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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months, and 18 months
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 12 months, and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months, and 18 months
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 moreTrial 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 3
~1000
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,091,395 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-LaRoche
2,204 Previous Clinical Trials
890,066 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high calcium levels in my blood that are causing symptoms.I have had lung conditions like pulmonary fibrosis or pneumonitis, or my CT scan shows active pneumonitis.My kidney function is very low.I have had a previous transplant of stem cells or an organ.I haven't taken any experimental drugs recently.I have not taken antibiotics for treatment, only for prevention, in the last 2 weeks.I have or had an autoimmune disease or immune deficiency.I frequently need procedures to remove excess fluid from my chest or abdomen.I am currently on medication for hepatitis B.My blood and organs are functioning well.My heart is healthy and functions well.I have had cancer spread to the lining of my brain and spinal cord.I have not been treated with specific immune therapies like CD137 agonists or anti-TIGIT.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.I haven't had a heart or stroke issue in the last 3 months.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I have not had a severe infection in the last 4 weeks.I do not have active tuberculosis or a recent Epstein-Barr virus infection.I have not had chemotherapy for my advanced or recurrent bladder cancer.I haven't had a live vaccine recently and don't plan to during or soon after treatment.My cancer is a type of bladder cancer that has spread and includes urothelial cells.I have pain from my cancer that isn't managed well.I have brain metastases that are untreated or getting worse.I have not had cancer other than bladder cancer in the last 2 years, except for very low-risk types.I haven't had cancer treatment, including chemo or hormonal therapy, in the last 3 weeks.I cannot receive platinum-based chemotherapy due to health reasons.I have a leftover tumor sample available for PD-L1 testing.I can perform daily activities with minimal assistance.I haven't taken immune-boosting drugs in the last 4 weeks or 5 half-lives.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm C
- Group 3: Arm A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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