Is NCT05126472 recruiting in Uniondale, NY?

Yes, NCT05126472 is currently recruiting participants at its Uniondale, NY location. This non-muscle invasive bladder cancer clinical trial is actively enrolling qualified participants.

Is participation in this Uniondale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Non-muscle Invasive Bladder Cancer Clinical Trial in Uniondale, NY

Q: How do I join the non-muscle invasive bladder cancer clinical trial in Uniondale?

To join this clinical trial in Uniondale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Non-muscle Invasive Bladder Cancer Study in Uniondale

The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder. The researchers will test different doses of 2141-V11 to see which dose is safest in people. The researchers will also do tests to see how the body absorbs, distributes, and gets rid of 2141-V11. This study is one of the first to test 2141-V11 in people, and the first to test 2141-V11 delivered through a catheter into the bladder.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Cohorts A and B

High-grade (HG) NMIBC (HG Ta, CIS, and/or T1) of urothelial histology that is unresponsive to adequate BCG therapy.

Stage, grade, and histology must be confirmed by the MSK Department of Pathology

Subjects with tumors of mixed urothelial/non-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded

In those subjects with CIS, the CIS must be present on the tumor sample from the most recent cystoscopy/TURBT

In this context, adequate BCG therapy is defined as at least one of the following:

At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy

At least five of six doses of an initial induction course plus at least two of six doses of a second induction course

Disease unresponsive to adequate BCG therapy is defined as the following. Suspected recurrence from suspicious cytology or cystoscopy, and later confirmed via TURBT, is acceptable:

Persistent or recurrent CIS alone or with recurrent Ta/T1 disease (noninvasive papillary disease/tumor invades the subepithelial connective tissue) within 12 months of completion of adequate BCG therapy

Recurrent HG Ta/T1 disease within 6 months of completion of adequate BCG therapy

HG T1 disease at the first evaluation following an induction BCG course Cohort C:

Muslce invasive bladder cancer cT2-T4aN0-2 that has a predominant urothelial histology.

Stage, grade, and histology must be confirmed by the MSK Department of Pathology

In subjects with papillary tumors (Ta and T1), a complete TURBT must have been performed. This is characterized by:

Attainment of a visually complete resection of all papillary tumors (Ta and T1)

Residual CIS not amenable to complete transurethral resection is acceptable

Receipt of restaging transurethral resection for any tumor with invasion into the lamina propria (HG T1) as part of standard care, with documented presence of uninvolved detrusor muscle.

Most recent cystoscopy/TURBT must have been performed within 6 months of the first dose of trial treatment.

Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy).

Have elected not to undergo or are considered ineligible for radical cystectomy, as determined by the treating surgeon. Reasons for ineligibility or refusal of radical cystectomy should be discussed with the subject as part of the informed consent process.

Ineligibility factors for radical cystectomy may include, but are not limited to:

Cardiovascular disease (e.g., recent acute coronary syndrome, arrhythmia, heart failure)

Chronic obstructive pulmonary disease that would preclude a safe surgical procedure, as determined by the treating surgeon

Poor performance status

Prior major abdominal and pelvic surgery that would preclude a safe surgical procedure, as determined by the treating surgeon Cohort C Only:

Are willing to undergo a standard of care examination under anesthesia or cystoscopy within four weeks of scheduled radical cystetomy.

Patients must have received 3-4 cycles of neoadjuvant Enfortumab Vedotin and pembrolizumab

Age ≥18 years on day of signing informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status ≤2 / Karnofsky performance status ≥60%, as assessed within 28 days prior to treatment initiation.

Required values for screening laboratory tests, performed within 28 days prior to treatment initiation: Absolute neutrophil count (ANC) ≥1000/mm3

Platelets \>75,000/mm3 without

Hemoglobin \>8 g/dL

Creatinine clearance \>40 mL/min for the dose-escalation phases, \>25 mL/min for the dose expansion phases (estimated GFR can also be used in place of creatinine clearance)

AST/ALT ≤3 times the institutional upper limit of normal (ULN)

Total bilirubin ≤1.5 times the institutional ULN

Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment.

Female subjects will be considered of non-reproductive potential if any of the following:

Postmenopausal \[defined as at least 12 months with no menses without an alternative medical cause; in women \<45 years of age a high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening

Has a congenital or acquired condition that prevents childbearing

Male and female subjects of childbearing potential must agree, if participating in sexual activity that could lead to pregnancy, to use of an adequate method of contraception from the day of study medication initiation (or 14 days prior to the initiation of study medication for oral contraception) throughout the study period up to 120 days after the last dose of trial therapy. Subjects should be informed that taking the study medication(s) may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study. Male subjects will be considered of non-reproductive potential if they have azoospermia (whether due to vasectomy or an underlying medical condition). Female subjects will be considered of non-reproductive potential if as described above. Acceptable methods of contraception:

Single method (one of the following is acceptable): intrauterine device, vasectomy of a female subject's male partner, or contraceptive rod implanted into the skin

Combination method (requires use of two of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), or hormonal contraceptive \[oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection

Male subjects must agree not to donate sperm during and after the study

Able to comply with the treatment schedule as determined by the participant and the licensed practitioner.

Exclusion Criteria

(Cohort A and B)

History of or currently being treated for muscle-invasive (T2, T3, T4) locally-advanced non-resectable or metastatic urothelial carcinoma.

Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma.

Concurrent anti-cancer therapy, including investigational agents Exceptions include:

Cohorts A and B Exceptions: Subjects on topical therapy (e.g. topical 5-

Cohort C Exceptions: Subjects on topical therapy (e.g. topical 5-fluorouracil) and Neoadjuvant chemotherapy (e.g. cisplatin and gemcitabine)

Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment (a single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local/regional practices, is acceptable).

Have received any other neoadjuvant treatment other than Enfortumab Vedotin and pembrolizumab for muscle invasive bladder cancer

Has had prior chemotherapy, targeted small molecule therapy, cytokine therapy, or radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent. °Subjects with Grade ≤2 neuropathy or Grade ≤2 alopecia are an exception to this criterion and may qualify for the study

Major surgery or a wound that has not fully healed within 4 weeks prior to the first dose of trial treatment. ° If subject has undergone major surgery greater than 4 weeks prior, subject must have recovered adequately from the toxicity and/or complications from the intervention prior to starting trial therapy

Known additional malignancy that has had progression or has required active treatment in the last three years Exceptions include:

Basal cell carcinoma of the skin

Squamous cell carcinoma of the skin that has undergone potentially curative therapy

In situ cervical cancer

History of prostate cancer treated with definitive intent (surgical or radiation therapy), provided that the following criteria are met: stage T2N0M0 or lower with a Gleason score ≤7 and prostate-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy, that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study enrollment

Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Diagnosis of immunodeficiency, concurrent immune suppressive disease, or is receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 4 weeks prior to the planned first dose of trial treatment. The use of physiologic doses of corticosteroids as replacement therapy (for adrenal or pituitary insufficiency, etc.) is acceptable. Topical and inhaled corticosteroids in standard doses are acceptable.

Known contraindications to intravesical therapy:

Febrile illness, symptomatic urinary tract infection, or persistent gross hematuria

Traumatic catheterization or gross hematuria on day of treatment

Active infection requiring systemic therapy, including active or intractable urinary tract infection within 4 weeks prior to the first dose of trial treatment

Severe infection within 4 weeks prior to the first dose of trial treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.

History of (non-infectious) pneumonitis that required steroids or current pneumonitis.

History of Human Immunodeficiency Virus (HIV) infection (e.g., positive HIV-1/2 antibodies).

Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C \[e.g., HCV RNA (qualitative) detected\] infection; subjects with past/resolved Hepatitis B Virus (HBV) infection (defined as having a negative HBsAg and a positive antibody to Hepatitis B core antigen) or Hepatitis C Virus (HCV) infection are eligible only if polymerase chain reaction (PCR) testing is negative for HBV DNA or HCV RNA, respectively (must be obtained within 28 days prior to treatment initiation).

Pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment

History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

History of pulmonary embolism or any other thromboembolic event within 6 months prior to enrollment.

History of undergoing an allogeneic tissue/solid organ transplant

History or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the subject's participation for the full duration of the trial, interfere with the subject's ability to cooperate with the requirements of the trial, confound the results of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Uniondale?

Yes, this clinical trial (NCT05126472) has an active research site in Uniondale, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Non-muscle Invasive Bladder Cancer Treatment Options in Uniondale, NY

If you're searching for non-muscle invasive bladder cancer treatment options in Uniondale, NY, this clinical trial (NCT05126472) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Uniondale research site is actively enrolling participants for this clinical trial. You'll receive care from experienced non-muscle invasive bladder cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all non-muscle invasive bladder cancer clinical trials near you to find additional studies recruiting in your area.

Non-muscle Invasive Bladder Cancer Clinical Trial in Uniondale, NY

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