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Checkpoint Inhibitor

Immunotherapy Combinations for Bladder Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Tumor accessible for biopsy

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

No Placebo-Only Group

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.

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.

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 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 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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) for mUC Cohort Stage 1

pCR for Muscle Invasive Bladder Cancer (MIBC) Cohorts

Secondary study objectives

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

+6 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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Dyspnoea

Cerebral infarction

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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

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

Gemcitabine

2017

Completed Phase 3

~1920

Atezolizumab

2016

Completed Phase 3

~5860