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NCT03854032 · OUTCOME

Ratio of Tryptophan to Kynurenine

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
MEDIAN
Unit
Ratio of Tryptophan to Kynurenine
Interval / dispersion
Full Range
Time frame
Up to 12 months

What was measured

Tryptophan and kynurenine concentrations were measured in plasma samples using validated assays. The outcome is expressed as the ratio of tryptophan to kynurenine, a marker of IDO1 activity. Results are reported as median values with full range (minimum to maximum) across participants

Analysis population: This outcome measure was not analyzed for Arm C because, per protocol, the contemporaneous cohort was only used to support specific objectives such as the primary endpoint. Data collection and procedures for other measures were not conducted in this arm.

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 Only0

Reported measurements

Pre-Kynurenine Responders

Analysis denominator · Participants

GroupSource count
Arm A: BMS986205 + Nivolumab15
Arm B: Group I - Nivolumab Only6
Arm C: Group II - Nivolumab Only0
Values in Ratio of Tryptophan to Kynurenine · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm A: BMS986205 + Nivolumab0.5Not reported-11.8Not reported
Arm B: Group I - Nivolumab Only-0.1Not reported-1.40.65Not reported
Pre-Kynurenine Non-Responders

Analysis denominator · Participants

GroupSource count
Arm A: BMS986205 + Nivolumab12
Arm B: Group I - Nivolumab Only5
Arm C: Group II - Nivolumab Only0
Values in Ratio of Tryptophan to Kynurenine · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm A: BMS986205 + Nivolumab-0.2Not reported-1.31Not reported
Arm B: Group I - Nivolumab Only0Not reported-1.20.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1
        upper Limit
        1.8
        value
        0.5
      2. group Id
        OG001
        lower Limit
        -1.4
        upper Limit
        0.65
        value
        -0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Pre-Kynurenine Responders
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.3
        upper Limit
        1
        value
        -0.2
      2. group Id
        OG001
        lower Limit
        -1.2
        upper Limit
        0.8
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Pre-Kynurenine Non-Responders
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Tryptophan and kynurenine concentrations were measured in plasma samples using validated assays. The outcome is expressed as the ratio of tryptophan to kynurenine, a marker of IDO1 activity. Results are reported as median values with full range (minimum to maximum) across participants
dispersion Type
Full Range
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
MEDIAN
population Description
This outcome measure was not analyzed for Arm C because, per protocol, the contemporaneous cohort was only used to support specific objectives such as the primary endpoint. Data collection and procedures for other measures were not conducted in this arm.
reporting Status
POSTED
time Frame
Up to 12 months
title
Ratio of Tryptophan to Kynurenine
type
SECONDARY
unit Of Measure
Ratio of Tryptophan to Kynurenine

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Preserved source evidence · Not medical advice