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Checkpoint Inhibitor

Atezolizumab + CYT107 for Bladder Cancer

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.

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 below
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My kidneys are working well enough (creatinine clearance >= 30 mL/min).
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My cancer is not mainly small cell or neuroendocrine.
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I am HIV-positive, on stable HAART, with CD4 count over 250 and undetectable viral load.
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My cancer can be measured on scans.
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My cancer has returned after treatment with 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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My cancer originates from the urinary system and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Clinical benefit rate (CBR) measured by RECIST version (v.) 1.1 and immune-related response criteria (irRC)
Duration of response (DOR)
Overall survival (OS)
+1 more
Other outcome measures
Neoplasms

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Musculoskeletal chest pain
1%
Respiratory tract infection
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 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 II: 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
Glycosylated Recombinant Human Interleukin-7
2013
Completed Phase 2
~60
Positron Emission Tomography and Computed Tomography Scan
2015
N/A
~20
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Atezolizumab
2017
Completed Phase 3
~5860
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,708 Previous Clinical Trials
40,932,682 Total Patients Enrolled
Evan Y YuPrincipal InvestigatorCancer Immunotherapy Trials Network

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03513952 — Phase 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03513952 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~8 spots leftby May 2025