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Checkpoint Inhibitor

Immunotherapy Combinations for Bladder Cancer

Phase 1 & 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
Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5-7 years) as determined by the investigator according to recist 1.1
Awards & highlights

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.

Who is the study for?
This trial is for adults with advanced bladder cancer who've had disease progression after one platinum-based treatment. They must be in good physical condition, have proper organ function, and not have HIV or hepatitis. A tumor sample for testing and measurable disease are required. Participants need to agree to use birth control methods.Check my eligibility
What is being tested?
The study tests multiple immunotherapy drugs (like Atezolizumab) and combinations on bladder cancer that's spread or can't be removed by surgery. It adapts over time, introducing new treatments and removing those less effective or too harmful.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion reactions from the drugs being given through veins, fatigue, blood disorders like anemia or clotting issues, increased risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a sample of my tumor for PD-L1 and other tests.
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I agree to either not have sex or use birth control, and not donate sperm.
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My tumor can be biopsied.
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My blood and organs are functioning well.
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My cancer is in the urinary system and has spread.
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I am fully active or can carry out light work.
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My cancer got worse after one platinum-based treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5-7 years) as determined by the investigator according to recist 1.1
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5-7 years) as determined by the investigator according to recist 1.1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) for mUC Cohort Stage 1
pCR for Muscle Invasive Bladder Cancer (MIBC) Cohorts
Secondary outcome measures
Disease Control Rate (DCR) for mUC Cohort Stage 1
Duration of Response (DOR) for mUC Cohort Stage 1
Landmark Event-Free Survival (EFS) for MIBC Cohorts
+12 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

16Treatment groups
Experimental Treatment
Active Control
Group I: Cisplatin-eligible MIBC Cohort 3 Arm 2Experimental Treatment4 Interventions
Participants will receive Atezolizumab, Tiragolumab (Tira), Cisplatin and Gemcitabine for 3 cycles pre-surgery and 14 cycles of Atezolizumab and Tiragolumab (Tira) post-surgery.
Group II: Atezolizumab + Tocilizumab for mUC Cohort (Stage 1)Experimental Treatment2 Interventions
Participants will receive atezolizumab and Tocilizumab (TCZ) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Group III: Atezolizumab + Tiragolumab for mUC Cohort (Stage 1)Experimental Treatment2 Interventions
Participants will receive atezolizumab and Tiragolumab (Tira) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Group IV: Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2Experimental Treatment2 Interventions
Participants will receive Atezolizumab and Tiragolumab (Tira) for 3 cycles pre-surgery and 14 cycles post-surgery.
Group V: Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2Experimental Treatment2 Interventions
Participants will receive Atezolizumab and Tiragolumab (Tira) for 3 cycles pre-surgery and 14 cycles post-surgery.
Group VI: Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2)Experimental Treatment2 Interventions
Participants will receive atezolizumab and Sacituzumab Govitecan (SG) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Group VII: Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1)Experimental Treatment2 Interventions
Participants will receive atezolizumab and Sacituzumab Govitecan (SG) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Group VIII: Atezolizumab + RO7122290 for mUC Cohort (Stage 1)Experimental Treatment1 Intervention
Participants will receive atezolizumab and RO7122290 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Group IX: Atezolizumab + Niraparib for mUC Cohort (Stage 1)Experimental Treatment2 Interventions
Participants will receive atezolizumab and Niraparib (Nira) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Group X: Atezolizumab + Magrolimab for mUC Cohort (Stage 1)Experimental Treatment2 Interventions
Participants will receive atezolizumab and magrolimab (Hu5F9-G4) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Group XI: Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2)Experimental Treatment2 Interventions
Participants will receive atezolizumab and Enfortumab Vedotin (EV) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Group XII: Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1)Experimental Treatment2 Interventions
Participants will receive atezolizumab and Enfortumab Vedotin (EV) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Group XIII: Cisplatin-eligible MIBC Cohort 3 Arm 1Active Control3 Interventions
Participants will receive 3 cycles of Atezolizumab, Cisplatin, and Gemcitabine pre-surgery and 14 cycles of Atezolizumab only post-surgery.
Group XIV: Atezolizumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 1Active Control1 Intervention
Participants will receive Atezolizumab for 3 cycles pre-surgery and 14 cycles post-surgery.
Group XV: Atezolizumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 1Active Control1 Intervention
Participants will receive Atezolizumab for 3 cycles pre-surgery and 14 cycles post-surgery.
Group XVI: Atezolizumab for mUC Cohort (Stage 1)Active Control1 Intervention
Participants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840
Atezolizumab
2017
Completed Phase 3
~5860
Gemcitabine
2017
Completed Phase 3
~2070
Tiragolumab
2020
Completed Phase 2
~350
Cisplatin
2013
Completed Phase 3
~1940
Niraparib
2018
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

Gilead Sciences, Inc., GlaxoSmithKline plc, Seattle Genetics and AstellasUNKNOWN
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,409 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03869190 — Phase 1 & 2
Bladder Cancer Research Study Groups: Atezolizumab + Magrolimab for mUC Cohort (Stage 1), Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1), Cisplatin-eligible MIBC Cohort 3 Arm 1, Atezolizumab + Tocilizumab for mUC Cohort (Stage 1), Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2, Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2), Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2, Atezolizumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 1, Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2), Cisplatin-eligible MIBC Cohort 3 Arm 2, Atezolizumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 1, Atezolizumab for mUC Cohort (Stage 1), Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1), Atezolizumab + Niraparib for mUC Cohort (Stage 1), Atezolizumab + Tiragolumab for mUC Cohort (Stage 1), Atezolizumab + RO7122290 for mUC Cohort (Stage 1)
Bladder Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03869190 — Phase 1 & 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03869190 — Phase 1 & 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
2019. "Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03869190.
~68 spots leftby Dec 2024
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