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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 from date of registration to date of death due to any cause, assessed up to 12 weeks after 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 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.
RAD-VACCINE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of registration to date of death due to any cause, assessed up to 4 weeks after radical cystectomy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to date of death due to any cause, assessed up to 4 weeks after radical cystectomy
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 moreRAD-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
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
271 Previous Clinical Trials
80,342 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,952 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the goals that this research is trying to achieve?
"The goal of this study is to improve clinical outcomes for patients with bladder cancer. To do this, the research team will measure a number of factors including quality of life, overall survival rates, and recurrence-free survival rates."
Answered by AI
Are there any patients still needed for this clinical trial?
"The trial, which was last updated on 2/15/2022, is seeking patients. The clinicaltrials.gov page for this study was created on 2/15/2022."
Answered by AI
How many people are being observed in this research?
"That is correct, the clinicaltrials.gov website provides information that this study is still looking for 33 participants from 1 location(s). The trial was first posted on February 15th, 2022 and last updated on the same day."
Answered by AI
Is there a risk for serious side effects with Sasanlimab?
"Sasanlimab's safety is based on Phase 2 trial data, meaning that while there is evidence that it is safe, its efficacy has not been proven."
Answered by AI
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