← Back to Search

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
Must not have
Clinically significant (active) cardiovascular disease
Previous radiation therapy to the bladder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of radical cystectomy
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new treatment combining Sasanlimab, which helps the immune system fight cancer, with targeted radiation therapy. It is for patients with muscle-invasive bladder cancer who cannot receive standard chemotherapy. The treatment aims to boost the immune response and directly target cancer cells 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
More than half of my cancer is urothelial carcinoma.
Select...
I can take care of myself and perform daily activities.
Select...
I am 18 years old or older.
Select...
My bladder cancer has spread into the muscle layer but not to lymph nodes or distant organs.
Select...
My blood tests show my bone marrow is working well.
Select...
My kidneys are working well enough (creatinine clearance ≥30 mL/min).
Select...
My liver tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active heart condition.
Select...
I have had radiation therapy to my bladder before.
Select...
I have had an organ or stem cell transplant.
Select...
I haven't taken steroids or immunosuppressants in the last 14 days.
Select...
I have had chemotherapy for bladder cancer before.
Select...
I have not received any vaccines within 4 weeks before the study, except for inactivated ones.
Select...
My lymph nodes are enlarged or confirmed by biopsy.
Select...
I have an autoimmune disease that could worsen with certain cancer treatments.
Select...
I am allergic or have had severe reactions to certain protein treatments.
Select...
I have previously been treated with experimental cancer drugs.
Select...
I have previously received immunotherapy with specific antibodies.
Select...
I do not have an active, uncontrolled HIV/AIDS infection.
Select...
My liver condition is stable.
Select...
My cancer has spread to other parts of my body.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical benefit rate defined as pathologic complete response (pT0)
Composite outcome for Feasibility and Safety
Secondary study objectives
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

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: 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
~790

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].

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
285 Previous Clinical Trials
81,653 Total Patients Enrolled
PfizerIndustry Sponsor
4,650 Previous Clinical Trials
17,743,630 Total Patients Enrolled
Raj Satkunasivam, MDPrincipal InvestigatorHouston Methodist Hospital, Houston Methodist Research Institute

Media Library

Radical Cystectomy + Pelvic Lymph Node Dissection + Urinary Diversion Clinical Trial Eligibility Overview. Trial Name: NCT05241340 — Phase 2
Bladder Cancer Research Study Groups: Open arm
Bladder Cancer Clinical Trial 2023: Radical Cystectomy + Pelvic Lymph Node Dissection + Urinary Diversion Highlights & Side Effects. Trial Name: NCT05241340 — Phase 2
Radical Cystectomy + Pelvic Lymph Node Dissection + Urinary Diversion 2023 Treatment Timeline for Medical Study. Trial Name: NCT05241340 — Phase 2
~6 spots leftby Aug 2025