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Checkpoint Inhibitor
Stereotactic Body Radiation Therapy for Bladder Cancer
Phase 2
Recruiting
Led By Himanshu Nagar
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have at least one measurable site >= 1 cm in diameter per RECIST 1.1 and a site targetable for radiotherapy
Platinum-refractory criteria: Prior platinum-based perioperative chemotherapy within 12 months of relapse, Prior platinum-based chemotherapy for metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization until disease progression as assessed by the treating physician using recist 1.1 or death due to any cause, assessed up to 3 years
Awards & highlights
Study Summary
This trial is testing whether adding radiation therapy to atezolizumab helps people with urothelial cancer live longer compared to atezolizumab alone.
Who is the study for?
This trial is for adults with metastatic urothelial cancer who've had prior platinum-based chemotherapy, can provide tissue for PD-L1 testing or agree to a biopsy, and have at least one measurable tumor. They should not have severe peripheral neuropathy, advanced heart failure, or impaired kidney function. An ECOG performance status of >2 (which means they are quite ill) also disqualifies them.Check my eligibility
What is being tested?
The study is examining if adding Stereotactic Body Radiation Therapy (SBRT), which precisely targets tumors with high-energy X-rays in fewer doses, to the immunotherapy drug Atezolizumab improves outcomes compared to Atezolizumab alone in patients with spreading urothelial cancer.See study design
What are the potential side effects?
Potential side effects include those from Atezolizumab like immune-related inflammation of organs and infusion reactions. SBRT may cause localized skin irritation and fatigue. The combination could potentially increase these risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor larger than 1 cm that can be targeted with radiation.
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My cancer did not respond to previous platinum-based chemotherapy.
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I can take care of myself but might not be able to do heavy physical work.
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I do not have any significant liver disease.
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I have at least one tumor that can be measured.
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I have never been treated with PD1/PDL1 inhibitors.
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My liver enzymes are within acceptable limits for someone with liver cancer.
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I have not had a bone marrow or organ transplant.
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I haven't had treatments that boost the immune system recently.
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I haven't had radiation on the cancer area that can be targeted or measured.
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I cannot receive platinum-based chemotherapy due to kidney issues, physical limitations, severe nerve pain, or advanced heart failure.
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My cancer is a confirmed metastatic bladder cancer.
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I have not had treatments involving CD137 agonists or immune checkpoint blockers.
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I do not have active tuberculosis.
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I haven't needed treatment for an autoimmune disease in the last 2 years.
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I have no history or current issues with lung or colon inflammation not caused by infections.
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I have no history of serious lung conditions.
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I do not have serious heart problems.
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I have never had cancer spread to the lining of my brain and spinal cord.
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I do not have pain from my cancer that is not managed by medication.
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I have had treatment for all my known lesions before joining.
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I have type 1 diabetes that is under control with a stable insulin routine.
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I do not need frequent procedures to remove fluid build-ups.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from randomization until disease progression as assessed by the treating physician using recist 1.1 or death due to any cause, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization until disease progression as assessed by the treating physician using recist 1.1 or death due to any cause, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Incidence of adverse events
Overall survival
Progression-free survival
+2 moreSide effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Anorexia
21%
Chest pain
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Dehydration
7%
Blurred vision
7%
Sinusitis
7%
Otitis externa
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Hypertension
7%
Creatinine increased
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (pembrolizumab, SBRT)Experimental Treatment8 Interventions
Patients receive pembrolizumab as in Arm A. Patients also undergo SBRT QD every other day for 3 fractions over 2 weeks that must be completed before 12 weeks after the first dose of pembrolizumab in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan, and/or PET scan, as well as optional urine and blood sample collection throughout the study.
Group II: Arm A (pembrolizumab)Experimental Treatment7 Interventions
Patients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan and/or PET scan, as well as optional urine and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Pembrolizumab
2017
Completed Phase 2
~2010
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,655 Previous Clinical Trials
40,933,075 Total Patients Enrolled
Himanshu NagarPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what geographic areas has this clinical investigation been conducted?
"This clinical study is being conducted at 55 different locations, such as the University of Missouri - Ellis Fishel in Columbia, Saint Joseph Mercy Brighton in Ypsilanti and Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus in Pottsville."
Answered by AI
What are Quality-of-Life Assessments typically used to measure?
"Quality-of-Life Assessment is largely used for small cell lung cancer, though it can also benefit patients suffering from malignant neoplasms, non-small cell lung carcinoma, and postoperative conditions."
Answered by AI
What is the current enrollment cap for this research program?
"This clinical trial requires 144 individuals that meet the eligibility requirements. Patients from University of Missouri - Ellis Fischel in Columbia, Missouri and Saint Joseph Mercy Brighton in Ypsilanti, Pennsylvania have access to enrolling in this study."
Answered by AI
What previous investigations have been conducted regarding Quality-of-Life Evaluation?
"Quality-of-Life Assessment was first explored in 2008 at SCRI Tennessee Oncology Chattanooga, with 326 trials having been concluded and 351 presently recruiting. Notably, many of these studies are located in Columbia, Missouri."
Answered by AI
Has the Quality-of-Life Assessment been accepted by regulatory authorities?
"The efficacy of Quality-of-Life Assessments has yet to be established, so it was given a safety rating of 2 on our team's 1-3 scale. This is due to the fact that this particular trial is in Phase 2 and there are some data points supporting its safety."
Answered by AI
Are there opportunities for individuals to join this clinical experimentation presently?
"Affirmative. Clinicaltrials.gov records show that this medical trial, initially published on December 1st 2021, continues to search for participants. The study is currently seeking 144 patients from 55 different clinical sites."
Answered by AI
Has this experiment been attempted previously?
"Currently, 351 active studies related to Quality-of-Life Assessment are occurring in 1646 cities and 74 countries. The trailblazer for this research was Hoffmann-La Roche's Phase 2 drug approval study which took place in 2008 with 720 participants involved. Since then, 326 trials have concluded their investigations."
Answered by AI
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