Biomarkers in Urothelial Cancer Patients Treated With Pembrolizumab

Status Active, not recruiting

Clinical Trial Summary

In the RESPONDER study, the role of the immune evasive mechanisms combined with genomic characterization will be explored in urothelial cancer patients treated with second-line treatment with pembrolizumab. Combined profiling of immune and molecular status is novel and may contribute to improved patient stratification and provide rationale for future treatment strategies containing pembrolizumab.

Clinical Trial Description

Antibodies that target the crosstalk between immune and cancer cells by inhibiting programmed death 1 (PD-1, Pembrolizumab and Durvalumab) or programmed death-ligand 1 (PD-L1, Atezolizumab) have shown promising results as second-line treatments in phase II studies with response rates of about 30%. Although urothelial cancer is prone to immune checkpoint blockade, better understanding of the underlying mechanisms is necessary to improve patient selection. The efficacy of immune checkpoint inhibitors in urothelial cancer may be affected by both tumor specific and environmental factors. In order to improve the efficacy of immunotherapy in urothelial cancer, drivers of local immune suppression need to be identified. In this prospective translational multicenter study, clinical data, peripheral blood and sequential tumor biopsies are collected from urothelial cancer patients treated with second-line treatment with pembrolizumab to identify the role of immune evasive mechanisms combined with genomic characterization. A pre-treatment tumor biopsy and blood sample will be obtained and subsequently whole genome sequencing and whole genome RNA sequencing is performed. Both tumor tissue as well as peripheral blood will be investigated for immune and molecular profiling. A biopsy will also be taken after start of treatment (at 6 weeks) and at progression (optional) For future research projects, longitudinal blood samples will be collected for isolation of immune cells, cytokine/chemo-attractants and circulating tumor DNA (ctDNA). ;

Study Design

Related Conditions & MeSH terms

Biomarkers
Carcinoma, Transitional Cell
Transitional Cell Carcinoma of the Bladder
Urinary Bladder Neoplasms

Clinical Trial Details

NCT number	NCT03263039
Study type	Interventional
Source	Erasmus Medical Center
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	August 21, 2017
Completion date	August 19, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05095324` - The Biomarker Prediction Model of Septic Risk in Infected Patients
Recruiting	`NCT05548933` - Effects of Non-surgical Periodontal Therapy on Severe Periodontitis and Hyperlipidemia
Active, not recruiting	`NCT03926572` - Acute Decompensation of Pulmonary Hypertension	N/A
Recruiting	`NCT05372159` - Vanderbilt Memory and Aging Project
Completed	`NCT03173586` - Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women	N/A
Completed	`NCT04554628` - Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU	N/A
Terminated	`NCT03250312` - The Effects of OMT on the Expression Patterns of Immune Cell Biomarkers	N/A
Recruiting	`NCT04666766` - Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers	N/A
Completed	`NCT04573543` - The Role of Immune Semaphorins in NAFLD
Completed	`NCT03193671` - Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis	N/A
Recruiting	`NCT06047132` - PREDICTIVE ABILITY OF A PANEL OF BIOMARKERS IN SALIVA IN HEALTHY AND PERIODONTALLY AFFECTED SUBJECTS
Completed	`NCT05361460` - Patients Experiences of Early Postoperative Cognition
Recruiting	`NCT05706194` - Early Neuroprognostication After OHCA
Recruiting	`NCT05138731` - Metabolomics Profiling of Coronary Heart Disease
Not yet recruiting	`NCT04563000` - Impact of Vitamin C on Biomarkers of Neurologic Injury in Survivors of Cardiac Arrest	Phase 2
Completed	`NCT05138692` - Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury
Completed	`NCT02247999` - Improving Cervical Cancer Screening Among HIV-Infected Women in India
Active, not recruiting	`NCT02732301` - Postoperative Gastrointestinal Dysfunction After Cardiac Surgery - Occurrence and Search for Biomarkers
Not yet recruiting	`NCT03269019` - Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia	N/A
Recruiting	`NCT04062279` - Predictors of Parkinson's Disease Progression

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Biomarkers in Urothelial Cancer Patients Treated With Pembrolizumab — RESPONDER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms