Participant flow

Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2025-06-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV

   id

   FG000

   title

   Arm 1 A Lead-In (Azacitidine, Nivolumab)

2. description

   Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV

   id

   FG001

   title

   Arm 1 B (Azacitidine, Nivolumab)

3. description

   Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV

   id

   FG002

   title

   Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)

4. description

   Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV

   id

   FG003

   title

   Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)

5. description

   Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV

   id

   FG004

   title

   Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)

6. description

   Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV

   id

   FG005

   title

   Arm 3 B (Azacitidine, Nivolumab, Venetoclax)

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         85

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         47

      5. group Id

         FG004

         num Subjects

         6

      6. comment

         There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.

         group Id

         FG005

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         85

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         47

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice