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Female Urogenital Diseases and Pregnancy Complications

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Transitional Cell Carcinoma

Crouzon Syndrome

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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

Urethral Neoplasms

Ureteral Neoplasms

Pelvic Neoplasms

Urethral Diseases

Ureteral Diseases

Urethral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Antibodies

Paclitaxel

Gemcitabine

Sacituzumab govitecan

Docetaxel

Albumin-Bound Paclitaxel

Immunoglobulins

Halichondrin B

Camptothecin

Immunoconjugates

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Patients receive 1 of the 4 standard of care chemotherapy regimens based on treating investigator's choice: Choice A: Patients receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice B: Patients receive gemcitabine IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Choice C: Patients receive paclitaxel IV on days 1, 8, and 15. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice D: Patients receive sacituzumab govitecan IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI and bone scan throughout the trial. Patients also undergo blood and urine sample collection on the trial.

Patients receive eribulin IV over 2-5 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI and bone scan throughout the trial. Patients also undergo blood and urine sample collection on the trial. (CLOSED TO ACCRUAL)

Patients receive eribulin IV over 2-5 minutes and gemcitabine IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI and bone scan throughout the trial. Patients also undergo blood and urine sample collection on the trial.

Undergo blood and urine sample collection

Biospecimen Collection

Bone Scan

Computed Tomography

Eribulin Mesylate

Gemcitabine Hydrochloride

Magnetic Resonance Imaging

Sacituzumab Govitecan

Site Public Contact

John A. Ellerton

Shahzad Siddique

Sarmad Sadeghi

Primo N. Lara

Elizabeth R. Kessler

Christopher M. Reynolds

John M. Schallenkamp

Maha H. Hussain

Prem Sobti

Bryan A. Faller

Ami Badami

Joseph J. Merchant

Joshua Lukenbill

This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.

PRIMARY OBJECTIVES:

I. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin plus gemcitabine hydrochloride (gemcitabine).

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) in the standard treatment arm to the experimental treatment arm in this population.

II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR), both confirmed and unconfirmed, complete and partial responses (CR and PR), in the standard treatment arm to the experimental treatment arm in the subset of participants with measurable disease in this population.

III. To compare duration of response (DOR) in the standard treatment arm to the experimental treatment arm in the subset of participants with measurable disease in this population.

IV. To compare disease control rate (DCR) in the standard treatment arm to the experimental treatment arm in the subset of participants with measurable disease in this population.

BANKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive 1 of the 4 standard of care chemotherapy regimens based on treating investigator's choice: Choice A: Patients receive docetaxel intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice B: Patients receive gemcitabine IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Choice C: Patients receive paclitaxel IV on days 1, 8, and 15. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice D: Patients receive sacituzumab govitecan IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive eribulin IV over 2-5 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL)

ARM III: Patients receive eribulin IV over 2-5 minutes and gemcitabine IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

All patients undergo computed tomography (CT), magnetic resonance imaging (MRI) and bone scan throughout the trial. Patients also undergo blood and urine sample collection on the trial.

After completion of study treatment, patients are followed up every 6 months for 2 years from the date of registration, then every 12 months until death or 3 years from the date of registration

Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer

A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

Percentage of patients achieving at least a stable disease as best response on imaging using RECIST 1.1 criteria during treatment.

National Cancer Institute (NCI)

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
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer	NCT04579224	Metastatic Blad... Metastatic Rena... Metastatic Uret... Metastatic Uret... Metastatic Urot... Refractory Blad... Refractory Rena... Refractory Uret... Refractory Uret... Refractory Urot... Stage IV Bladde... Stage IV Renal ... Stage IV Renal ... Stage IV Ureter... Stage IV Urethr... Stage IVA Bladd... Stage IVB Bladd...	Biospecimen Col... Bone Scan Computed Tomogr... Docetaxel Eribulin Mesyla... Gemcitabine Hyd... Magnetic Resona... Paclitaxel Sacituzumab Gov...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for refractory bladder urothelial carcinoma