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Atezolizumab + CYT107 for Bladder Cancer
Study Summary
This trial studies atezolizumab given with glycosylated recombinant human interleukin-7 to see how well it works in treating patients with urothelial carcinoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT02008227Trial Design
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Who is running the clinical trial?
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- I am on medication for an autoimmune disease.I haven't had treatments that boost the immune system in the last 6 weeks.I have active tuberculosis.You have a platelet count of at least 100,000 per microliter.Your total bilirubin level should be within a certain range, unless you have a condition called Gilbert's disease.My kidneys are working well enough (creatinine clearance >= 30 mL/min).You have had a bone marrow or organ transplant from someone else in the past.I have had more than 2 chemotherapy treatments for bladder cancer.I have recovered from side effects of previous treatments, except for hair loss.I have been treated with anti-CTLA-4 therapy under certain conditions.Your hemoglobin level is 8 grams per deciliter or higher.Your liver enzymes (AST and/or ALT) are not more than 3 times the upper limit of normal. If you have liver involvement, they should not be more than 5 times the upper limit of normal.My doctor may check my kidney function with a special urine test if needed.I am on bisphosphonate therapy for high calcium levels.I have a brain tumor or cancer spread to my brain, with certain exceptions.I have antibodies for hepatitis C but no active virus.My cancer is not mainly small cell or neuroendocrine.Your absolute neutrophil count must be at least 1,000 per microliter of blood.I am HIV-positive, on stable HAART, with CD4 count over 250 and undetectable viral load.I have cancer that has spread to the lining of my brain and spinal cord.My cancer is mainly urothelial carcinoma, even if mixed with other types.My cancer can be measured on scans.I have had lung conditions like pulmonary fibrosis or pneumonitis.I haven't taken any immune-weakening drugs in the last 2 weeks.I have had signs of an infection in the last 2 weeks.My cancer has returned after treatment with platinum-based chemotherapy.I have previously been treated with drugs targeting the PD-1 or PD-L1 pathway.You have a low number of white blood cells.I have not had any other cancer besides UBC in the last 2 years, with some exceptions.I have not taken any antibiotics in the last 2 weeks.Your alkaline phosphatase level must be within a certain range, unless you have liver involvement or bone metastases.I haven't had a severe infection in the last 4 weeks.Your blood clotting tests should not be more than 1.5 times the upper limit of normal, unless you are already receiving anticoagulation treatment.You are allergic to Chinese hamster ovary cell products or other similar types of medication.I do not have significant liver disease such as hepatitis, cirrhosis, or fatty liver.I can take care of myself but might not be able to do heavy physical work.I can provide a recent or new biopsy sample of my tumor.I had hepatitis B in the past but it's resolved now.I am a woman who can have children and have a recent negative pregnancy test.I haven't had chemotherapy or radiotherapy in the last 2-4 weeks.I have not received a live vaccine in the last 4 weeks.My cancer originates from the urinary system and cannot be removed by surgery.
- 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
How many health care facilities are currently implementing this trial?
"This investigation is currently taking place in 9 facilities, located within the cities of Saint Louis, Metairie, and Tampa as well as 6 other metropolitan hubs. To lessen any traveling stressors associated with enrollment, it is beneficial to choose a clinic closest to you."
Has the Food and Drug Administration given Atezolizumab its stamp of approval?
"Despite being in a Phase 2 trial, which has yet to elicit efficacy data for Atezolizumab, our team at Power have rated its safety as a 2."
What precedent exists for the utilization of Atezolizumab in medical trials?
"Atezolizumab has been the subject of 654 clinical trials since its initial study in 2008 at SCRI Tennessee Oncology Chattanooga. Currently, 353 live studies are underway with many taking place near Saint Louis, Missouri."
What is the highest possible participant count for this trial?
"Affirmative, according to clinicaltrials.gov the research is soliciting participants with a posting date of September 28th 2018 and an update on October 28th 2022. 54 individuals will be accepted from 9 different locations."
To what end is Atezolizumab commonly prescribed?
"Atezolizumab is commonly used to combat small cell lung cancer and can be utilized in the treatment of malignant neoplasms, non-small cell lung carcinoma, and postoperative conditions."
Has this experiment already been conducted successfully elsewhere?
"As of today, 353 studies related to Atezolizumab are ongoing across 74 nations and 1645 cities. The first clinical trial commenced in 2008, sponsored by Hoffmann-La Roche with 720 patients involved. After Phase 2 approval was achieved, a total of 654 trials have since been finalized."
Does this experiment involve actively enlisting participants?
"Affirmative. According to clinicaltrials.gov, this experimental research is still recruiting participants who were initially posted on September 28th 2018 and last updated on October 28th 2022. 54 volunteers are required for the trial across 9 distinct locations."
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