← Back to Search
Checkpoint Inhibitor
Atezolizumab + CYT107 for Bladder Cancer
Seattle, WA
Phase 2
Waitlist Available
Led By Evan Y Yu
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
Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault
Small cell or neuroendocrine carcinoma is not allowed if predominant
Must not have
Patients with active underlying autoimmune disease requiring systemic immunosuppressive medication
Patients with active tuberculosis (TB)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies atezolizumab given with glycosylated recombinant human interleukin-7 to see how well it works in treating patients with urothelial carcinoma.
See full description
Who is the study for?
This trial is for adults with advanced urothelial carcinoma that can't be surgically removed or has spread. Participants need functioning major organs, measurable disease by scans, a life expectancy of at least 12 weeks, and must not have predominant small cell/neuroendocrine carcinoma. They should agree to use contraception and not have had certain prior treatments like anti-PD-1/L1 antibodies.Check my eligibility
What is being tested?
The study tests the effectiveness of Atezolizumab (an immunotherapy drug) combined with CYT107 (a stimulator of the immune system) in treating locally advanced or metastatic urothelial carcinoma compared to Atezolizumab alone. It's a phase II trial involving imaging scans and biomarker analysis.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells leading to inflammation, infusion-related reactions from receiving drugs through veins, fatigue, potential liver issues due to Atezolizumab, and risks associated with stimulating the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are working well enough (creatinine clearance >= 30 mL/min).
show original
Select...
My cancer is not mainly small cell or neuroendocrine.
show original
Select...
I am HIV-positive, on stable HAART, with CD4 count over 250 and undetectable viral load.
show original
Select...
My cancer can be measured on scans.
show original
Select...
My cancer has returned after treatment with platinum-based chemotherapy.
show original
Select...
I can take care of myself but might not be able to do heavy physical work.
show original
Select...
My cancer originates from the urinary system and cannot be removed by surgery.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on medication for an autoimmune disease.
show original
Select...
I have active tuberculosis.
show original
Select...
I have had more than 2 chemotherapy treatments for bladder cancer.
show original
Select...
I have recovered from side effects of previous treatments, except for hair loss.
show original
Select...
I am on bisphosphonate therapy for high calcium levels.
show original
Select...
I have antibodies for hepatitis C but no active virus.
show original
Select...
I have had lung conditions like pulmonary fibrosis or pneumonitis.
show original
Select...
I have cancer that has spread to the lining of my brain and spinal cord.
show original
Select...
I have previously been treated with drugs targeting the PD-1 or PD-L1 pathway.
show original
Select...
I do not have significant liver disease such as hepatitis, cirrhosis, or fatty liver.
show original
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Clinical Benefit Rate (CBR) Measured by RECIST v1.1
Duration of Response (DOR)
Overall Survival (OS)
+1 moreOther study objectives
Assessment of Investigation Treatment Combination on the Immune-bias of the Tumor Microenvironment
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Pneumonia
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Safety run in phaseExperimental Treatment8 Interventions
Patients assigned to the experimental arm (atezolizumab + CYT107). If the treatment combination of the experimental arm demonstrates an acceptable safety profile in the Safety Run-In (one or fewer patient experiences a protocol-defined Dose Limiting-Toxicity), randomized enrollment into the trial will begin. The Run-in phase patients will be analyzed and reported separately both for safety and for efficacy.
Group II: Group 1 (CYT107, atezolizumab)Experimental Treatment8 Interventions
Patients receive CYT107 IM on days 1, 8, 15, and 22, and atezolizumab IV over 60 minutes on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab IV over 30-60 minutes on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI scans, and collection of blood and stool samples on study. Patients may also undergo tumor biopsy at screening and on study.
Group III: Group 2 (atezolizumab)Active Control7 Interventions
Patients receive atezolizumab IV over 60 minutes on cycle 1. Following cycle 1, patients receive atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI scans, and collection of blood and stool samples on study. Patients may also undergo tumor biopsy at screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1210
Computed Tomography
2017
Completed Phase 2
~2440
Glycosylated Recombinant Human Interleukin-7
2013
Completed Phase 2
~110
Magnetic Resonance Imaging
2020
Completed Phase 3
~1180
Atezolizumab
2016
Completed Phase 3
~5860
Biospecimen Collection
2004
Completed Phase 3
~1810
Positron Emission Tomography and Computed Tomography Scan
2015
Completed Phase 2
~70
Find a Location
Closest Location:University of Chicago Comprehensive Cancer Center· Chicago, IL· 272 miles
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
14,057 Previous Clinical Trials
41,149,381 Total Patients Enrolled
Evan Y YuPrincipal InvestigatorCancer Immunotherapy Trials Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
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.