Clinical trial for Bladder Urothelial Carcinoma
Official title Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy
ClinicalTrials.gov ID: NCT06263153
What this study is testing
What is Durvalumab?
This is an investigational medicine being studied as a potential treatment for bladder cancer. It is designed to help the body's immune system recognize and attack tumor cells.
Also referred to as Imfinzi.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether giving futibatinib and durvalumab before surgery helps treat muscle‑invasive bladder cancer in people who cannot receive cisplatin.
- Who it's for
- You may be able to join if you have muscle‑invasive bladder cancer and cannot take cisplatin because of kidney problems, nerve damage, poor health, or heart issues.
- What's involved
- You will take the medicine at home for a short time before your bladder surgery. The team will check you with visits and tests to see how you are doing.
- Time commitment
- The study lasts a few weeks before surgery, with a few clinic visits for medication and safety checks.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to provide signed informed consent
- Female or male people \>= 18 years old
- Bodyweight \>30kg
- FGFR1, 2, or 3 overexpression as defined by a score of 3+ or 4+ on ribonucleic acid (RNA) in-situ hybridization (RNAScope assay)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
You likely can't join if
- Women who are pregnant or breastfeeding
- Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose...
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks before the...
- Has upper tract urothelial carcinoma
- Has small-cell carcinoma component on histology
- Evidence of measurable nodal or metastatic disease
See the full eligibility criteria
Who can join
- Able to provide signed informed consent
- Female or male people \>= 18 years old
- Bodyweight \>30kg
- FGFR1, 2, or 3 overexpression as defined by a score of 3+ or 4+ on ribonucleic acid (RNA) in-situ hybridization (RNAScope assay)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Histologically confirmed urothelial carcinoma of the bladder
- Mixed histologies are permitted if urothelial carcinoma is the predominant histology ( \>= 50%)
- Clinical stage T2-T4a, N0, M0 disease by trans urethral removal of bladder tumour (TURBT) and imaging studies (stage II-IIIA per American Joint Committee on Cancer [AJCC] 2018)
- ECOG performance status (PS) \> 1
- Creatinine clearance (calculated or measured) \< 60 mL/min as measured by the Cockcroft-Gault formula
- Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0) grade \>= 2 hearing loss
- CTCAE v 5.0 grade \>= 2 neuropathy
- New York Heart Association (NYHA) class \> II cardiac dysfunction
- Treatment with anti-PD-1/PD-L1 therapy for non-muscle invasive bladder cancer (NMIBC) is permitted if it is completed \> 3 months before registration
- Fit and planned for radical cystectomy according to local guidelines
- Archival transurethral resection of bladder tumor (TURBT) tissue submission must be 30 unstained slides. If archival tissue is unavailable, the patient must undergo cystoscopy and biopsy.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female premenopausal patients.
- Female people of childbearing potential and male people must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate), from the time of signing...
- Hemoglobin \>= 9.0 g/dL
- Absolute neutrophil count (ANC) \> 1500 per mm\^3
- Platelet count \>= 100 x 10\^9/L
- International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \< 1.5 × upper limit of normal (ULN), unless the patient is receiving anticoagulation therapy provided INR or PTT is within the...
- Bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 x institutional upper limit of normal
- Phosphorus ≤ institutional upper limit of normal (ULN)
- Measured creatinine clearance (CL) ≥ 30 mL/min or calculated creatinine CL ≥ 30 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Must have a life expectancy of at least 12 weeks
What rules you out
- Women who are pregnant or breastfeeding
- Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks before the first dose of trial treatment
- Has upper tract urothelial carcinoma
- Has small-cell carcinoma component on histology
- Evidence of measurable nodal or metastatic disease
- Concurrent anticancer therapy (e.g., chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, intravesical therapy, or tumor embolization)
- Received prior systemic chemotherapy for muscle-invasive bladder cancer at any time in the patient's medical history
- Has received anti-PD-1/PD-L1 therapy or FGFR inhibitor previously for MIBC, except if used in earlier stage urothelial carcinoma such as non-muscle invasive bladder cancer (NMIBC) and completed \> 3 months prior to...
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
- Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.
- Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance...
- Underwent major surgery and has not recovered adequately from the intervention's toxicity and/or complications before starting therapy
- Has an active second malignancy except for low-risk localized prostate cancer on "watch and wait"
- people with a history of malignancy that has been completely treated, with no evidence of active cancer for 2 years before enrollment, or people with surgically cured tumors with a low risk of recurrence are allowed to...
- Myocardial infarction or unstable angina pectoris within 3 months of the first date of study therapy
- Unstable arrhythmias
- Decompensated heart failure
- Uncontrolled hypertension and unstable angina pectoris
- Average QT corrected by the Fridericia formula (QTcF) \> 470 msec (males and females) (Note: If the QTcF is \> 470 msec in the first electrocardiography [ECG], a total of 3 ECGs separated by \>= 5 minutes should be...
- Has any medical condition that may prevent the patient from undergoing radical cystectomy
- Must be at least 2 weeks beyond high-dose systemic corticosteroids; chronic steroid use up to 10 mg daily prednisone (or equivalent), intranasal, inhaled, topical steroids, local steroid injections (e.g., intra...
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Has a known history of HIV-1/2 with detectable viral load and/or CD4 count \< 300/mL within the previous 3 months or active tuberculosis infection (clinical evaluation that may include clinical history, physical...
- Has detectable hepatitis B virus (HBV) or hepatitis C virus (HCV) viral load polymerase chain reaction (PCR) if there is a known history of active hepatitis B or hepatitis C
- History and/or current evidence of significant ectopic mineralization/calcification including but not limited to the soft tissues, kidneys, intestines, myocardium, and lungs, except calcified lymph nodes and...
- Current evidence of corneal or retinal disorder/ keratopathy including but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic...
- Have current evidence of endocrine alterations of calcium/phosphate homeostasis (e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis) unless well controlled
- Have used drugs that are dual p-glycoprotein and strong CYP3A inducers or inhibitors within 7 days prior to the first dose of the study drug
- Has other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of the study procedure and follow-up examinations
- Known allergy or hypersensitivity to study drugs or any excipient.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product (IP).
- Has other uncontrolled illnesses, ongoing or active infection, or serious chronic gastrointestinal conditions associated with diarrhea
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician
- History of allogenic organ transplantation
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States; Columbus, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.