Study of 2141-V11 for Non-Muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
This study is testing a new treatment called 2141-V11 for people with non-muscle invasive bladder cancer (NMIBC) that hasn't responded to standard treatments. You might be able to join if you have high-grade NMIBC (Ta, CIS, and/or T1) of urothelial histology that didn't respond to BCG therapy. Researchers want to find the safest dose of 2141-V11 and understand how your body handles it. This is one of the first studies to test 2141-V11 in people, and the first to deliver it directly into the bladder. The study aims to enroll 55 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is designed to test the safety of 2141-V11 in different ways.
- What's involved
- Participants will receive 2141-V11 either weekly for 3 weeks, or every 3 weeks for 4 doses, or as a single dose. The study involves evaluations at specific time points, such as weeks 13, 14, 25, and 26.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Cohort A will be followed for up to 2 years, and participants in Cohort B will be followed for up to 1 year after 2141-V11 administration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05126472
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
Recruiting
PHASE1Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~115 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:anti-CD40 antibody 2141-V11Intravesical GemcitabineIntravesical Gemcitabine with anti-CD40 antibody 2141-V11
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MTD/RP2D (Cohort A)
Measured over 2 years
+3 more outcomes measured
Conditions
NCT05126472
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jerseystudy coordinator listed
Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jerseystudy coordinator listed
Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New Yorkstudy coordinator listed
Recruiting
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New Yorkstudy coordinator listed
Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jerseystudy coordinator listed
Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New Yorkstudy coordinator listed
Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Bernard Bochner, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Eligibility criteria
Inclusion
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
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
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 subjects with papillary tumors (Ta and T1), a complete TURBT must have been performed.
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
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:
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.
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.
Subjects with BCG-naïve High-grade Ta NMIBC are eligible. BCG-naïve NMIBC is defined as patients with no prior BCG exposure or no BCG treatment within 2 years of trial start.
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
A complete TURBT must have been performed, as characterized by:
Most recent cystoscopy/TURBT must have been performed within 60 days of the first dose of trial treatment
Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy)
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:
Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment.
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
Willing and able to provide written informed consent/assent for the trial
Able to comply with the treatment schedule as determined by the participant and the licensed practitioner
Exclusion
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
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.
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
What this trial measures
- MTD/RP2D (Cohort A)2 years
The MTD will be defined as the dose level at which the estimated DLT rate from the MCRM model is closest to the target acceptable rate of 20%. If an MTD is not found after the full dose escalation study has been completed, the next dose recommended by the MCRM algorithm will be considered the RP2D. A DLT will be defined as the occurrence of any clinically significant grade 3 or 4 AE (per CTCAE version 5.0) within the DLT evaluation period that is considered by the Principal Investigator or designee to be possibly, probably, or definitely related to 2141-V11.
- Reported number of adverse events from baseline (start of 2141-V11 administration) up until the last follow-up visit after 2141-V11 administration (Cohort B)1 year
AE severity should be graded using CTCAE version 5.0.
- recurrence-free survival (RFS) Cohort B Part 22 years
- Progression of disease2 years
in all subjects will be defined as development of metastatic disease or death following radical cystectomy