Atezolizumab +/− Eribulin Mesylate for Bladder Cancer

Not currently recruiting at 21 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, Immunostimulants

Disqualifiers: Organ transplant, Autoimmune disease, Cardiovascular disease, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 24

Duration: Up to 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, atezolizumab and eribulin mesylate, to evaluate their effectiveness against bladder cancer that has returned or spread. Atezolizumab, an immunotherapy, helps the immune system target cancer, while eribulin mesylate, a chemotherapy, stops cancer cells from growing and spreading. The trial compares the combination of both drugs to atezolizumab alone. It seeks participants with bladder cancer that has spread or recurred, particularly those who have previously undergone treatments like chemotherapy but continue to face the disease. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like systemic immunosuppressive medications and some investigational agents must be stopped before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that atezolizumab, a type of immunotherapy, is generally well-tolerated by patients with bladder cancer. Studies have found that it can significantly improve survival rates. Specifically, one study found that this treatment lowered the risk of death by 41% compared to a placebo. While side effects may occur, many patients can manage them.

Combining atezolizumab with eribulin mesylate might lead to better treatment outcomes. However, adding eribulin mesylate could also increase the chance of side effects. Researchers are still studying this combination to fully understand its safety. Patients should discuss the potential risks and benefits with their healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of atezolizumab and eribulin mesylate for bladder cancer because it offers a fresh approach to treatment. Atezolizumab is an immunotherapy that boosts the body's immune system to fight cancer cells, which is different from traditional chemotherapy that directly attacks the cells. Eribulin mesylate, typically used for breast cancer, is being tested here for its unique mechanism of interfering with cancer cell division. This combination could potentially provide a more effective treatment option by harnessing both immune system activation and direct cancer cell disruption, offering hope for improved outcomes in bladder cancer patients.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

Studies have shown that atezolizumab, which participants in this trial may receive, effectively treats patients with advanced bladder cancer. It has extended patients' lives and slowed cancer progression. This trial will also test a combination of atezolizumab with eribulin mesylate in a separate treatment arm. Research suggests that this combination might be even more effective for bladder cancer. Atezolizumab helps the immune system attack cancer, while eribulin mesylate stops cancer cells from growing and spreading. Early findings indicate this combination could outperform atezolizumab alone. ^{2 3 6 7 8}

Who Is on the Research Team?

Anishka D'Souza

Principal Investigator

City of Hope Comprehensive Cancer Center LAO

Are You a Good Fit for This Trial?

Adults over 18 with recurrent, locally advanced or metastatic urothelial cancer who've had platinum-based treatment within the last year. They must have recovered from previous treatments' side effects, have a life expectancy of at least 12 weeks, and measurable disease. HIV-positive patients can join if they meet certain criteria. Exclusions include autoimmune diseases, severe heart or liver conditions, recent major surgery or vaccinations, current serious infections, history of lung problems like pneumonitis, and prior bone marrow or organ transplants.

Inclusion Criteria

My cancer is advanced and cannot be removed by surgery.

I can provide a sample of my tumor for testing.

My cancer came back or got worse within a year after platinum-based treatment.

Exclusion Criteria

I do not have any unmanaged ongoing illnesses.

I have had a bone marrow or organ transplant.

I have recently undergone chemotherapy, radiotherapy, or targeted therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive atezolizumab with or without eribulin mesylate in 21-day cycles

Up to 52 weeks

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Every 3 or 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Eribulin Mesylate

Trial Overview The trial is testing how well Atezolizumab works alone versus combined with Eribulin Mesylate in treating urothelial cancer that has returned after treatment or spread to other parts of the body. Atezolizumab is an immunotherapy drug while Eribulin Mesylate is a chemotherapy drug; both aim to stop cancer growth by different mechanisms.

How Is the Trial Designed?

Group I: Arm II (atezolizumab, eribulin mesylate) Experimental Treatment 5 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle and eribulin mesylate IV over 2-3 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and CT with contrast throughout the trial. Patients may undergo biopsy during screening and on study.

Group II: Arm I (atezolizumab) Experimental Treatment 4 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and CT with contrast throughout the trial. Patients may undergo biopsy during screening and on study.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 115 patients with metastatic urothelial carcinoma treated with atezolizumab (ATZ) after failing first-line chemotherapy, the objective response rate was 28.7%, indicating that ATZ is effective in this patient population.

The treatment was well tolerated, with 98% of patients experiencing adverse events, but only 21.2% had severe (grade 3-4) treatment-related adverse events, suggesting a manageable safety profile similar to previous clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences. Tural, D., Ölmez, ÖF., Sümbül, AT., et al.[2022]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

Atezolizumab, an anti-PD-L1 monoclonal antibody, has shown durable responses in treating locally advanced and metastatic urothelial cancer, especially in patients who have failed platinum-based chemotherapy or are ineligible for cisplatin.

The treatment with atezolizumab has a more favorable toxicity profile compared to traditional cytotoxic chemotherapy, making it a promising option for patients with advanced bladder cancer, although further research is needed to identify additional predictive markers for response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab in invasive and metastatic urothelial carcinoma. Crist, M., Balar, A.[2019]

Atezolizumab, a monoclonal antibody targeting PD-L1, showed a 23% response rate and a median overall survival of 15.9 months in 119 patients with metastatic urothelial cancer who were unfit for cisplatin, indicating its efficacy as a front-line treatment.

In patients whose tumors progressed after first-line chemotherapy, atezolizumab had a 15% response rate and a median overall survival of 7.9 months, with better outcomes (26% response rate) in those with high PD-L1 expression, demonstrating its potential effectiveness based on biomarker status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. Bernard-Tessier, A., Bonnet, C., Lavaud, P., et al.[2019]

Citations

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Efficacy and safety of atezolizumab in the treatment ... Atezolizumab has demonstrated significant improvements in OS and PFS among patients with UC, offering crucial insights for decision-making in UC immunotherapy.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37537512/

Outcomes with atezolizumab in metastatic urothelial cancer In this retrospective study, atezolizumab was an effective and tolerable treatment option for patients with mUC after progression to platinum-based ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456920302698

Atezolizumab in Patients with Metastatic Urothelial ... Atezolizumab is effective and well-tolerated in patients with metastatic urothelial cancer who progressed with first-line chemotherapy.

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ctDNA-Guided Adjuvant Atezolizumab in Muscle-Invasive ... Among 357 patients with persistent ctDNA-negative status, disease-free survival was 95% at the end of the 1-year monitoring period and 88% at 2 ...

5. esmoopen.com esmoopen.com/article/S2059-7029(24)01742-3/fulltext

final analysis from the phase II IMvigor210 trial These final long-term data show that atezolizumab provides durable clinical benefit to a subset of patients with mUC. Abstract. Background. The ...

6. roche.com roche.com/media/releases/med-cor-2025-10-20b

Roche's Tecentriq showed significant overall and disease- ... Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placebo1; IMvigor011 is the ...

7. gene.com gene.com/media/press-releases/15084/2025-10-19/genentechs-tecentriq-showed-significant-

Genentech: Press Releases | Sunday, Oct 19, 2025 Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placebo.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02792192

Study Details | NCT02792192 | Safety and Pharmacology ... This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary ...