Actively Recruiting
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-08
55
Participants Needed
7
Research Sites
312 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
P
Pin Down Bladder Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- High-grade non-muscle invasive bladder cancer (HG Ta, CIS, and/or T1) unresponsive to adequate BCG therapy for Cohorts A and B
- Muscle-invasive bladder cancer cT2-T4aN0-2 with predominant urothelial histology for Cohort C
- Confirmation of stage, grade, and histology by MSK Department of Pathology
- Complete transurethral resection of papillary tumors (Ta and T1) for Cohorts A and B
- Most recent cystoscopy or tumor resection within 6 months before first treatment
- No urothelial carcinoma in the upper urinary tract
- Not undergoing or ineligible for radical cystectomy due to medical or personal reasons
- ECOG performance status of 0 to 2 or Karnofsky performance status ≥60%
- Adequate laboratory values for blood counts and organ function within 28 days prior to treatment
- Female participants of childbearing potential must have negative pregnancy test and agree to contraception
- Male and female participants of childbearing potential must agree to use contraception during and after treatment
- Able to comply with treatment schedule
- For Cohort C, patients must have received 3-4 cycles of neoadjuvant Enfortumab Vedotin and pembrolizumab and be willing to undergo examination before planned cystectomy
You will not qualify if you...
- History or current muscle-invasive, locally advanced, non-resectable, or metastatic urothelial carcinoma for Cohorts A and B
- Evidence of urothelial carcinoma outside the bladder
- Receiving concurrent anti-cancer therapy except allowed topical therapies
- Prior intravesical chemotherapy or immunotherapy after most recent cystoscopy/TURBT except single dose during screening
- Received neoadjuvant treatment other than Enfortumab Vedotin and pembrolizumab for muscle invasive bladder cancer
- Chemotherapy, targeted therapy, cytokine therapy, or radiation within 2 weeks before starting trial or unresolved side effects except mild neuropathy or alopecia
- Major surgery or unhealed wound within 4 weeks before treatment
- Known additional malignancy with progression or treatment in the last 3 years except certain skin and cervical cancers and stable prostate cancer
- Active autoimmune disease requiring systemic treatment in last 2 years
- Immunodeficiency or immunosuppressive therapy within 4 weeks before treatment except physiologic corticosteroids
- Contraindications to intravesical therapy such as febrile illness, urinary tract infection, or gross hematuria on treatment day
- Active infection requiring systemic therapy within 4 weeks before treatment
- History of pneumonitis requiring steroids or current pneumonitis
- HIV infection
- Active Hepatitis B or C infection
- Pregnant or breastfeeding or planning pregnancy during study and 120 days after last dose
- Recent stroke, intracranial hemorrhage, pulmonary embolism, or thromboembolic event within 6 months
- History of allogeneic tissue or organ transplant
- Any condition or therapy interfering with study participation or cooperation as judged by investigator
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
B
Bernard Bochner, MD
CONTACT
E
Eugene Pietzak, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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