Chemoradiotherapy + Atezolizumab for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+425 other locations

Overseen byParminder Singh

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

Research Team

Parminder Singh

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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.

Inclusion Criteria

Patients must be offered the opportunity to participate in specimen banking for future studies

I may or may not be a candidate for bladder removal surgery.

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

See 17 more

Exclusion Criteria

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

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.

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

See 15 more

Treatment Details

Interventions

Atezolizumab (Checkpoint Inhibitor)
Cisplatin (Alkylating agents)
Fluorouracil (Anti-metabolites)
Gemcitabine (Anti-metabolites)
Mitomycin (Anti-tumor antibiotic)
Radiation Therapy (Radiation)

Trial OverviewThe 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.

Participant Groups

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.

Cisplatin is already approved in Canada, Japan for the following indications: