Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03854032 · OUTCOME

Objective Response

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At 5 weeks

What was measured

Radiographic response was assessed at the primary site and involved lymph nodes. Participants with ≥10% volumetric reduction at either site and no progression received a second treatment cycle before surgery, while those with stable disease or progression proceeded to surgery at the 5-week evaluation. The study hypothesized that adding an IDO inhibitor to PD-1 blockade would improve radiographic response. The primary endpoint was the proportion of participants eligible for a second cycle. The 10% cutoff was based on prior publications showing that volumetric analysis is more sensitive than single-axis RECIST v1.1 and allows minor immune-related increases (0-9%) while defining \>10% growth as progression.

Analysis population: Only 27 participants were analyzed for Arm A, 4 patients withdrew.

Groups in this outcome

Arm A: BMS986205 + Nivolumab

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: Given IV IDO1 Inhibitor BMS-986205: Given PO Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies

Arm B: Group I - Nivolumab Only

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: Given IV Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies

Arm C: Group II - Nivolumab Only

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A: BMS986205 + Nivolumab27
Arm B: Group I - Nivolumab Only11
Arm C: Group II - Nivolumab Only19

Reported measurements

Radiographic Responders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: BMS986205 + Nivolumab13Not reportedNot reportedNot reportedNot reported
Arm B: Group I - Nivolumab Only4Not reportedNot reportedNot reportedNot reported
Arm C: Group II - Nivolumab Only10Not reportedNot reportedNot reportedNot reported
Radiographic Non-Responders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: BMS986205 + Nivolumab14Not reportedNot reportedNot reportedNot reported
Arm B: Group I - Nivolumab Only7Not reportedNot reportedNot reportedNot reported
Arm C: Group II - Nivolumab Only9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        10
    title
    Radiographic Responders
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        9
    title
    Radiographic Non-Responders
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      19
    units
    Participants
description
Radiographic response was assessed at the primary site and involved lymph nodes. Participants with ≥10% volumetric reduction at either site and no progression received a second treatment cycle before surgery, while those with stable disease or progression proceeded to surgery at the 5-week evaluation. The study hypothesized that adding an IDO inhibitor to PD-1 blockade would improve radiographic response. The primary endpoint was the proportion of participants eligible for a second cycle. The 10% cutoff was based on prior publications showing that volumetric analysis is more sensitive than single-axis RECIST v1.1 and allows minor immune-related increases (0-9%) while defining \>10% growth as progression.
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: Given IV IDO1 Inhibitor BMS-986205: Given PO Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies
    id
    OG000
    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: Given IV Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies
    id
    OG001
    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.
    id
    OG002
    title
    Arm C: Group II - Nivolumab Only
param Type
COUNT_OF_PARTICIPANTS
population Description
Only 27 participants were analyzed for Arm A, 4 patients withdrew.
reporting Status
POSTED
time Frame
At 5 weeks
title
Objective Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice