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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
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active heart condition.
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I have had radiation therapy to my bladder before.
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I have had an organ or stem cell transplant.
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I haven't taken steroids or immunosuppressants in the last 14 days.
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I have had chemotherapy for bladder cancer before.
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I have not received any vaccines within 4 weeks before the study, except for inactivated ones.
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My lymph nodes are enlarged or confirmed by biopsy.
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I have an autoimmune disease that could worsen with certain cancer treatments.
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I am allergic or have had severe reactions to certain protein treatments.
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I have previously been treated with experimental cancer drugs.
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I have previously received immunotherapy with specific antibodies.
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I do not have an active, uncontrolled HIV/AIDS infection.
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My liver condition is stable.
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My cancer has spread to other parts of my body.
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
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 moreAwards & 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].
[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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active heart condition.I have had radiation therapy to my bladder before.I have had an organ or stem cell transplant.More than half of my cancer is urothelial carcinoma.I haven't taken steroids or immunosuppressants in the last 14 days.I can take care of myself and perform daily activities.I have had chemotherapy for bladder cancer before.I am able to understand and sign the consent form.I have not received any vaccines within 4 weeks before the study, except for inactivated ones.You have a history of certain immune-related health conditions.I haven't had cancer in the last 2 years, except for certain skin cancers or early-stage breast, cervical, or low-grade prostate cancer.I am not using or unwilling to use effective birth control.I am 18 years old or older.My lymph nodes are enlarged or confirmed by biopsy.You have severe allergies to multiple medications or cannot tolerate topical corticosteroids.Your heart's electrical activity (QTc) is longer than 450 milliseconds for males, 470 milliseconds for females, or 480 milliseconds if you have a specific heart condition.My bladder cancer has spread into the muscle layer but not to lymph nodes or distant organs.My blood tests show my bone marrow is working well.I have an autoimmune disease that could worsen with certain cancer treatments.I am allergic or have had severe reactions to certain protein treatments.I have previously been treated with experimental cancer drugs.I have previously received immunotherapy with specific antibodies.I do not have an active, uncontrolled HIV/AIDS infection.My kidneys are working well enough (creatinine clearance ≥30 mL/min).My liver condition is stable.My cancer has spread to other parts of my body.I have not taken strong antibiotics for serious infections in the last 2 weeks.I am following the required birth control measures.My liver tests are within normal limits.
Research Study Groups:
This trial has the following groups:- Group 1: Open arm
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.
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