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Monoclonal Antibodies

Atezolizumab + Chemotherapy for Bladder Cancer

Phase 2

Waitlist Available

Led By Samuel Funt, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Histologically confirmed urothelial carcinoma of the bladder, ureter, urethra, or renal pelvis by the enrolling institution with a predominant urothelial component

Must not have

Prior treatment with anti-PD-1, anti-PD-L1 therapeutic antibody or pathway-targeting agents

Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of atezolizumab when given before or after standard chemotherapy drugs in patients with advanced bladder cancer.

Who is the study for?

Adults with advanced bladder cancer that can't be surgically removed or has spread, who haven't had chemotherapy or immunotherapy for metastatic disease. They must have a life expectancy of at least 12 weeks, measurable disease amenable to biopsy, and agree to use effective contraception post-treatment. Excluded are those with prior transplants, heart disease class III/IV, certain recent treatments including investigational drugs and systemic steroids, known liver diseases or bone marrow disorders, active infections like HIV/Hepatitis B/C/TB, severe allergies to specific antibodies or proteins.

What is being tested?

The trial is testing the effectiveness of Atezolizumab (an immune therapy drug) combined with Gemcitabine and Cisplatin (chemotherapy drugs) in two different sequences: one where chemotherapy is given before Atezolizumab and another where it's given after. The goal is to see which sequence works better against metastatic bladder cancer.

What are the potential side effects?

Atezolizumab may cause immune-related reactions affecting organs like lungs or intestines; infusion reactions; fatigue; skin issues; hormone gland problems such as thyroid disorders. Chemotherapy with Gemcitabine and Cisplatin can lead to blood cell count changes increasing infection risk; kidney damage; nausea/vomiting.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My cancer is confirmed to be mainly urothelial and affects my bladder, ureter, urethra, or renal pelvis.

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My cancer is advanced or has spread to other parts of my body.

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I am 18 years old or older.

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My cancer can be measured and biopsied according to specific guidelines.

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I agree to have two biopsies for research during my treatment.

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I have enough tumor tissue available for PD-L1 testing.

Exclusion Criteria

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

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I have been treated with drugs targeting PD-1 or PD-L1.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I have had a bone marrow or organ transplant in the past.

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I have a brain tumor or cancer that has spread to my brain and causes symptoms.

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My heart condition severely limits my daily activities.

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I have moderate to severe numbness, tingling, or muscle weakness.

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I have moderate to severe hearing loss.

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I have a history of lung scarring or inflammation.

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I have a bone marrow disorder that may affect my treatment.

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I have not had major surgery in the last 28 days.

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

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I have a history of HIV or active hepatitis B or C.

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I have not had signs of infection in the last 2 weeks.

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I have taken antibiotics by mouth or IV within the last 2 weeks.

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I have active tuberculosis.

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I am taking bisphosphonates for high calcium levels.

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I have a serious liver condition.

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I have had chemotherapy or immunotherapy for bladder cancer that has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

overall response rate

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

Dysgeusia

Headache

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

3Treatment groups

Experimental Treatment

Group I: Atezolizumab with Gemcitabine and CisplatinExperimental Treatment3 Interventions

Gemcitabine and Cisplatin for 2 cycles. One treatment cycle equals 21 days. After 2 cycles of Gemcitabine and Cisplatin patient will receive combined atezolizumab and Gemcitabine and Cisplatin for 4 cycles. All 6 treatment cycles will take approximately 18 weeks. If carboplatin is substituted for cisplatin, eGFR for dosing may be calculated by institutional standard formulas, at the discretion of the treating investigator.

Group II: Atezolizumab alone with Gemcitabine and CisplatinExperimental Treatment3 Interventions

Atezolizumab alone for 2 cycles. One treatment cycle equals 21 days. Then patient will receive combined atezolizumab and Gemcitabine and Cisplatin for 6 cycles. All 8 treatment cycles will take approximately 24 weeks. If carboplatin is substituted for cisplatin, eGFR for dosing may be calculated by institutional standard formulas, at the discretion of the treating investigator. This cohort is NO LONGER ACCRUING patients since 5/22/2018.

Group III: Atezolizumab alone for 1 cycle prior to gemcitabine, cisplatinExperimental Treatment3 Interventions

Atezolizumab alone for 1 cycle. One treatment cycle equals 21 days. After 1 cycle of atezolizumab the patients will receive combined atezolizumab and gemcitabine, cisplatin for 4 cycles. All 5 treatment cycles will take approximately 15 weeks. Cisplatin dose can be given on day 1 or split over days 1 and 8 at the investigator"s discretion. Once the split-dose cisplatin is used, it should be used for the remainder of the chemotherapy treatment course.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Gemcitabine

2017

Completed Phase 3

~1920