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NCT03854032 · OUTCOME

Objective Pathologic Response at Time of Surgery

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 time of surgery

What was measured

Pathologic specimens were independently graded by two pathologists as outlined in our previous publication (2). The entire mass or surgical specimen (in the event of a partial/ complete response) was sectioned to calculate the pTR. Criteria for response included evidence of macrophage reaction, multinucleated giant cells and granulomas, fibrosis adjacent to residual tumor nests. In complete responders where no more viable tumor was identified, alteration of the normal tissue architecture by fibrosis and macrophage reaction was used to identify areas of previously viable malignancy. Tumors with pTR of ≥20% were defined as responders (R), while those with pTR \<20% were defined as minimal or non-responders (NR) at the primary site and Lymph Nodes (LNs).

Analysis population: This outcome measure was not analyzed for Arm C because patients from the other study did not receive a second dose if they met pathologic criteria after the first. As such, pathologic response could not be uniformly assessed or carried over for 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

Source class 1

Responders

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: BMS986205 + Nivolumab16Not reportedNot reportedNot reportedNot reported
Arm B: Group I - Nivolumab Only6Not reportedNot reportedNot reportedNot reported

Non-Responders

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: BMS986205 + Nivolumab11Not reportedNot reportedNot reportedNot reported
Arm B: Group I - Nivolumab Only5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        6
      title
      Responders
    2. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        5
      title
      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
Pathologic specimens were independently graded by two pathologists as outlined in our previous publication (2). The entire mass or surgical specimen (in the event of a partial/ complete response) was sectioned to calculate the pTR. Criteria for response included evidence of macrophage reaction, multinucleated giant cells and granulomas, fibrosis adjacent to residual tumor nests. In complete responders where no more viable tumor was identified, alteration of the normal tissue architecture by fibrosis and macrophage reaction was used to identify areas of previously viable malignancy. Tumors with pTR of ≥20% were defined as responders (R), while those with pTR \<20% were defined as minimal or non-responders (NR) at the primary site and Lymph Nodes (LNs).
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
This outcome measure was not analyzed for Arm C because patients from the other study did not receive a second dose if they met pathologic criteria after the first. As such, pathologic response could not be uniformly assessed or carried over for this arm.
reporting Status
POSTED
time Frame
At time of surgery
title
Objective Pathologic Response at Time of Surgery
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice