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PD-L1 Inhibitor

Atezolizumab for Bladder Cancer

Phase 2
Waitlist Available
Led By Nabil Adra, MD
Research Sponsored by Nabil Adra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from c1d1 until death or up to a maximum of 28 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that consists of either atezolizumab + carboplatin + gemcitabine or atezolizumab + docetaxel, compared to historical controls of chemotherapy only, in subjects with metastatic or recurrent urothelial carcinoma.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from c1d1 until death or up to a maximum of 28 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from c1d1 until death or up to a maximum of 28 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Clinical Benefit Rate (CBR) With RECIST 1.1
Clinical Benefit Rate (CBR) With irRECIST
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Carboplatin + Gemcitabine or Docetaxel
+7 more

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%
Respiratory tract infection
1%
Musculoskeletal chest pain
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

1Treatment groups
Experimental Treatment
Group I: Chemotherapy and AtezolizumabExperimental Treatment4 Interventions
Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Subjects that received sequential or concurrent PD1/PDL1 inhibitor and carboplatin-based regimen will be treated with atezolizumab + docetaxel on trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Atezolizumab
2017
Completed Phase 3
~5860
Carboplatin
2014
Completed Phase 3
~6670
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,683 Total Patients Enrolled
Indiana University School of MedicineOTHER
185 Previous Clinical Trials
142,787 Total Patients Enrolled
Nabil AdraLead Sponsor
4 Previous Clinical Trials
185 Total Patients Enrolled

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03737123 — Phase 2
Bladder Cancer Research Study Groups: Chemotherapy and Atezolizumab
Bladder Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03737123 — Phase 2
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03737123 — Phase 2

Frequently Asked Questions

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

What are the main purposes that Atezolizumab is used for?

"Atezolizumab is commonly used to treat non-hodgkin lymphoma. This medication can also be useful for patients with metastatic bladder cancer and those in need of advance directives."

Answered by AI

Is this study looking for more participants at the moment?

"According to the latest information on clinicaltrials.gov, this particular trial is not currently looking for new participants. The study was first announced on December 19th, 2018 but was last updated more recently on February 14th, 2022. There are 4223 other clinical trials that are recruiting patients right now though."

Answered by AI

What are the potential risks associated with Atezolizumab?

"Atezolizumab has not been proven effective yet in Phase 2 trials, but there is some data supporting its safety which Power rates as a 2."

Answered by AI

Are there any other locations conducting this research besides here?

"Currently, this trial is taking place in 4 locations. For the convenience of participants, these sites are situated in major cities including Cincinnati, Indianapolis and Omaha."

Answered by AI

Could you provide some context for Atezolizumab's therapeutic use?

"Atezolizumab is being trialed in 1623 different studies, 474 of which are currently in Phase 3. Shanghai, China hosts the majority of these trials, but there are a total of 88693 locations worldwide where patients can seek this treatment."

Answered by AI

How many people are included as participants in this clinical trial?

"As of February 14th, 2022 this trial is not looking for new patients. It was initially posted on December 19th, 2018. However, there are currently 2600 trials actively searching for patients with carcinoma and 1623 trials for Atezolizumab that are enrolling participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma
Nabil Adra 2018. "Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03737123.
~1 spots leftby Apr 2025
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