Participant flow

An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself · Source last updated 2021-10-05

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

groups

1. description

   Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.

   id

   FG000

   title

   Cohort A

2. description

   Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.

   id

   FG001

   title

   Cohort B

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         10

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Other reasons

   4. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         2

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Not reported

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         101

      2. group Id

         FG001

         num Subjects

         18

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         59

      2. group Id

         FG001

         num Subjects

         5

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         13

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

119 participants treated

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

Preserved source evidence · Not medical advice