Participant flow

Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer · Source last updated 2022-10-10

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

groups

1. description

   Subjects received pegylated liposomal doxorubicin (PLD) (40 mg/m\^2 intravenously \[IV\] on Day 1 of every cycle) + durvalumab (3 mg/kg every 2 weeks \[Q2W, equivalent to 450 mg every 4 weeks (Q4W)\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 subcutaneous \[SC\]) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.

   id

   FG000

   title

   Phase 1, Dose Level 0a

2. description

   Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.

   id

   FG001

   title

   Phase 1, Dose Level 0b

3. description

   Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.

   id

   FG002

   title

   Phase 1, Dose Level +1

4. description

   Subjects received the maximum tolerated dose (MTD) determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.

   id

   FG003

   title

   Phase 2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         4

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         22

      type

      Progressive disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         4

      type

      Withdrawal by Subject

   4. reasons

      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

         1

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         40

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         9

      comment

      Completed 12 cycles of study treatment

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         31

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice