Participant flow

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors · Source last updated 2023-11-13

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

groups

1. description

   Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first

   id

   FG000

   title

   Metastatic Monotherapy

2. description

   Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first

   id

   FG001

   title

   Metastatic Combo A

3. description

   Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first

   id

   FG002

   title

   Metastatic Combo B

4. description

   Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first

   id

   FG003

   title

   Metastatic Combo C

5. description

   Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first

   id

   FG004

   title

   Metastatic Combo D

6. description

   Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15

   id

   FG005

   title

   Neoadjuvant

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         73

      2. group Id

         FG001

         num Subjects

         111

      3. group Id

         FG002

         num Subjects

         62

      4. group Id

         FG003

         num Subjects

         7

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         2

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         33

      3. group Id

         FG002

         num Subjects

         31

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         2

      type

      Study drug toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      type

      Adverse event unrelated to study drug

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Participant request to discontinue study treatment

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         2

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Maximum clinical benefit

   8. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         32

      3. group Id

         FG002

         num Subjects

         23

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         1

      type

      Other reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         113

      2. group Id

         FG001

         num Subjects

         195

      3. group Id

         FG002

         num Subjects

         133

      4. group Id

         FG003

         num Subjects

         8

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         123

      comment

      Started = treated

      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

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         116

      comment

      Completed = completed the treatment period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         113

      2. group Id

         FG001

         num Subjects

         195

      3. group Id

         FG002

         num Subjects

         133

      4. group Id

         FG003

         num Subjects

         8

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         7

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

578 participants treated

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

Preserved source evidence · Not medical advice