Atezolizumab for Urinary Bladder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Urinary Bladder+30 More
Atezolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Urinary Bladder
  • Stage IV Urethral Cancer AJCC v8
  • Stage IV Bladder Cancer AJCC v8
  • Malignant neoplasm of ureter
  • Renal pelvis
  • Metastatic Urethral Urothelial Carcinoma
  • Recurrent Urethral Urothelial Carcinoma
  • Advanced Ureter Urothelial Carcinoma
  • Stage III Urethral Cancer AJCC v8
  • Metastatic Ureter Urothelial Carcinoma
  • Metastatic Renal Pelvis Urothelial Carcinoma
  • Ureter
  • Metastatic Bladder Urothelial Carcinoma
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Neoplasms
Clinical benefit rate (CBR) measured by RECIST version (v.) 1.1 and immune-related (ir) RECIST
Duration of response (DOR)
Objective response rate (ORR)
Overall survival
Progression-free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Atezolizumab
27%Fatigue
25%Decreased appetite
24%Cough
19%Asthenia
19%Dyspnoea
18%Constipation
18%Nausea
18%Pyrexia
16%Diarrhoea
13%Arthralgia
12%Vomiting
12%Anaemia
11%Rash
11%Back pain
11%Musculoskeletal pain
10%Headache
9%Oedema peripheral
9%Weight decreased
9%Insomnia
9%Chest pain
9%Pruritus
9%Pain in extremity
8%Dizziness
7%Aspartate aminotransferase increased
7%Haemoptysis
7%Upper respiratory tract infection
7%Myalgia
6%Influenza like illness
6%Alanine aminotransferase increased
6%Bronchitis
6%Nasopharyngitis
6%Productive cough
5%Dry skin
5%Depression
5%Musculoskeletal chest pain
4%Urinary tract infection
4%Paraesthesia
4%Neuropathy peripheral
4%Abdominal pain
3%Stomatitis
3%Pneumonia
3%Dysgeusia
2%Pleural effusion
2%Malaise
2%Neutropenia
1%Respiratory tract infection
1%Pulmonary embolism
1%Peripheral sensory neuropathy
1%Sepsis
1%Pneumonitis
1%Alopecia
1%Mucosal inflammation
1%Bone pain
1%Lacrimation increased
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02008227) in the Atezolizumab ARM group. Side effects include: Fatigue with 27%, Decreased appetite with 25%, Cough with 24%, Asthenia with 19%, Dyspnoea with 19%.

Trial Design

2 Treatment Groups

Group 1 (CYT107, atezolizumab)
1 of 2
Group 2 (atezolizumab)
1 of 2
Experimental Treatment

54 Total Participants · 2 Treatment Groups

Primary Treatment: Atezolizumab · No Placebo Group · Phase 2

Group 1 (CYT107, atezolizumab)Experimental Group · 3 Interventions: Glycosylated Recombinant Human Interleukin-7, Atezolizumab, Laboratory Biomarker Analysis · Intervention Types: Biological, Drug, Other
Group 2 (atezolizumab)Experimental Group · 2 Interventions: Atezolizumab, Laboratory Biomarker Analysis · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-7
Not yet FDA approved
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,834 Total Patients Enrolled
Evan Y YuPrincipal InvestigatorCancer Immunotherapy Trials Network

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients with tumors that are a mix of histology, including urothelial carcinoma, are allowed to participate in the study.
cell type is lung squamous cell carcinoma
within 28 days prior to study start Patients must have a measurable disease according to RECIST 1.1 that is assessed by a CT scan or MRI within 28 days prior to study start.
Patients with bladder cancer that has spread to other parts of the body, or is inoperable, may be eligible for this study.
This means that patients must have had recurrent cancer after any previous treatment with platinum-based chemotherapy.
The person has an ECOG performance status of less than or equal to 2, which means that they have a Karnofsky score of at least 60%.
To be a suitable candidate for liver transplant, a patient must have a life expectancy of greater than or equal to 12 weeks.
is the only predictor of risk for VAP If the absolute neutrophil count is more than 1,000/mcL, the person is at risk for developing VAP.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.