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Immunotherapy Combinations for Bladder Cancer
Study Summary
This trial is designed to study new treatments for muscle-invasive bladder cancer (MIBC) and urothelial carcinoma (UC) that has progressed after a platinum-containing regimen. The study is flexible, meaning that new treatment arms can be added or existing ones closed based on activity or toxicity. Participants who do not respond to treatment in stage 1 may be eligible for a different regimen in stage 2.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT01005680Trial Design
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Who is running the clinical trial?
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- I can provide a sample of my tumor for PD-L1 and other tests.I agree to either not have sex or use birth control, and not donate sperm.My tumor can be biopsied.My blood and organs are functioning well.My cancer is in the urinary system and has spread.I am fully active or can carry out light work.My cancer got worse after one platinum-based treatment.
- Group 1: Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1)
- Group 2: Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2
- Group 3: Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2
- Group 4: Atezolizumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 1
- Group 5: Cisplatin-eligible MIBC Cohort 3 Arm 1
- Group 6: Cisplatin-eligible MIBC Cohort 3 Arm 2
- Group 7: Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2)
- Group 8: Atezolizumab + Tocilizumab for mUC Cohort (Stage 1)
- Group 9: Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2)
- Group 10: Atezolizumab + Magrolimab for mUC Cohort (Stage 1)
- Group 11: Atezolizumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 1
- Group 12: Atezolizumab for mUC Cohort (Stage 1)
- Group 13: Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1)
- Group 14: Atezolizumab + Niraparib for mUC Cohort (Stage 1)
- Group 15: Atezolizumab + Tiragolumab for mUC Cohort (Stage 1)
- Group 16: Atezolizumab + RO7122290 for mUC Cohort (Stage 1)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
How many individuals have signed up to participate in this research project?
"645 volunteers who fit the predefined eligibility requirements will be recruited for this study. Potential participants can find sites in Cleveland, Ohio and Louisville, Kentucky respectively at Cleveland Clinic and Norton Cancer Institute."
At what facilities can participants access this experiment?
"This research project is being implemented at 7 distinct medical sites, including those in Cleveland, Louisville and San Francisco. Prospective participants should prioritize selecting a trial centre that is geographically close to them as it will reduce travel burdens."
Are there any opportunities for individuals to participate in this experiment?
"According to clinicaltrials.gov, this medical study is still recruiting participants after being posted on June 1st 2019 and edited last November 1st 2022."
Are there any prior investigations that have made use of Hu5F9-G4?
"Presently, Hu5F9-G4 is the subject of 1478 clinical trials. Of these investigations, 414 are in Phase 3 while 73229 locations across Shanghai are running related studies."
What primary purpose does Hu5F9-G4 typically fulfill?
"Hu5F9-G4 is a drug used to treat neoplasm metastasis and other issues like bladder cancer, advanced testicular carcinoma, and small cell lung malignancy (SCLC)."
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