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Alkylating agents

Chemoradiotherapy + Atezolizumab for Bladder Cancer

Phase 3

Waitlist Available

Led By Parminder Singh

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients who are known to be positive for human immunodeficiency virus (HIV) are eligible only if they have a stable regimen of highly active anti-retroviral therapy (HAART), no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections, a CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests within 28 days prior to randomization

Patients must have Zubrod performance status =< 2

Must not have

Patients must not have received a live, attenuated vaccine within 4 weeks prior to randomization or anticipate that such a live, attenuated vaccine will be required while on protocol treatment and up to 5 months after the last dose of protocol treatment

Patients must not have active autoimmune disease that has required systemic treatment in past two years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.

Who is the study for?

Adults with localized muscle invasive bladder cancer who've had a recent tumor removal and imaging, can participate. They must not have small cell carcinoma or certain other cancers in the last 24 months, no prior pelvic radiation or systemic chemotherapy for bladder cancer, and no severe liver disease or active infections. HIV-positive patients on stable treatment are eligible.

What is being tested?

The trial is testing if adding Atezolizumab (an immunotherapy drug) to standard chemoradiotherapy (using drugs like gemcitabine, cisplatin) improves outcomes in bladder cancer treatment. Patients will be randomly assigned to receive either the combination of treatments or just chemoradiotherapy.

What are the potential side effects?

Atezolizumab may cause immune-related reactions affecting organs, infusion reactions, fatigue; chemotherapy can lead to nausea, hair loss, blood disorders; radiation might result in skin irritation and fatigue. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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I am HIV positive, on stable HIV treatment, with no current infections, a CD4 count over 250, and an undetectable viral load.

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I can take care of myself but might not be able to do heavy physical work.

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I have mixed urothelial carcinoma but not small cell carcinoma.

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My bladder cancer is confirmed and untreated since diagnosis.

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I plan to follow a specific chemotherapy plan outlined in the study.

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I am 18 years old or older.

Exclusion Criteria

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

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I have not had a live vaccine in the last 4 weeks and won't need one during or up to 5 months after treatment.

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I haven't needed treatment for an autoimmune disease in the last two years.

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I haven't taken antibiotics for an infection in the last 14 days.

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My liver is healthy enough for cancer treatment.

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I have never had lung conditions like pulmonary fibrosis or pneumonitis.

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I have not had treatment for my current bladder cancer.

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I have not had any drug treatments for my early-stage bladder cancer.

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I have not had chemotherapy for my bladder cancer.

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I have never received radiation therapy to my pelvic area.

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I have not had a bone marrow or organ transplant.

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I have never had active tuberculosis.

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I have not had any other cancer types, except for certain exceptions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Bladder intact event-free survival (BI-EFS)

Secondary study objectives

Biopsy response

Complete response duration

Metastasis-free survival

+4 more

Other study objectives

Treatment interactions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (RT, chemotherapy, atezolizumab)Experimental Treatment13 Interventions

Patients undergo RT (3DCRT or IMRT) daily Monday-Friday for up to 7-8 weeks and receive chemotherapy based on physician's choice as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a TURBT with bladder biopsy at randomization and week 18 as well as cystoscopy at randomization, at weeks 18, 30, 42, 54, then every 3 months through year 2, followed by every 6months through year 5 and CT or MRI at randomization, at weeks 18, 30, 42, 54, then every 6 months through year 2, followed by every 12 months through year 5.

Group II: Arm I (RT, chemotherapy)Active Control12 Interventions

Patients undergo RT (3DCRT or IMRT) daily Monday-Friday for up to 7-8 weeks. Patients also receive chemotherapy based on physician's choice of gemcitabine IV twice weekly for 6 weeks concurrent with RT, or cisplatin IV weekly for 6 weeks concurrent with RT, or fluorouracil IV on same days as doses 1-5 and 16-20 of radiation therapy and mitomycin IV on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity. Patients also undergo a TURBT with bladder biopsy at randomization and week 18 as well as cystoscopy at randomization, at weeks 18, 30, 42, 54, then every 3 months through year 2, followed by every 6months through year 5 and CT or MRI at randomization, at weeks 18, 30, 42, 54, then every 6 months through year 2, followed by every 12 months through year 5.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cystoscopy

2016

Completed Phase 4

~810

Atezolizumab

2016

Completed Phase 3

~5860