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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

IMAGINE Trial 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.Check my eligibility

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.See study design

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.

IMAGINE Trial 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.

IMAGINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

IMAGINE 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

~3870

Pembrolizumab

2017

Completed Phase 2

~2010

Nivolumab

2014

Completed Phase 3

~4750

Atezolizumab

2017

Completed Phase 3

~5860

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,635 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,664 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

Frequently Asked Questions

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

Has Pembrolizumab received official approval from the FDA?

"Pembrolizumab has undergone Phase 3 trials, so there is some data supporting efficacy and multiple rounds of data supporting safety. Consequently, our team at Power has given it a safety score of 3."

Answered by AI

What are the most common conditions that Pembrolizumab is used to treat?

"Pembrolizumab is commonly used to treat malignant neoplasms, and can also be effective in treating other conditions including unresectable melanoma, microsatellite instability high, and squamous cell carcinoma."

Answered by AI

Are there any other locations besides this state where the research is being conducted?

"To facilitate ease of access for potential participants, this clinical trial is enrolling patients at 100 sites. While Seattle, East Stroudsburg and Eau Claire are some of the locations, there are 100 other centres where this study is taking place."

Answered by AI

Are there other precedence for Pembrolizumab trials?

"Pembrolizumab was first studied in 2008 at UZ Gent. There have been698 completed studies since then. Pembrolizumab is presently being studied in 2467 live clinical trials, many of which are based in Seattle, Washington."

Answered by AI

To your knowledge, is this a new type of experiment?

"Pembrolizumab, which was first studied in 2008, has undergone extensive research with 2467 active studies in 79 different countries."

Answered by AI

Are people with the condition still able to sign up for the trial?

"That is correct, the most recent information available on clinicaltrials.gov points to this study as currently recruiting patients. The trial was first announced on December 10th, 2020 with a goal of recruiting 1038 patients from 100 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy

2020. "Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04637594.

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