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New treatment option for Non-muscle Invasive Bladder Cancer
Official title Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
ClinicalTrials.gov ID: NCT05126472
What this study is testing
What is anti-CD40 antibody 2141-V11?
anti-CD40 antibody 2141-V11 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for non-muscle invasive bladder cancer.
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
- 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.
- Phase 1: an early, usually small safety study
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
- 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
- people with tumors of mixed urothelial/non-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; people...
- In those people with CIS, the CIS must be present on the tumor sample from the most recent cystoscopy/TURBT
You likely can't join if
- (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: people on topical therapy (e.g. topical 5-
- Cohort C Exceptions: people on topical therapy (e.g. topical 5-fluorouracil) and Neoadjuvant chemotherapy (e.g. cisplatin and gemcitabine)
See the full eligibility criteria
Who can join
- 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
- people with tumors of mixed urothelial/non-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; people with predominant or exclusively non-urothelial histology are excluded
- In those people 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
- people with tumors of mixed urothelial/non-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; people with predominant or exclusively non-urothelial histology are excluded...
- In people 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...
- 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 people of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment.
- Female people 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...
- 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 people 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...
- 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...
- Male people 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.
What rules you out
- (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: people on topical therapy (e.g. topical 5-
- Cohort C Exceptions: people 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...
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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; people with past/resolved Hepatitis B Virus (HBV) infection (defined as having a negative HBsAg and a positive...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 - 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?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.