Tiragolumab + Atezolizumab for Bladder Cancer

Overseen By Padmanee Sharma, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antibiotics, Immunosuppressants, Immunostimulants

Disqualifiers: Autoimmune disease, Cardiovascular disease, others

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining atezolizumab (an immunotherapy drug) and tiragolumab (an experimental treatment) can help control bladder cancer when administered before surgery. Researchers seek to discover if these drugs can shrink the cancer or make it easier to remove. The trial targets individuals with muscle-invasive bladder cancer who are ineligible for or have declined standard chemotherapy. Participants must have recently undergone bladder surgery (TURBT) and be eligible for curative surgery. This trial offers an opportunity for those needing more options before bladder removal surgery. As a Phase 1, Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, providing participants a chance to explore new treatment possibilities.

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, if you are on systemic immunosuppressive medication or certain other treatments, you may need to stop them 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 and tiragolumab are generally safe. Atezolizumab, tested in people with bladder cancer, helped them live longer and was usually well-tolerated, with most side effects being mild and manageable.

For tiragolumab, one study with patients who had various solid tumors found that only 4% experienced severe side effects. When combined with atezolizumab, tiragolumab was also well-tolerated, with no major issues in drug handling by the body.

Both treatments have undergone thorough testing, indicating general safety, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Tiragolumab and Atezolizumab for bladder cancer because it introduces a novel approach to treatment. Unlike traditional therapies, which often target cancer cells directly, this combination enhances the body's immune response against cancer. Atezolizumab is a PD-L1 inhibitor that helps immune cells recognize and attack cancer cells, while Tiragolumab targets TIGIT, another pathway that tumors use to evade the immune system. This dual-targeting strategy could potentially lead to more effective and durable responses compared to existing treatments.

What evidence suggests that the combination of atezolizumab and tiragolumab could be effective for bladder cancer?

Research shows that atezolizumab, one of the treatments in this trial, offers significant benefits for people with bladder cancer. Studies have found that it can reduce the risk of death by up to 41% and decrease the chance of cancer recurrence by 36%. Atezolizumab also benefits patients with advanced bladder cancer who did not respond well to initial treatments.

Tiragolumab, another treatment option in this trial, is under study for its potential to help the immune system fight cancer. Early trials suggest it is safe and may work well with atezolizumab. Together, these treatments could provide a promising approach to managing bladder cancer before surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Padmanee Sharma, MD, PhD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with high-risk urothelial carcinoma who can't take cisplatin or refused it, and are fit enough for bladder surgery. They must have good lung function, no severe infections or recent major surgeries, not be on certain medications, and agree to use contraception if applicable. People with active TB, certain heart conditions, other cancers within 5 years, or autoimmune diseases cannot join.

Inclusion Criteria

I am eligible for a surgery aimed at completely removing my cancer.

Negative hepatitis B surface antigen (HBsAg) test at screening

Ability to comply with the study protocol

Exclusion Criteria

I have had a previous transplant of stem cells or an organ.

Treatment with investigational therapy within 42 days prior to study treatment

History of severe allergic anaphylactic reactions to specific agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant treatment with atezolizumab and tiragolumab

6 weeks

3 visits (in-person)

Surgery

Participants undergo surgery to remove the bladder and tumor

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab and Tiragolumab

Trial Overview The study tests whether combining two drugs (Tiragolumab and Atezolizumab) before surgery can better control bladder cancer compared to current treatments. Participants will receive these drugs prior to their planned surgical procedure to remove the tumor.

How Is the Trial Designed?

Group I: Tiragolumab Experimental Treatment 1 Intervention

Tiragolumab will be administered at a fixed dose of 600 mg intravenously Q3W on Day 1 of each 21-day cycle.

Group II: Atezolizumab Experimental Treatment 1 Intervention

Atezolizumab will be administered at a fixed dose of 1200 mg Q3W (1200 mg on Day 1 of each 21 day cycle),

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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]

Atezolizumab has been approved by the FDA as a treatment for advanced bladder cancer, specifically for patients who cannot receive cisplatin chemotherapy.

This approval provides a potentially more effective treatment option compared to carboplatin-based chemotherapy, particularly for frail and elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nod for Atezolizumab in Advanced Bladder Cancer. [2018]

Atezolizumab, an anti-PD-L1 therapy, showed long-term safety and efficacy in patients with metastatic urothelial carcinoma, with a median follow-up of 37.8 months and a low incidence of severe treatment-related adverse events (9%).

The treatment resulted in a 26% objective response rate, with a median duration of response of 22.1 months, and median overall survival of 10.1 months, particularly benefiting patients with higher PD-L1 expression on immune cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. Petrylak, DP., Powles, T., Bellmunt, J., et al.[2022]

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, 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 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]

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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 ...

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Real-world data of atezolizumab in patients with previously ... Conclusion: In a real-world population with previously treated mUBC, atezolizumab seems to provide clinically relevant benefit, which is even ...

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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.

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ctDNA-Guided Adjuvant Atezolizumab Boosts DFS, OS in ... Additionally, ctDNA-positive patients in the atezolizumab arm experienced a median OS of 32.8 months (95% CI, 27.7-not evaluable [NE]) compared ...