Participant flow

A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies · Source last updated 2022-09-27

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

groups

1. description

   Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.

   id

   FG000

   title

   Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg

2. description

   Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.

   id

   FG001

   title

   Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg

3. description

   Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.

   id

   FG002

   title

   Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg

4. description

   Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.

   id

   FG003

   title

   Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg

5. description

   Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.

   id

   FG004

   title

   Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg

6. description

   Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.

   id

   FG005

   title

   Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg

7. description

   Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.

   id

   FG006

   title

   Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg

8. description

   Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.

   id

   FG007

   title

   Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg

9. description

   Participants with advanced or metastatic select solid tumors were to have received INCAGN01949 at the assigned dose level Q2W in combination with nivolumab 3 mg/kg Q2W and ipilimumab 1 mg/kg Q6W, all administered as IV infusions beginning on Cycle 1 Day 1.

   id

   FG008

   title

   Phase 1, Dose Escalation: INCAGN01949 + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg

10. description

    Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.

    id

    FG009

    title

    Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg

11. description

    Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.

    id

    FG010

    title

    Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg

12. description

    Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.

    id

    FG011

    title

    Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg

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periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         3

      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

          4

      12. group Id

          FG011

          num Subjects

          3

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      type

      Death

   2. 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

      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

         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 15)

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         1

      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

          2

      12. group Id

          FG011

          num Subjects

          3

      Show more (12 of 15)

      type

      Survival Follow-up No Longer Required per Protocol Amendment

   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

         1

      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

          1

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

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      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         4

      8. group Id

         FG007

         num Subjects

         3

      9. comment

         This treatment group did not open for enrollment.

         group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          6

      11. group Id

          FG010

          num Subjects

          6

      12. group Id

          FG011

          num Subjects

          6

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      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

         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

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      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         4

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          6

      11. group Id

          FG010

          num Subjects

          6

      12. group Id

          FG011

          num Subjects

          6

      Show more (12 of 15)

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

This study was conducted at 13 study centers in the United States in two parts: dose escalation (Part 1) and safety expansion (Part 2).

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice