What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as immune checkpoint inhibitors and stereotactic body radiation therapy (SBRT), have distinct side effect profiles. Immune checkpoint inhibitors like Sasanlimab can cause immune-related adverse events including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. SBRT may lead to fatigue, urinary symptoms (e.g., frequency, urgency, dysuria), and gastrointestinal symptoms (e.g., diarrhea, rectal bleeding). Combining these treatments may increase the risk of these side effects.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of bladder cancer. Pembrolizumab and Atezolizumab are notable examples, both approved for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy. These drugs target the PD-1/PD-L1 pathway, similar to Sasanlimab. Additionally, Enfortumab Vedotin, an antibody-drug conjugate, has been approved for patients who have previously received immune checkpoint inhibitors. While stereotactic body radiation therapy (SBRT) as an in-situ vaccination is still under investigation, these approvals highlight the growing role of immunotherapy in bladder cancer treatment.

What other types of research exist?

Promising novel alternatives for bladder cancer treatment in 2024 include: <ol> <li>Enfortumab Vedotin: An antibody-drug conjugate targeting Nectin-4, showing efficacy in patients who have progressed after platinum-based chemotherapy and PD-1/PD-L1 inhibitors.</li> <li></li> </ol> Sacituzumab Govitecan: An antibody-drug conjugate targeting Trop-2, demonstrating significant activity in metastatic urothelial carcinoma after prior chemotherapy and immunotherapy. 3. Pembrolizumab: A PD-1 inhibitor, particularly effective as a second-line therapy for advanced urothelial carcinoma. 4. Atezolizumab: A PD-L1 inhibitor, offering a survival benefit in patients with platinum-treated locally advanced or metastatic urothelial carcinoma. 5. Bacillus Calmette-Guerin (BCG): For non-muscle invasive bladder cancer, BCG remains a highly effective intravesical therapy, especially for high-risk patients.

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Immunotherapy + Radiation for Bladder Cancer (RAD-VACCINE Trial)

Phase 2

Recruiting

Led By Raj Satkunasivam, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

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

Must have

Predominant (>50%) urothelial carcinoma histology

ECOG Eastern Cooperative Oncology Group performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of radical cystectomy

Awards & highlights

RAD-VACCINE Trial Summary

This trial is testing a new way to treat bladder cancer by combining an immunotherapy drug with radiation.

Who is the study for?

This trial is for adults with muscle-invasive bladder cancer who can't have cisplatin chemotherapy. They need good bone marrow and kidney function, no severe infections or heart issues recently, and no history of certain autoimmune diseases or other cancers in the last 2 years. Participants must be willing to use effective contraception.Check my eligibility

What is being tested?

The study tests Sasanlimab (an immune checkpoint inhibitor) combined with stereotactic body radiation therapy before surgery for bladder cancer. It's a phase II trial where all participants receive this combination as a potential 'in-situ vaccine' to boost their immune response against the cancer.See study design

What are the potential side effects?

Sasanlimab may cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems, and infusion reactions. Radiation therapy might lead to localized skin irritation, fatigue, and discomfort.

RAD-VACCINE Trial Eligibility Criteria

Inclusion Criteria

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

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More than half of my cancer is urothelial carcinoma.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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My bladder cancer has spread into the muscle layer but not to lymph nodes or distant organs.

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My blood tests show my bone marrow is working well.

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My kidneys are working well enough (creatinine clearance ≥30 mL/min).

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My liver tests are within normal limits.

RAD-VACCINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of radical cystectomy to date of death, assessed up to 30 days following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of radical cystectomy to date of death, assessed up to 30 days following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of radical cystectomy to date of death, assessed up to 30 days following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical benefit rate defined as pathologic complete response (pT0)

Composite outcome for Feasibility and Safety

Secondary outcome measures

Health Related Quality of Life for Patients with T2-T4 muscle invasive bladder cancer

Incidence of adverse events graded by NCI CTCAE version 5.0

Incidence of major surgical complications graded by Clavien-Dindo Scale

+2 more

RAD-VACCINE Trial Design

1Treatment groups

Experimental Treatment

Group I: Open armExperimental Treatment3 Interventions

All patients will receive study interventions (sasanlimab and SBRT) and standard-of-care radical cystectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 7Eligibility 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

Immune checkpoint inhibitors, such as Sasanlimab, work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. Stereotactic body radiation therapy (SBRT) delivers high doses of radiation precisely to the tumor, causing direct DNA damage to cancer cells and potentially converting the tumor into an in-situ vaccine that stimulates a systemic immune response. These mechanisms are crucial for bladder cancer patients, especially those ineligible for traditional chemotherapy, as they offer alternative therapeutic options that harness the body's own immune system to fight cancer more effectively.

[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.]Immunotherapy for the Treatment of Urothelial Carcinoma.[The role of immunotherapy in the modern treatment of urothelial carcinoma].