PD-1/PD-L1 Inhibitor Therapy Duration for Cancer
Trial Summary
What is the purpose of this trial?
Based on the overwhelming positive response to this survey and the large number of patients being treated with PD-1/PD-L1 therapy in the UPMC system, the investigators are proposing a trial that will randomize patients who have disease stability to stop treatment at 1 year or continue treatment until disease progression. The investigators anticipate that the results of this study will answer questions regarding the optimal duration of treatment. therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. It focuses on patients already being treated with PD-1/PD-L1 inhibitors, so you may continue those treatments.
What data supports the effectiveness of the PD-1/PD-L1 Inhibitor drug for cancer?
What safety data exists for PD-1/PD-L1 inhibitor therapy in humans?
PD-1/PD-L1 inhibitors have been studied for their safety in treating various cancers, including non-small cell lung cancer and melanoma. Common side effects include immune-related adverse events, which can affect different body systems, but there are management strategies to handle these. Overall, these treatments have shown a balance of safety and effectiveness in clinical trials.56789
How is PD-1/PD-L1 Inhibitor therapy different from other cancer treatments?
PD-1/PD-L1 Inhibitor therapy is unique because it involves immune checkpoint inhibitors that help the immune system recognize and attack cancer cells. Unlike traditional treatments, the optimal duration for this therapy is still being studied, with some trials exploring shorter treatment periods to balance effectiveness and reduce side effects.25101112
Research Team
Jason Luke, MD
Principal Investigator
UPMC Hillman Cancer Center
Eligibility Criteria
This trial is for adults with advanced solid tumors (like lung, bladder, kidney cancer, etc.) who are responding to PD-1/PD-L1 inhibitors. They must have stable disease shown in scans within 6 weeks of joining and can't be on another clinical trial. Those with progressing disease or immune-related toxicity that stops treatment aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PD-1/PD-L1 inhibitor treatment for 12 months
Follow-up
Participants are monitored for progression-free survival and overall survival
Extension
Participants may continue or discontinue treatment based on randomization after 12 months
Treatment Details
Interventions
- PD-1/PD-L1 Inhibitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jason J. Luke, MD
Lead Sponsor
Antoinette J Wozniak
Lead Sponsor
Antoinette J Wozniak, MD
Lead Sponsor