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PD-L1 Inhibitor

Immunotherapy for Bladder Cancer

Phase 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium. Participants with squamous, sarcomatoid, micropapillary, and glandular variant histologies are eligible for inclusion in the study, provided that a urothelial component is present in the tumor specimen. Participants with other variant histologies or pure variant histologies are not eligible for inclusion in this study
Ineligible ('unfit') to receive platinum-based chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months, and 18 months
Awards & highlights

Study Summary

This trial looks at new treatments for people with advanced urothelial cancer who can't take chemotherapy.

Who is the study for?
This trial is for adults with advanced bladder cancer who haven't had treatment yet and can't have platinum chemotherapy. They should be relatively active (ECOG ≤ 2), not pregnant, without serious heart or kidney issues, no recent major surgeries, and free from certain infections like hepatitis B/C and tuberculosis.Check my eligibility
What is being tested?
The study tests the effectiveness of Tobemstomig alone or with Tiragolumab versus Atezolizumab in untreated metastatic urothelial cancer patients. It aims to see which combination works best for those who can't receive standard chemo.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect organs, infusion reactions similar to allergic responses, fatigue, potential lung problems like pneumonitis, as well as an increased risk of infections due to a weakened immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of bladder cancer that has spread and includes urothelial cells.
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I cannot receive platinum-based chemotherapy due to health reasons.
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I have not had chemotherapy for my advanced or recurrent bladder cancer.
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I can perform daily activities with minimal assistance.
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I have a leftover tumor sample available for PD-L1 testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed Objective Response Rate (ORR)
Secondary outcome measures
Area Under the Curve (AUC) of Tobemstomig
Change from Baseline in European Organisation for Research and Cancer Treatment Item Library 187 (EORTC IL 187) Scores
Clearance (CL) of Tobemstomig
+16 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm CExperimental Treatment2 Interventions
Participants will receive IV tobemstomig + IV tiragolumab Q3W.
Group II: Arm BExperimental Treatment1 Intervention
Participants will receive IV tobemstomig Q3W.
Group III: Arm AActive Control1 Intervention
Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiragolumab
2020
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,814 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-LaRoche
2,199 Previous Clinical Trials
888,262 Total Patients Enrolled

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05645692 — Phase 2
Bladder Cancer Research Study Groups: Arm B, Arm C, Arm A
Bladder Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05645692 — Phase 2
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05645692 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree do the risks of Arm B outweigh its potential benefits?

"Due to its Phase 2 status, Arm B was assigned a score of two on our safety scale as there is evidence for the drug's security but not yet any data backing up efficacy."

Answered by AI

Is this research currently accessible to potential participants?

"Correct. According to the data accessible on clinicaltrials.gov, this medical trial which was initially posted on April 13th 2023 is actively seeking participants. A total of 240 patients are needed from 31 different sites for enrollment in the study."

Answered by AI

In which geographic areas is this experiment being conducted?

"Numerous medical centres have recruited patients for this trial, including Advent Health Orlando in Orlando, SCRI Mark H. Zangmeister Center in Columbus and the Tennessee Oncology Chattanooga site in Chattanooga. Altogether 31 sites are actively recruiting participants."

Answered by AI

How many participants are actively engaging in the experiment?

"Affirmative. According to the clinicaltrials.gov registry, this scientific trial started accepting applicants on April 13th 2023 and is still actively seeking participants. There are 31 sites across the country participating in this study, which requires 240 patients for completion."

Answered by AI
~160 spots leftby Dec 2026