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Virus Therapy
2141-V11 for Bladder Cancer
Phase 1
Recruiting
Led By Bernard Bochner, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage, grade, and histology must be confirmed by the MSK Department of Pathology
Absence of urothelial carcinoma involving the upper urinary tract
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new drug, 2141-V11, for people with a certain type of bladder cancer that hasn't responded to other treatments. Researchers will test different doses to find the safest one, and also study how the drug is absorbed and processed by the body.
Who is the study for?
This trial is for adults with non-muscle invasive bladder cancer (NMIBC) that hasn't improved after standard treatment and who aren't having their bladder surgically removed. Participants must be over 18, in fairly good health, able to follow the treatment schedule, and have had recent exams confirming no cancer in the upper urinary tract. Women of childbearing age need a negative pregnancy test and all participants must agree to use contraception.Check my eligibility
What is being tested?
The study is testing different doses of a new drug called 2141-V11 for safety in people with NMIBC. It's one of the first trials on humans for this drug, which will be delivered directly into the bladder through a catheter. Researchers will also examine how the body processes this medication.See study design
What are the potential side effects?
Since this is an early-stage trial for 2141-V11, specific side effects are not yet fully known but may include typical reactions related to intravesical therapy such as discomfort or pain during administration, urinary symptoms like frequency or urgency, and potential local irritation within the bladder.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer's details were confirmed by the MSK Department of Pathology.
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I do not have bladder cancer that has spread to the kidneys or ureters.
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My bladder cancer is aggressive and hasn't responded to BCG therapy.
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My latest bladder exam shows carcinoma in situ on the tumor.
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I am 18 years old or older.
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I had a complete surgery to remove bladder tumors.
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I have chosen not to have or am not eligible for major bladder surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD/RP2D
Trial Design
1Treatment groups
Experimental Treatment
Group I: anti-CD40 antibody 2141-V11Experimental Treatment1 Intervention
Eligible subjects will receive the anti-CD40 antibody 2141-V11 administered by intravesical instillation once weekly for 3 consecutive weeks (weeks 1, 2, and 3) for a total of 3 doses.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,901 Total Patients Enrolled
Pin Down Bladder Cancer Research FoundationUNKNOWN
Rockefeller UniversityOTHER
158 Previous Clinical Trials
16,332 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My last bladder examination was within the last 60 days.My cancer's details were confirmed by the MSK Department of Pathology.I am not currently on any cancer treatments, including experimental drugs.I have completed the necessary BCG therapy.I do not have bladder cancer that has spread to the kidneys or ureters.My cancer is mainly urothelial despite having other types.I am a woman who can have children and have a recent negative pregnancy test.My bladder cancer is aggressive and hasn't responded to BCG therapy.I've had bladder treatments between my last bladder exam and starting this trial.My latest bladder exam shows carcinoma in situ on the tumor.My cancer has spread to areas like the urethra, ureter, or kidney.I cannot have treatments directly into my bladder due to health reasons.I am 18 years old or older.I have not taken immunosuppressive drugs or steroids in the last 4 weeks.I can follow the treatment schedule set by my doctor.I have had a transplant of tissue or an organ from another person.I had a complete surgery to remove bladder tumors.I agree to use effective birth control during and up to 120 days after the study.My bladder cancer did not respond to BCG therapy within the specified times.I have chosen not to have or am not eligible for major bladder surgery.I have advanced bladder cancer that cannot be surgically removed.I can care for myself and am up more than 50% of my waking hours.I have not had a blood clot in my lungs or any clotting event in the last 6 months.You need to have certain blood tests done within 28 days before starting the treatment.I haven't had cancer treatments like chemotherapy or radiation in the last 2 weeks.I have not had a stroke or brain bleed in the last 6 months.I have another cancer that has worsened or needed treatment in the last 3 years.You have had a serious autoimmune disease that needed strong medication in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: anti-CD40 antibody 2141-V11
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are contributing to this research endeavor?
"Affirmative. Clinicaltrials.gov denotes that this investigation, which was launched on November 8th 2021, is currently recruiting participants. There are 25 slots to be filled across 7 distinct medical sites."
Answered by AI
Has the FDA sanctioned 2141-V11 for public consumption?
"Due to the nascent nature of this Phase 1 trial, 2141-V11 was assigned a safety score of 1. This reflects that there is limited data on its efficacy and safety."
Answered by AI
Are there still vacancies for participants in this experiment?
"Indeed, the information hosted on clinicaltrials.gov reveals that this medical trial is currently seeking applicants. It was initially posted on November 8th 2021 and has been amended as recently as December 7th 2021. 25 individuals need to be recruited from seven distinct sites."
Answered by AI
How many health care facilities are administering this research project in the city?
"Presently, this clinical trial is hosted in 7 medical sites spread across the United States. For instance, Basking Ridge, Uniondale and Montvale are a few of those locations. If you enroll it may be wise to choose one nearby so as to minimize travel needs."
Answered by AI
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