre cohort study.

Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.

Number of patients : 6 000 at least Participating investigators : 250 at least

Recruitment period : 3 years 6 months

Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.

Secondary objectives :

* To assess the presence and the extent of safety concerns in patients treated with JAKi, anti-IL23p19, and S1p modulators for each outcome of interest separately (cancer, serious infections, arterial thrombotic events, venous thrombotic events)
* To investigate prospectively the impact of JAKi, anti-IL23p19 and S1p modulators strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations
* To assess the evolution of ePROs on a trimester basis and the impact of JAKi, anti-IL23p19, and S1p modulators on ePROs in IBD
* To evaluate the benefit-risk ratio of strategies based on a wider use of JAKi, anti-IL23p19, and S1p modulators therapy for IBD
* To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD.

Ibd CAncer and seRious Infections in France (I-CARE 2)

The primary objective of I-CARE 2 is to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.

The risk of cancers, serious infections and vascular events will be stratified according to IBD phenotype, disease activity (clinical, radiologic and endoscopic) and main comorbidities at baseline.

To assess the presence and the extent of safety concerns in patients treated with JAKi, anti-IL23p19, and S1p modulators for each outcome of interest separately

* Cancer
* Serious infections
* Arterial thrombotic events
* Venous thrombotic events

To investigate prospectively the impact of JAKi, anti-IL23p19 and S1p modulators strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations

To assess the evolution of ePROs on a trimester basis and the impact of JAKi, anti-IL23p19, and S1p modulators on ePROs in IBD

To evaluate the benefit-risk ratio of strategies based on a wider use of JAKi, anti-IL23p19, and S1p modulators therapy for IBD

To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD.

Sanoia

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Skin and Connective Tissue Diseases

Uterine Cervical Neoplasms

Breast Neoplasms

Colorectal Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Rectal Diseases

The usual care group received usual care that varies dependent upon the practice setting.

TIWeb (Tailored Web Intervention) program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.

CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.

TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.

Intervention: TIWeb program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.

TIWeb

Intervention: CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.

Intervention: The usual care group received usual care that varies dependent upon the practice setting.

Intervention: TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.

TIWeb+CSC

Victoria Champion, PhD

This study compares the efficacy (adherence and stage) of four interventions to promote colorectal (CRC) and breast cancer (BC) screenings among women ages 50 to 75. They are:

1. usual care;
2. a TIWeb (tailored intervention Website)
3. a CSC (cancer screening call) and
4. TIWeb + a CSC. This study also compares the cost-effectiveness of the 4 interventions to promote CRC and BC screening among women ages 50 to 75.

This study addresses innovative approaches to increase adherence to screening tests for colorectal and breast cancer - two cancers that have the greatest impact on female cancer mortality in the United States.The cancer burden in women could be significantly reduced by increasing participation in recommended screening for colorectal cancer (CRC) and breast cancer (BC) in all eligible women. This research tests intervention to simultaneously increase both CRC and BC screening using behavior change strategies, and also estimates the efficacy and cost-effectiveness of the interventions. Two groups of women, Group A (adherent to BC screening guidelines, but NOT to CRC screening guidelines) and Group B (non-adherent to BC \& CRC guidelines) are randomized to 1. Usual Care, 2. TIWeb, 3. CSC and 4. TIWeb +CSC.

We propose a prospective randomized 2x2 factorial design: 1)usual care; 2) a TIWeb; 3) a Cancer Screening Call (CSC), and 4 a TIWEB+ a Cancer Screening Call (CSC). The intervention will be tested in 2 groups of women. Group A will include women who are nonadherent to CRC but adherent to BC screening guidelines. Group B will include women who are nonadherent to both CRC and BC screening guidelines.

Increasing Colorectal and Breast Cancer Screening in Women

De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Box Health) that is password protected.

any CRC test (either a stool test or colonoscopy) receipt of a stool test or a colonoscopy

Forward stage movement is the desired outcome -determining any forward stage movement in considering CRC screening either from Precontemplation to contemplation or from precontemplation to action

Comparing the cost-effectiveness of four conditions to promote CRC and BC screening , there will be differences in adherence to both CRC and BC screening and stage of adoption, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.

National Cancer Institute (NCI)

Indiana University

Distinguished Professor Edward and Sara Stam Culliper named Professor Associate Director Cancer Prevention and Control

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Muscle-invasive Urothelial Carcinoma Participants who received nivolumab as adjuvant treatment at least once from March 28, 2022 to December 31, 2023

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain the NCT# and Site #.

The purpose of this study is to evaluate the effectiveness, safety, and actual treatment status of nivolumab administered as an adjuvant treatment for participants with muscle-invasive urothelial carcinoma (MIUC), including bladder, renal pelvis, and ureteral cancer, in a Japanese real-world clinical practice.

A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma

An Observational Study Evaluating Treatment Situations of Adjuvant Nivolumab for Muscle-invasive Urothelial Carcinoma in Japan

The time from the date of nivolumab initiation to the date of first recurrence (urothelial local recurrence, non-urothelial local recurrence, or distant recurrence) or death from any cause as an event, whichever occurs first.

The time from the date of nivolumab initiation to the date of first recurrence (local or distant non-urothelial recurrence) or death from any cause as an event, whichever occurs first.

The time from the start date of nivolumab administration to the last administration date

The treatment completion rate will be calculated\* according to the following formula:

Treatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100

The time from the date of nivolumab initiation to the date of death from any cause

The time from the date of nivolumab initiation to the date of death due to the primary disease

Treatment continuation rate (%)=(Patients continuing treatment at the timepoint)/(All eligible patients)×100

Dose intensity (%)=(Actual dose)/(Total dose planned)×100

The proportion of eligible patients who completed and started treatment after recurrence.

The time from the start date of treatment administration to the last administration date after recurrence.

The time from the start date of nivolumab to the start date of treatment after recurrence.

Measured before NAC, before radical resection, immediately before nivolumab treatment, at the time of recurrence, or at the start of post-recurrence treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy	NCT03294304	Muscle Invasive...	Nivolumab Cisplatin Gemcitabine	18 Years -	Masonic Cancer Center, University of Minnesota
Ibd CAncer and seRious Infections in France (I-CARE 2)	NCT06089590	IBD Ulcerative Coli... Crohn Disease	Non-interventio...	18 Years - 75 Years	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy	NCT03294304	Muscle Invasive...	Nivolumab Cisplatin Gemcitabine	18 Years -	Masonic Cancer Center, University of Minnesota
Increasing Colorectal and Breast Cancer Screening in Women	NCT03279198	Breast Cancer F... Colorectal Canc...	TIWeb CSC UC TIWeb+CSC	50 Years - 75 Years	Indiana University
A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma	NCT05779592	Muscle-invasive...		18 Years -	Bristol-Myers Squibb
BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy	NCT03294304	Muscle Invasive...	Nivolumab Cisplatin Gemcitabine	18 Years -	Masonic Cancer Center, University of Minnesota
Ibd CAncer and seRious Infections in France (I-CARE 2)	NCT06089590	IBD Ulcerative Coli... Crohn Disease	Non-interventio...	18 Years - 75 Years	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy	NCT03294304	Muscle Invasive...	Nivolumab Cisplatin Gemcitabine	18 Years -	Masonic Cancer Center, University of Minnesota
Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)	NCT02393248	Lung Cancer Solid Tumor Gastric Cancer Urothelial Canc... Endometrial Can... Multiple Myelom... Myeloproliferat... Breast Cancer Cholangiocarcin... UC MPN	Pemigatinib Gemcitabine Pembrolizumab Docetaxel Trastuzumab Retifanlimab Cisplatin	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for uc

Every month we try and update this database with for uc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for uc

Every month we try and update this database with for uc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for uc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.