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Atezolizumab for Transitional Cell Carcinoma

Phase 2

Waitlist Available

Led By Lawrence Fong, MD

Research Sponsored by Lawrence Fong

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 up to 2 years

Awards & highlights

Study Summary

This trial is testing the best dose of atezolizumab, an immunotherapy drug, for bladder cancer patients whose cancer has not spread.

Eligible Conditions

Transitional Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Body Weight Changes

+5 more

Secondary outcome measures

Association of tumor and T-cell PD-L1/PD-1 immunohistochemical expression with disease response

Near complete pathologic response rate

Overall Survival Rate

+1 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

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Pain in extremity

Peripheral sensory neuropathy

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Lower respiratory tract infection

Acute kidney injury

Depression

Musculoskeletal chest pain

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort A3: Atezolizumab MonotherapyExperimental Treatment1 Intervention

Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)

Group II: Cohort A2: Atezolizumab Monotherapy (Closed to enrollmentExperimental Treatment1 Intervention

Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)

Group III: Cohort A1: Atezolizumab Monotherapy (Closed to enrollment)Experimental Treatment1 Intervention

Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,648 Previous Clinical Trials

40,931,721 Total Patients Enrolled

The V FoundationOTHER

6 Previous Clinical Trials

146 Total Patients Enrolled

Lawrence FongLead Sponsor

5 Previous Clinical Trials

110 Total Patients Enrolled

Frequently Asked Questions

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

Are there any patients who have not yet been enrolled in this experiment?

"This particular clinical trial, as indicated by the most recent update on clinicaltrials.gov, is not looking for any new patients at this time. Although this may be the case, there are nearly 3000 other trials that have active recruitment goals."

Answered by AI

Has this clinical trial been conducted before?

"MPDL3280A Dose Level 1 was first studied in 2008 and has been under investigation for over a decade with 356 active trials. The initial clinical trial occurred in 2008 and was sponsored by Hoffmann-La Roche. MPDL3280A Dose Level 1 received its Phase 2 drug approval after the first study, which involved 720 patients. Now, there are 74 countries and 1665 cities with active research teams investigating MPDL3280A's efficacy."

Answered by AI

What does this study hope to gain knowledge about?

"The purpose of this medical trial is to observe the change in CD4+ FoxP3- helper T cell count/µm2 over the course of a year. Additionally, researchers will be secondary outcomes including the frequency of all grade treatment-related toxicities and 2-year relapse-free survival rate in expansion cohort Intention-To-Treat (ITT) population."

Answered by AI

Is the dosage of MPDL3280A at Level 1 safe for consumption according to the FDA?

"This is a Phase 2 trial, which means that while there is some evidence supporting the safety of MPDL3280A Dose Level 1, there is no efficacy data. Our team at Power scored it a 2."

Answered by AI