What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as hyperthermic intravesical chemotherapy (HIVEC) and trimodality therapy (TMT), generally have mild to moderate side effects. HIVEC often results in urinary frequency, incontinence, and urinary tract pain. TMT, which aims for bladder preservation, can cause urinary-irritative symptoms and bowel symptoms, with a small percentage of patients experiencing severe genitourinary or gastrointestinal toxicity. Overall, these treatments are well-tolerated, with most side effects being self-limiting and manageable.

What prior FDA approvals exist?

Several FDA-approved treatments for bladder cancer include immune checkpoint inhibitors and targeted therapies. Pembrolizumab and Avelumab are immune checkpoint inhibitors that have shown efficacy in treating advanced urothelial carcinoma, particularly in patients who have progressed after platinum-based chemotherapy. Enfortumab vedotin, an antibody-drug conjugate, has also been approved for patients with advanced urothelial carcinoma who have previously received PD-1 or PD-L1 inhibitors. These treatments focus on enhancing the body's immune response to cancer cells or targeting specific cancer cell markers, similar to the investigational approach of STM-416.

What other types of research exist?

Promising novel alternatives to STM-416 for bladder cancer patients include VAX014, an integrin-specific oncolytic biotherapeutic agent, which has shown potential as an immediate post-operative intravesical adjuvant therapy for non-muscle invasive bladder cancer (NMIBC). Additionally, BCG immunotherapy has been effective against bladder tumors expressing sialyl-Tn and sialyl-6-T antigens, which are independent predictive markers of treatment response. These alternatives offer new avenues for treatment and may improve patient outcomes.

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STM-416 for Bladder Cancer

Phase 1 & 2

Recruiting

Led By Boris Gershman, MD

Research Sponsored by SURGE Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have adequate organ and marrow function as defined below: Hemoglobin 9.0 g/dL, Absolute neutrophil count 1.5 × 109/L (1500 per mm3), Platelet count 75 × 109/L (75,000 per mm3), Serum bilirubin 1.5 × institutional upper limit of normal (ULN), AST/ALT 2.5 × institutional ULN, Creatinine CL 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL

Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Must not have

Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to resiquimod (R848), or excipients used in STM-416 including poloxamer 407 and sodium hyaluronate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests STM-416, a new treatment, in bladder cancer patients whose disease has returned after standard treatments. The treatment is given to see if it is safe and effective.

Who is the study for?

This trial is for adults over 18 with high-risk recurrent bladder cancer who are undergoing TURBT. They must have a certain level of physical fitness (ECOG 0-2) and adequate organ/marrow function. Excluded are those with invasive or carcinoma in situ bladder cancers, on other trials, allergic to similar drugs as STM-416, women who can become pregnant (only in early phases), and anyone with serious infections or unstable health conditions.

What is being tested?

The study tests STM-416's safety and tolerability in patients with bladder cancer. It's the first time this drug is being tried on humans (Phase 1/2a). The trial involves increasing doses to find out what amount is safe and how well it works when given during TURBT surgery for recurring non-muscle-invasive bladder cancer.

What are the potential side effects?

Since this is a first-in-human study of STM-416, specific side effects aren't yet known but may include typical reactions related to immune system activation such as fever, fatigue, skin reactions at the injection site, flu-like symptoms, and potential impacts on blood counts or liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts and liver/kidney functions are within safe ranges.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am allergic to ingredients similar to those in STM-416.

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I have a history of bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1

Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1

Recurrence free survival time (Phase 2a)

Secondary study objectives

Pharmacodynamics of STM-416

Pharmacokinetics of STM-416 (Phase 1)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: STM-416Experimental Treatment1 Intervention

STM-416

0 / 6Eligibility 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

Bladder cancer treatments often involve chemotherapy, radiation, and immunotherapy. Chemotherapy, such as cisplatin-based regimens, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Radiation therapy uses high-energy rays to target and kill cancer cells. Immunotherapy, including checkpoint inhibitors like atezolizumab and pembrolizumab, enhances the body's immune response against cancer cells by blocking proteins that suppress immune activity. These treatments are crucial for bladder cancer patients as they offer multiple approaches to target and eliminate cancer cells, potentially improving survival rates and preserving bladder function.

[The role of immunotherapy in the modern treatment of urothelial carcinoma].Emerging drugs for urothelial carcinoma.