Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

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

Transitional Cell Carcinoma

Crouzon Syndrome

Jackson-Weiss Syndrome

Pfeiffer Syndrome

BALVERSA® is a prescription medicine used to treat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery

Balversa

Daniel J. George, MD

Bladder cancers are associated with genetic mutations that are present in the patient's bladder or urothelium, the lining of the lower urinary tract. Fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer.

This study will collect biomarker data from subjects receiving erdafitinib to further investigate the relationship between treatment with erdafitinib and clinical response, progression, and/or genetic alterations.

The purpose of this study is to collect biomarker data from subjects receiving standard of care erdafitinib to further investigate the relationship between treatment with erdafitinib and clinical response, progression, and/or genetic alterations in cell free tumor DNA (cfDNA) from blood and urine samples.

In this study, next generation sequencing of cfDNA isolated from blood and urine will be performed by Resolution Bioscience. Blood-based cfDNA amplification and analysis is done by a CLIA-approved assay and the results of which will thus be available to physicians and patients. Urine-based cfDNA analysis from Resolution Bioscience is not yet approved and results will only be communicated if an actionable finding is identified that is not present on the blood-based test. Samples will be collected at the patients homes by a qualified phlebotomist.

xCures may provide the treating physician and the subject the biomarker results from blood-based cfDNA tests. Because the testing of urine DNA is experimental and done solely for research, those results will not be shared unless there is an important finding known to be relevant to the subject's medical care at the time of the study. The genetic tests are not approved for bladder cancer, so the information generated from biomarker research studies is preliminary in nature. Therefore, the significance and scientific validity of the results are undetermined. xCures and/or Tyra may additionally share data with the treating physician and researchers for the purposes of publication.

Patients co-enroll in an observational research study (XCELSIOR, NCT03793088) and consent to provide xCures right of access to their full medical records under HIPAA.

Patient clinical data is structured and centralized by xCures in a 21 CFR Part 11-compliant REDCap Cloud database in Case Report Forms (CRFs). The CRFs are a set of electronic forms for each patient that provides a record of clinical data generated according to the protocol. Data is abstracted directly from medical records generated in the standard practice of medicine.

xCures will request medical records directly from treating institutions and from other providers (commercial next generation sequencing providers, for example) and will work with treating physicians to ensure the completeness and accuracy of CRF content based on electronic medical records.

Liquid biopsies (blood and urine) will be collected at two or three timepoints per each patient approximately within a 2 to 15 month timeframe.

3 x 10 mL ctDNA whole blood collection

1 x 5 mL Random Urine collection

DNA from blood plasma and urine will be isolated and tumor DNA will be purified.

Samples will be stored securely and may be kept for up to 5 years after the last subject completes the study

Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib

Specimen collection will be performed at the following timepoints to assess clinical response while being treated with erdafitinib:

1. Baseline (prior to or within 7 days of starting erdafitinib)
2. Suspicion of progression (optional)
3. Post-progression

xCures

Digestive System Diseases

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Oxaliplatin

Capecitabine

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks

capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle

Ilya Tsimafeyeu

Magnolia Rouge

The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.

On April 16, 2021, the Food and Drug Administration approved first-line therapy with nivolumab and fluoropyrimidine-platinum-containing chemotherapy for metastatic gastric adenocarcinoma. Patients with PD-L1 expression benefit the most from this treatment.

Fibroblast growth factor receptor 2 (FGFR2) is a predictor of poor overall survival and a potential target for targeted therapy. However, there is no data of nivolumab efficacy in patients with combined expression of PD-L1 and FGFR2.

The aim of this study is to evaluate the preliminary efficacy of nivolumab in this patient population.

Nivolumab in combination with chemotherapy

Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer

Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study

Proportion of patients who will be progression-free at 1 year

From first day of treatment to the first observation of disease progression or death due to any cause

From first day of treatment to time of death due to any cause.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 3 and above adverse events possibly, probably or definitely related to treatment.

Kidney Cancer Research Bureau

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Fulvestrant

Mitogens

Futibatinib

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Group/Cohort 1 Description HR+ HER2- Measurable Disease w/ FGFR2 Amplification

Group/Cohort 2 Description TNBC Measurable Disease w/ FGFR2 Amplification

Group/Cohort 3 Description HR+ HER2- or TNBC Non-Measurable Disease w/ FGFR2 Amplification

Group/Cohort 4 Description HR+ HER2- Measurable Disease w/ FGFR1 Amplification

Futibatinib 20mg once daily on a 28 day cycle

Futibatinib 20mg once daily and 500 mg fulvestrant administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on a 28-day cycle.

Futibatinib plus Fulvestrant

The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects.

This is a Phase 2, open-label, non-randomized, multicenter study designed to evaluate the efficacy and safety of futibatinib (TAS-120) and futibatinib + fulvestrant in up to 168 adult patients with locally advanced/metastatic breast cancer harboring FGFR gene amplifications. Patients will be enrolled to 1 of 4 treatment cohorts based on diagnosis and FGFR gene amplification status, and will receive either single agent futibatinib in Cohorts 1-3 or futibatinib plus fulvestrant in Cohort 4, as follows:

* Cohort 1 - HR+ HER2- Measurable Disease w/ FGFR2 Amplification
* Cohort 2 - TNBC Measurable Disease w/ FGFR2 Amplification
* Cohort 3 - HR+ HER2- or TNBC Non-Measurable Disease w/ FGFR2 Amplification
* Cohort 4 - HR+ HER2- Measurable Disease w/ FGFR1 Amplification

A Study of TAS-120 in Patients With Metastatic Breast Cancer

A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications

Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors

CBR is defined as the proportion of patients with a confirmed response of CR or SD lasting at least 24 weeks

The 6-month PFS rate is defined as the proportion of patients who are alive and progression-free 6 months after the first dose of study therapy

CR is defined as the disappearance of all target and/or non-target lesions

CBR is defined as the proportion of patient with a confirmed response of CR, PR or SD lasting at least 24 weeks

6-month PFS rate is defined as the proportion of patients who are alive and progression-free 6 months after the first dose of study therapy

PFS is defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression

DOR is defined as the time from first documentation of objective response to the date of death (any cause) or disease progression

OS is defined as the time (in months) from the first dose of study therapy to the date of death (any cause)

Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed

Standard safety monitoring and grading of treatment-emergent adverse events (AEs) will be performed using Common Terminology Criteria for Adverse Events (CTCAE - Version 5).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib	NCT05052372	Bladder Cancer Urothelial Carc... Transitional Ce... Platinum-Resist... Bladder Urothel... FGFR Mutation FGFR2 Gene Muta... FGFR3 Gene Muta... FGFR2 Amplifica... Locally Advance... Metastatic Urot... Refractory Blad... Refractory Blad...	Balversa	18 Years -	xCures
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib	NCT05052372	Bladder Cancer Urothelial Carc... Transitional Ce... Platinum-Resist... Bladder Urothel... FGFR Mutation FGFR2 Gene Muta... FGFR3 Gene Muta... FGFR2 Amplifica... Locally Advance... Metastatic Urot... Refractory Blad... Refractory Blad...	Balversa	18 Years -	xCures
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer	NCT05859477	Metastatic Gast... PD-L1 Gene Ampl... FGFR2 Amplifica...	Nivolumab Capecitabine Oxaliplatin	18 Years -	Kidney Cancer Research Bureau
A Study of TAS-120 in Patients With Metastatic Breast Cancer	NCT04024436	Metastatic Brea... FGFR 1 High Amp... FGFR2 Amplifica...	Futibatinib Futibatinib plu...	18 Years -	Taiho Oncology, Inc.
A Study of TAS-120 in Patients With Metastatic Breast Cancer	NCT04024436	Metastatic Brea... FGFR 1 High Amp... FGFR2 Amplifica...	Futibatinib Futibatinib plu...	18 Years -	Taiho Oncology, Inc.

Spots Global Cancer Trial Database for fgfr2 amplification