What side effects are associated with this type of intervention?

Common treatments for bladder cancer, including chemotherapy, immunotherapy, and surgical interventions, have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections. Immunotherapy, such as checkpoint inhibitors, may lead to immune-related adverse effects like colitis, hepatitis, and pneumonitis. Surgical treatments, including cystectomy, can result in complications such as infections, bleeding, and issues related to urinary diversion. For non-muscle invasive bladder cancer, intravesical therapies can cause bladder irritation, pain, and urinary frequency. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the patient's specific needs and health status.

What prior FDA approvals exist?

Several FDA-approved drugs are used for the treatment of bladder cancer, particularly in cases where standard treatments have failed. Atezolizumab and pembrolizumab are immune checkpoint inhibitors approved for advanced or metastatic urothelial carcinoma, especially in patients ineligible for cisplatin-based chemotherapy. Enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4, is approved for patients who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Sacituzumab govitecan, another antibody-drug conjugate, targets Trop-2 and is approved for patients with metastatic urothelial carcinoma who have progressed after platinum-based chemotherapy and checkpoint inhibitors. Erdafitinib, a fibroblast growth factor receptor (FGFR) inhibitor, is approved for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations.

What other types of research exist?

Promising novel alternatives to 2141-V11 for bladder cancer patients include VAX014, an integrin-specific oncolytic biotherapeutic agent, and enfortumab vedotin, which has shown efficacy in patients previously treated with platinum and PD-1/PD-L1 inhibitors. Additionally, immune checkpoint inhibitors like pembrolizumab and nivolumab are also viable options.

← Back to Search

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

Must not have

Concurrent anti-cancer therapy, including investigational agents

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called 2141-V11 in people with bladder cancer that didn't respond to other treatments and who won't have surgery. The drug is delivered directly into the bladder to see if it is safe.

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.

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.

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 below

Select...

My cancer's details were confirmed by the MSK Department of Pathology.

Select...

I do not have bladder cancer that has spread to the kidneys or ureters.

Select...

My bladder cancer is aggressive and hasn't responded to BCG therapy.

Select...

My latest bladder exam shows carcinoma in situ on the tumor.

Select...

I am 18 years old or older.

Select...

I had a complete surgery to remove bladder tumors.

Select...

I have chosen not to have or am not eligible for major bladder surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not currently on any cancer treatments, including experimental drugs.

Select...

My cancer has spread to areas like the urethra, ureter, or kidney.

Select...

I cannot have treatments directly into my bladder due to health reasons.

Select...

I have had a transplant of tissue or an organ from another person.

Select...

I have advanced bladder cancer that cannot be surgically removed.

Select...

I have not had a blood clot in my lungs or any clotting event in the last 6 months.

Select...

I have another cancer that has worsened or needed treatment in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD/RP2D (Cohort A)

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: (Cohort C) expansion cohort 10 mg of 2141-V11Experimental Treatment1 Intervention

For patients in Cohort C, 10 mg of 2141-V11 will be administered as an intratumoral injection during standard of care cystoscopy prior to and within four weeks of planned radical cystectomy.

Group II: (Cohort B) 2141-V11, a fixed dose of 10mgExperimental Treatment1 Intervention

For patients who are ineligible for radical cystectomy or have elected not to undergo the procedure.

Group III: (Cohort A) anti-CD40 antibody 2141-V11Experimental Treatment1 Intervention

Intravesically or intratumorally) of an anti-CD40 agonist antibody (2141-V11) for the treatment of subjects with BCG-unresponsive NMIBC who are considered ineligible for or have elected not to undergo radical cystectomy.

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bladder cancer include chemoradiation, intravesical BCG, and immunotherapy. Chemoradiation combines chemotherapy and radiation to enhance the cancer-killing effects of both treatments, leading to higher complete response rates and improved survival. Intravesical BCG works by stimulating the immune system to attack cancer cells within the bladder, making it effective for non-muscle invasive bladder cancer. Immunotherapy, including checkpoint inhibitors like atezolizumab and pembrolizumab, helps the immune system recognize and destroy cancer cells. These treatments are crucial as they offer bladder-sparing options and improve survival rates, which is particularly important for patients who are not candidates for radical cystectomy or who prefer to avoid bladder removal.

[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.][The role of immunotherapy in the modern treatment of urothelial carcinoma].Emerging drugs for urothelial carcinoma.