Clinical Trial Goal
To find out:
- The highest dose of prembrolizumab that is safe to give with decitabine
- If the combination of decitabine and pembrolizumab, with or without venetoclax, is safe and works well to treat AML or MDS
You may be able to join this trial if you:
- Are 18 years old or older
- Have AML or MDS
- Have not been treated with pembrolizumab or another drug that targets PD-1 on certain cells
- Have not been treated with decitabine and venetoclax with no response
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Decitabine is a drug that blocks the growth of cancer cells.
Pembrolizumab is a checkpoint inhibitor that targets PD-1 on certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be 1 of 2 groups:
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be 1 of 2 groups:
- Group 1 – Decitabine and pembrolizumab
- Group 2 – Decitabine and pembrolizumab plus venetoclax
You’ll get treatment in cycles that last 6 weeks. In each cycle, you'll get:
Decitabine – Given as intravenous (IV) infusions 1 time each day for the first 5-10 days of each cycle. Each infusion takes 1 hour
Decitabine – Given as intravenous (IV) infusions 1 time each day for the first 5-10 days of each cycle. Each infusion takes 1 hour
Pembrolizumab - Given as IV infusions 1 time every 3 weeks. Each infusion takes 30 minutes.
Venetoclax - Group 2 only - A pill that you take by mouth 1 time each day for the first 2 weeks of each cycle
Venetoclax - Group 2 only - A pill that you take by mouth 1 time each day for the first 2 weeks of each cycle
You may continue treatment for up to 1 year. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years.
The Food and Drug Administration (FDA) has approved decitabine and venetoclax to treat MDS. Pembrolizumab is approved to treat other cancers. Using these drugs together to treat AML or MDS is new and unproven.
Locations
City of Hope Medical CenterRECRUITING
Duarte, California
Vaibhav Agrawal, 626-256-4673, gmarcucci@coh.org
Sponsors
collaborator: National Cancer Institute (NCI), lead: City of Hope Medical Center
