Immune Checkpoint Therapy Duration for Bladder Cancer
(IMAGINE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether people with urothelial cancer (a type of bladder cancer) can stop immunotherapy early and still maintain the same survival rates as those who continue. Researchers aim to determine if stopping treatment after about a year can still shrink the tumor while reducing side effects, improving mental health, and lowering costs. The trial involves treatments with monoclonal antibodies like atezolizumab (Tecentriq) and pembrolizumab (KEYTRUDA), which help the immune system fight cancer. This trial might suit someone who has been on one of these treatments for 12-15 months, with stable or improved cancer, and no severe side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on immunosuppressive medication exceeding 10 mg/day of prednisone or its equivalent.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that treatments like nivolumab, used in immune checkpoint therapy for bladder cancer, have generally been well-tolerated by patients in past studies. Common side effects include fatigue, muscle aches, nausea, and reduced appetite. More serious side effects, such as lung disease or pneumonia, have been reported but occur in only a small percentage of patients.
The FDA has already approved nivolumab for treating urinary tract cancers, indicating a certain level of confidence in its safety for this type of cancer. This approval provides extra reassurance about its use in these treatments.
For the other treatments in this trial—atezolizumab, avelumab, durvalumab, and pembrolizumab—similar drugs have demonstrated similar safety profiles in past research. Generally, stopping these treatments early may reduce side effects, improve mental health, and lower costs without affecting patient survival.12345Why are researchers excited about this trial's treatments?
Researchers are excited about immune checkpoint inhibitors like atezolizumab, avelumab, durvalumab, nivolumab, and pembrolizumab because they offer a novel approach to treating bladder cancer by harnessing the body's immune system to fight cancer cells. Unlike traditional chemotherapy, which directly targets and kills cancer cells, these treatments work by blocking proteins that prevent the immune system from attacking tumors. This can potentially lead to more durable and long-lasting responses. Moreover, the ability to discontinue and then restart treatment at signs of disease progression adds a flexible dynamic not typical of conventional therapies, offering hope for improved management of the condition.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Research shows that drugs called immune checkpoint inhibitors, such as nivolumab, can effectively treat urothelial cancer. In this trial, participants in Arm A will continue receiving immune checkpoint inhibitors like nivolumab, while those in Arm B will discontinue treatment. One study found that patients with upper tract urothelial carcinoma who took nivolumab had a 73.1% chance of remaining cancer-free and an 85.1% chance of overall survival after two years. This indicates that nivolumab can significantly reduce the risk of cancer recurrence. Additionally, those treated with nivolumab had a 30% lower chance of cancer returning compared to those who received a placebo. These results suggest that immune checkpoint inhibitors might enhance the body's ability to fight and control bladder cancer.678910
Who Is on the Research Team?
Xiao X. Wei, MD, MAS
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive immune checkpoint inhibitors such as pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab. Treatment cycles repeat every 21 to 42 days depending on the specific drug regimen.
Follow-up
Participants are monitored for overall survival, progression-free survival, and adverse events after treatment completion.
Treatment-free Interval (Arm B)
Participants in Arm B discontinue ICI treatment and may restart upon disease progression at physician discretion.
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Avelumab
- Durvalumab
- Nivolumab
- Pembrolizumab
Atezolizumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator