Immune Checkpoint Therapy Duration for Bladder Cancer
(IMAGINE Trial)
Trial Summary
What is the purpose of this trial?
This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab, pembrolizumab, atezolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.
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.
What data supports the effectiveness of the drug Atezolizumab for bladder cancer?
Atezolizumab has been shown to be effective in treating advanced bladder cancer, with a 15% response rate in patients whose cancer progressed after chemotherapy and a 24% response rate in those who were chemotherapy-naïve. It also improved 1-year survival rates to 36% and 57% in these groups, respectively, compared to historical treatments.12345
Is immune checkpoint therapy, like Atezolizumab, generally safe for humans?
How is immune checkpoint therapy with drugs like Atezolizumab different for bladder cancer?
Immune checkpoint therapy drugs like Atezolizumab are unique because they block proteins that prevent the immune system from attacking cancer cells, specifically targeting the PD-L1/PD-1 pathway to boost the body's immune response against bladder cancer. This approach has shown better response rates and survival compared to traditional chemotherapy, especially in patients who have not responded to first-line treatments.13469
Research Team
Xiao X. Wei, MD, MAS
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
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
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.
Treatment Details
Interventions
- Atezolizumab
- Avelumab
- Durvalumab
- Nivolumab
- Pembrolizumab
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator