Participant flow

Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-05-03

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

groups

1. description

   Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

   id

   FG000

   title

   Treatment A - Platinum Refractory Subgroup

2. description

   Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W

   id

   FG001

   title

   Treatment B - Platinum Refractory Subgroup

3. description

   Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

   id

   FG002

   title

   Treatment A - Platinum Eligible Subgroup

4. description

   Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W

   id

   FG003

   title

   Treatment B - Platinum Eligible Subgroup

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      AE unrelated to Study Drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         159

      2. group Id

         FG001

         num Subjects

         82

      3. group Id

         FG002

         num Subjects

         123

      4. group Id

         FG003

         num Subjects

         61

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         158

      2. group Id

         FG001

         num Subjects

         82

      3. group Id

         FG002

         num Subjects

         122

      4. group Id

         FG003

         num Subjects

         61

      comment

      Continuing to Treatment Period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Randomization

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      type

      Poor/Non Compliance

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         1

      type

      Maximum Clinical Benefit

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      type

      Participant withdrew consent

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         2

      type

      Participant request to discontinue

   6. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         2

      type

      Adverse Event unrelated to to study Drug

   7. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         14

      4. group Id

         FG003

         num Subjects

         4

      type

      Study Drug Toxicity

   8. reasons

      1. group Id

         FG000

         num Subjects

         113

      2. group Id

         FG001

         num Subjects

         64

      3. group Id

         FG002

         num Subjects

         82

      4. group Id

         FG003

         num Subjects

         43

      type

      Disease Progression

   9. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         6

      type

      Other reasons

   10. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          0

       3. group Id

          FG002

          num Subjects

          1

       4. group Id

          FG003

          num Subjects

          0

       type

       Participant no longer meets study criteria

   11. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          0

       3. group Id

          FG002

          num Subjects

          3

       4. group Id

          FG003

          num Subjects

          1

       type

       Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         158

      2. group Id

         FG001

         num Subjects

         82

      3. group Id

         FG002

         num Subjects

         122

      4. group Id

         FG003

         num Subjects

         61

      type

      STARTED

   2. 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

      comment

      Completed = Continuing in the Treatment Period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         158

      2. group Id

         FG001

         num Subjects

         82

      3. group Id

         FG002

         num Subjects

         122

      4. group Id

         FG003

         num Subjects

         61

      type

      NOT COMPLETED

   title

   Treatment Period

pre Assignment Details

425 randomized and 423 participants treated.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice