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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune or inflammatory disorder but don't need more than 10 mg/day of prednisone.I don't have tuberculosis, hepatitis B or C, or uncontrolled HIV.I have had hepatitis C but my current tests show no active virus.I had hepatitis B but it's no longer active.My cancer is in the bladder, renal pelvis, ureter, urethra, or prostate.My cancer is advanced but has not been treated with immune therapy yet.I am not taking more than 10 mg/day of prednisone or any similar medication.I have no other cancers except possibly skin cancer or early-stage cervical cancer treated over 2 years ago.I am not pregnant or breastfeeding and willing to use birth control.I have undergone at least one treatment cycle with an FDA-approved immunotherapy for my advanced or metastatic bladder cancer.My cancer hasn't worsened after 12-15 months of immunotherapy.My cancer is confirmed to be urothelial carcinoma with mainly transitional-cell features.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (immune checkpoint inhibitor)
- Group 2: Arm A (immune checkpoint inhibitor)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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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