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Checkpoint Inhibitor

Immune Checkpoint Therapy Duration for Bladder Cancer (IMAGINE Trial)

Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor Site: Bladder, renal pelvis, ureter, urethra, or prostate
Stage: Locally advanced or metastatic disease prior to starting immune checkpoint blockade
Must not have
No history of tuberculosis, active hepatitis B (HBV) or hepatitis C (HCV), or uncontrolled human immunodeficiency virus (HIV)
Patients with positive HCV antibody are eligible if HCV ribonucleic acid (RNA) polymerase chain reaction (PCR) is negative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is comparing the benefits of continuing versus stopping immunotherapy treatment for urothelial cancer patients.

Who is the study for?
This trial is for adults with urothelial carcinoma, a type of bladder cancer. Participants must have had at least one cycle of FDA-approved immune therapy and not show disease progression after 12-15 months of treatment. They can't join if they're pregnant, breastfeeding, unwilling to use birth control, or have certain infections or a history of other cancers.
What is being tested?
The study compares the effects of stopping immune checkpoint inhibitors (avelumab, durvalumab, pembrolizumab, nivolumab, atezolizumab) after about a year versus continuing them. It aims to see if early discontinuation affects survival rates while reducing side effects and costs.
What are the potential side effects?
Side effects from these drugs may include fatigue, skin reactions, inflammation in organs like lungs or intestines (which might cause coughing or diarrhea), hormonal gland problems (like thyroid issues), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in the bladder, renal pelvis, ureter, urethra, or prostate.
Select...
My cancer is advanced but has not been treated with immune therapy yet.
Select...
I have undergone at least one treatment cycle with an FDA-approved immunotherapy for my advanced or metastatic bladder cancer.
Select...
My cancer hasn't worsened after 12-15 months of immunotherapy.
Select...
My cancer is confirmed to be urothelial carcinoma with mainly transitional-cell features.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have tuberculosis, hepatitis B or C, or uncontrolled HIV.
Select...
I have had hepatitis C but my current tests show no active virus.
Select...
I am not taking more than 10 mg/day of prednisone or any similar medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Immune-related progression-free survival (iPFS)
Incidence of adverse events (AEs)
Progression-free survival (PFS)
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (immune checkpoint inhibitor)Experimental Treatment5 Interventions
DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.
Group II: Arm A (immune checkpoint inhibitor)Active Control5 Interventions
CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Durvalumab
2017
Completed Phase 2
~3840
Pembrolizumab
2017
Completed Phase 2
~2010
Nivolumab
2014
Completed Phase 3
~4740
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,623 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,398 Total Patients Enrolled
Xiao X. Wei, MD, MASStudy ChairDana-Farber Cancer Institute

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04637594 — Phase 3
Urothelial Carcinoma Research Study Groups: Arm B (immune checkpoint inhibitor), Arm A (immune checkpoint inhibitor)
Urothelial Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04637594 — Phase 3
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04637594 — Phase 3
~1 spots leftby Jul 2026
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