Participant flow

Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck · Source last updated 2026-10-19

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

groups

1. description

   Patients receive IDO1 inhibitor BMS-986205 PO QD. Beginning week 2, patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients showing a treatment response receive IDO1 inhibitor BMS-986205 PO QD for 4 additional weeks and receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 10. Those without a treatment response after 5 weeks undergo surgery within 7 days. Nivolumab is administered as a 480mg intravenous (IV) infusion once every 4 weeks. BMS986205 is administered orally at a dose of 100 mg once daily.

   id

   FG000

   title

   Arm A: BMS986205 + Nivolumab

2. description

   Patients receive nivolumab IV over 30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients showing treatment response after 4 weeks receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 9. Those without a treatment response after 4 weeks undergo surgery within 7 days. Nivolumab is administered as a 480mg intravenous (IV) infusion once every 4 weeks.

   id

   FG001

   title

   Arm B: Group I - Nivolumab Only

3. description

   Data from Contemporaneous Study 10237 (NCT03238365) participants who received Nivolumab alone prior to surgery is used as a historical controls under the current window of treatment (WOT), to bolster the control group. Nivolumab was administered as a 240mg intravenous (IV) infusion every 2 weeks for 2 doses over a 4-week treatment period prior to surgical resection.

   id

   FG002

   title

   Arm C: Group II - Nivolumab Only

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         23

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         19

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice