Participant flow

A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors · Source last updated 2024-12-27

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

groups

1. description

   Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W

   id

   FG000

   title

   TNBC Arm N

2. description

   Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

   id

   FG001

   title

   TNBC Arm N-I Dose Level 1

3. description

   Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

   id

   FG002

   title

   TNBC Arm N-I Dose Level 2

4. description

   Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W

   id

   FG003

   title

   GC Arm N

5. description

   Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

   id

   FG004

   title

   GC Arm N-I Dose Level 1

6. description

   Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W

   id

   FG005

   title

   GC Arm N-I Dose Level 2

7. description

   Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

   id

   FG006

   title

   GC Arm N-I Dose Level 2b

8. description

   Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W

   id

   FG007

   title

   PC Arm N

9. description

   Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

   id

   FG008

   title

   PC Arm N-I Dose Level 1

10. description

    Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

    id

    FG009

    title

    PC Arm N-I Dose Level 2

11. description

    Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off

    id

    FG010

    title

    PC Arm N-I Dose Level 2d

12. description

    Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W

    id

    FG011

    title

    SCLC Arm N - Pre-expansion

Show more (12 of 23)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         48

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         25

      7. group Id

         FG006

         num Subjects

         38

      8. group Id

         FG007

         num Subjects

         16

      9. group Id

         FG008

         num Subjects

         3

      10. group Id

          FG009

          num Subjects

          11

      11. group Id

          FG010

          num Subjects

          22

      12. group Id

          FG011

          num Subjects

          73

      Show more (12 of 23)

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         9

      7. group Id

         FG006

         num Subjects

         7

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          5

      11. group Id

          FG010

          num Subjects

          2

      12. group Id

          FG011

          num Subjects

          3

      Show more (12 of 23)

      type

      Study drug toxicity

   3. 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

         3

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          2

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          12

      Show more (12 of 23)

      type

      AE unrelated to study drug

   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

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         3

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          3

      12. group Id

          FG011

          num Subjects

          2

      Show more (12 of 23)

      type

      Participant request to stop therapy

   5. 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

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          1

      12. group Id

          FG011

          num Subjects

          1

      Show more (12 of 23)

      type

      Participant withdrew consent

   6. 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

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 23)

      type

      Poor/non-compliance

   7. 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

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          1

      12. group Id

          FG011

          num Subjects

          1

      Show more (12 of 23)

      type

      other reason

   8. 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

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          1

      12. group Id

          FG011

          num Subjects

          1

      Show more (12 of 23)

      type

      Maximum clinical benefit

   9. 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

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 23)

      type

      Lost to Follow-up

   10. 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

          0

       5. group Id

          FG004

          num Subjects

          0

       6. group Id

          FG005

          num Subjects

          0

       7. group Id

          FG006

          num Subjects

          0

       8. group Id

          FG007

          num Subjects

          0

       9. group Id

          FG008

          num Subjects

          0

       10. group Id

           FG009

           num Subjects

           0

       11. group Id

           FG010

           num Subjects

           0

       12. group Id

           FG011

           num Subjects

           0

       Show more (12 of 23)

       type

       Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         59

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         49

      7. group Id

         FG006

         num Subjects

         52

      8. group Id

         FG007

         num Subjects

         18

      9. group Id

         FG008

         num Subjects

         3

      10. group Id

          FG009

          num Subjects

          18

      11. group Id

          FG010

          num Subjects

          30

      12. group Id

          FG011

          num Subjects

          98

      Show more (12 of 23)

      comment

      Started = Entering initial treatment or combination treatment after completion of monotherapy(MT)

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          17

      Show more (12 of 23)

      comment

      Participants who will transition after completing MT due to disease progression (DP)

      type

      Transition

   3. achievements

      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

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         6

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         1

      10. group Id

          FG009

          num Subjects

          1

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 23)

      comment

      Participants who were transitioned to another treatment after disease progression (DP).

      type

      Transition- Continued

   4. 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

         3

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         3

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          5

      Show more (12 of 23)

      comment

      Completed = continuing treatment period

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         56

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         43

      7. group Id

         FG006

         num Subjects

         49

      8. group Id

         FG007

         num Subjects

         18

      9. group Id

         FG008

         num Subjects

         3

      10. group Id

          FG009

          num Subjects

          18

      11. group Id

          FG010

          num Subjects

          30

      12. group Id

          FG011

          num Subjects

          93

      Show more (12 of 23)

      type

      NOT COMPLETED

   title

   Treatment Period

2. drop Withdraws

   1. 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

         4

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         5

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          5

      12. group Id

          FG011

          num Subjects

          8

      Show more (12 of 23)

      type

      Participant withdrew consent

   2. 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

         6

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         6

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         1

      10. group Id

          FG009

          num Subjects

          2

      11. group Id

          FG010

          num Subjects

          4

      12. group Id

          FG011

          num Subjects

          12

      Show more (12 of 23)

      type

      Death

   3. 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

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          2

      12. group Id

          FG011

          num Subjects

          1

      Show more (12 of 23)

      type

      other reason

   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

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          1

      Show more (12 of 23)

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         50

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         49

      7. group Id

         FG006

         num Subjects

         52

      8. group Id

         FG007

         num Subjects

         16

      9. group Id

         FG008

         num Subjects

         3

      10. group Id

          FG009

          num Subjects

          18

      11. group Id

          FG010

          num Subjects

          30

      12. group Id

          FG011

          num Subjects

          81

      Show more (12 of 23)

      comment

      started = number of Participants regardless of continuing treatment or not.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         15

      4. group Id

         FG003

         num Subjects

         40

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         41

      7. group Id

         FG006

         num Subjects

         40

      8. group Id

         FG007

         num Subjects

         10

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          16

      11. group Id

          FG010

          num Subjects

          19

      12. group Id

          FG011

          num Subjects

          59

      Show more (12 of 23)

      comment

      completed = continuing to be followed

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         10

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         12

      8. group Id

         FG007

         num Subjects

         6

      9. group Id

         FG008

         num Subjects

         1

      10. group Id

          FG009

          num Subjects

          2

      11. group Id

          FG010

          num Subjects

          11

      12. group Id

          FG011

          num Subjects

          22

      Show more (12 of 23)

      type

      NOT COMPLETED

   title

   Follow-up Period

pre Assignment Details

1131 participants were treated in total for TNBC, GC, PC, SCLC, BC and OC.

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

Preserved source evidence · Not medical advice