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Checkpoint Inhibitor

Atezolizumab + Chemotherapy for Bladder Cancer

Phase 2

Recruiting

Led By Jean Hoffman-Censits, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old at time of consent

Agreement for men to remain abstinent or use contraceptive measures

Must not have

Prior systemic treatment for small-cell bladder cancer (SCBC)

Prior allogeneic stem cell or solid organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combining atezolizumab, platinum, and etoposide for patients with locally advanced urothelial cancer. The goal is to see if this new treatment can help patients achieve a pathologic complete response (no cancer cells remaining) at cystectomy (surgery to remove the bladder).

Who is the study for?

This trial is for adults with small cell bladder cancer who haven't had prior systemic treatment for it. They must be fit enough for chemo, immunotherapy, and surgery, have a performance status of 0 or 1, and agree to use birth control. A tumor sample is needed before joining. People with recent other cancers, severe allergies to drugs in the study, active infections like HIV or hepatitis B, or certain heart conditions can't join.

What is being tested?

The trial tests atezolizumab combined with platinum (carboplatin or cisplatin) and etoposide chemotherapy in patients undergoing cystectomy (bladder removal surgery). It's a Phase II study focusing on how many patients achieve no sign of cancer after this combination therapy.

What are the potential side effects?

Possible side effects include immune-related reactions that may affect organs; infusion reactions from the drug entering the body; blood disorders; fatigue; increased risk of infections due to weakened immunity; kidney problems especially if using cisplatin which requires good kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old.

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I agree to either not have sex or use birth control.

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I need a new biopsy for testing if my stored cancer tissue isn't suitable.

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My bladder cancer is confirmed and aggressive, with or without urothelial cancer.

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I am fully active or can carry out light work.

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I am healthy enough for cancer treatments like chemotherapy, immunotherapy, and surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received treatment for small-cell bladder cancer before.

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I have had a previous transplant of stem cells or an organ.

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I am currently on medication for hepatitis B.

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My cancer has spread to my brain or its coverings.

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I haven't had major heart problems in the last 3 months.

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I have not received a live vaccine in the last 4 weeks.

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I have high calcium levels in my blood that are causing symptoms.

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I have lung conditions or signs of lung inflammation on a recent chest scan.

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I have active tuberculosis.

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I have had chemotherapy for bladder cancer before.

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I have been treated with immune checkpoint inhibitors before.

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I have cancer in the upper part of my urinary system.

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I have another cancer besides non-melanoma skin cancer or prostate cancer.

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I have pain from my cancer that isn't managed well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic complete response (ypCR) at cystectomy

Secondary study objectives

1-year overall survival rate (1-yr OS)

2-year overall survival rate (2-yr OS)

Disease Free Survival

+4 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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

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

1Treatment groups

Experimental Treatment

Group I: Atezolizumab with Platinum and Etoposide, followed by cystectomy.Experimental Treatment5 Interventions

The study population will include male and female patients over the age of 18 with invasive (cT1-cT4) small cell / neuroendocrine carcinoma of the bladder (MIBC), with or without urothelial cancer component, who are eligible for platinum based chemotherapy and immunotherapy. All patients will be fit to undergo surgical resection of their cancer by cystectomy. Patients with resectable N1 disease within the true pelvis are eligible. Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg Day 1 of every 21 day cycle with chemotherapy x 4 cycles. Following cystectomy, Atezolizumab maintenance Q 21 days will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status (e.g., symptomatic deterioration such as pain secondary to disease), or up to 1 year (e.g., 16 cycles).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Carboplatin

2014

Completed Phase 3

~6120