475 Participants Needed

Chemoradiotherapy + Atezolizumab for Bladder Cancer

Recruiting at 426 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications like systemic chemotherapy, immunotherapy not specified in the protocol, and some vaccines are not allowed during the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the drug Atezolizumab when used with chemoradiotherapy for bladder cancer?

Research shows that combining platinum-based chemotherapy with radiation therapy can be effective for locally advanced bladder cancer, with a high rate of complete response and survival benefits. Neoadjuvant cisplatin-based chemotherapy has also been shown to improve survival in patients with metastatic bladder cancer, suggesting potential benefits when combined with other treatments like Atezolizumab.12345

Is the combination of chemoradiotherapy and atezolizumab safe for bladder cancer treatment?

The combination of chemoradiotherapy and atezolizumab for bladder cancer has been studied for safety. Atezolizumab is generally well-tolerated, even in patients with kidney issues, and is expected to work well with radiation therapy. Cisplatin, a component of chemoradiotherapy, can cause side effects like nausea and bone marrow suppression, but these are usually manageable.678910

What makes the treatment of chemoradiotherapy plus atezolizumab unique for bladder cancer?

This treatment combines chemoradiotherapy with atezolizumab, an immune therapy that helps the body's immune system attack cancer cells, offering a bladder-preserving option for patients who cannot undergo surgery. Atezolizumab is unique because it targets PD-L1, a protein that helps cancer cells evade the immune system, and is particularly beneficial for patients who are not eligible for traditional cisplatin chemotherapy.911121314

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

PS

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 16 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo radiation therapy and receive chemotherapy with or without atezolizumab

7-8 weeks
Daily visits Monday-Friday for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 3 months for 2 years, then every 6 months for 3 years

Treatment Details

Interventions

  • Atezolizumab
  • Cisplatin
  • Fluorouracil
  • Gemcitabine
  • Mitomycin
  • Radiation Therapy
Trial Overview 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.
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 European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
🇺🇸
Approved in United States as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
🇨🇦
Approved in Canada as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
🇯🇵
Approved in Japan as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

Combination chemotherapy for metastatic bladder cancer, particularly the MVAC regimen, shows the highest effectiveness with complete response rates of 30-40%.
Chemotherapy is primarily used for palliative care in metastatic cases, but it can also serve as neoadjuvant treatment to shrink tumors before surgery, potentially preserving the bladder.
[Why use chemotherapy in cancer of the bladder? What are the initial limitations].Maraninchi, D., Viens, P.[2013]
In a Phase II study involving patients with invasive bladder cancer, a combined treatment of cisplatin and radiotherapy resulted in a 66% complete remission rate, indicating its effectiveness in tumor clearance.
The treatment was generally well-tolerated, with only two patients unable to complete the therapy due to acute toxicity, suggesting a favorable safety profile for this regimen.
Combined modality program with possible organ preservation for invasive bladder carcinoma: results of RTOG protocol 85-12.Tester, W., Porter, A., Asbell, S., et al.[2019]
In a phase 2 study involving 45 patients with invasive bladder cancer, the combination of radiation therapy and atezolizumab resulted in a high pathologic complete response (pCR) rate of 84.4%, particularly in older patients and those with high PD-L1 expression.
The treatment was associated with acceptable toxicity, with 93.3% of patients experiencing adverse events, mostly mild to moderate, and only 13.3% experiencing grade 3 adverse events, indicating that this approach could be a viable bladder-preserving option.
Efficacy and Safety of Bladder Preservation Therapy in Combination with Atezolizumab and Radiation Therapy (BPT-ART) for Invasive Bladder Cancer: Interim Analysis from a Multicenter, Open-label, Prospective Phase 2 Trial.Kimura, T., Ishikawa, H., Nagumo, Y., et al.[2023]

References

Neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: a randomised controlled trial. International collaboration of trialists. [2022]
[Radiotherapy and chemotherapy in infiltrating bladder tumors]. [2006]
[Concurrent platinum-based chemotherapy and radiotherapy for locally advanced bladder cancer]. [2021]
[Why use chemotherapy in cancer of the bladder? What are the initial limitations]. [2013]
Neoadjuvant chemotherapy for bladder cancer. [2022]
Combined modality program with possible organ preservation for invasive bladder carcinoma: results of RTOG protocol 85-12. [2019]
A concomitant tumour boost in bladder irradiation: patient suitability and the potential of intensity-modulated radiotherapy. [2018]
Impact of Gemcitabine and Cisplatin with radiotherapy in locally advanced or metastatic transitional cell carcinoma of urinary bladder. [2022]
Bladder preservation therapy in combination with atezolizumab and radiation therapy for invasive bladder cancer (BPT-ART) - A study protocol for an open-label, phase II, multicenter study. [2021]
Phase II study of cis-diammine(glycolato)platinum, 254-S, in patients with advanced germ-cell testicular cancer, prostatic cancer, and transitional-cell carcinoma of the urinary tract. 254-S Urological Cancer Study Group. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Bladder Preservation Therapy in Combination with Atezolizumab and Radiation Therapy (BPT-ART) for Invasive Bladder Cancer: Interim Analysis from a Multicenter, Open-label, Prospective Phase 2 Trial. [2023]
Atezolizumab in invasive and metastatic urothelial carcinoma. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Nod for Atezolizumab in Advanced Bladder Cancer. [2018]
Systemic therapy in muscle-invasive and metastatic bladder cancer: current trends and future promises. [2017]
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