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NCT03586999 · OUTCOME

Immune-related Predictors of Response

Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas · Source last updated 2024-10-29

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

Measure
NUMBER
Unit
odds ratio
Interval / dispersion
95% Confidence Interval
Time frame
Within 6 months of treatment

What was measured

We assessed PD-L1 expression using immunohistochemistry on pre-treatment tumor tissue. The outcome of measurement was complete response yes vs. no. Using logistic regression, we assessed if the percentage of PDL1+ cells was predictive of achieving a complete response.

Analysis population: Only 17 participants had tumor tissue available.

Groups in this outcome

Nivo and EPOCH

Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.

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

Analysis denominator · Participants

GroupSource count
Nivo and EPOCH17

Reported measurements

Source class 1
Values in odds ratio · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivo and EPOCH0.985Not reported0.9381.034Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.938
        upper Limit
        1.034
        value
        0.985
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
We assessed PD-L1 expression using immunohistochemistry on pre-treatment tumor tissue. The outcome of measurement was complete response yes vs. no. Using logistic regression, we assessed if the percentage of PDL1+ cells was predictive of achieving a complete response.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
    id
    OG000
    title
    Nivo and EPOCH
param Type
NUMBER
population Description
Only 17 participants had tumor tissue available.
reporting Status
POSTED
time Frame
Within 6 months of treatment
title
Immune-related Predictors of Response
type
SECONDARY
unit Of Measure
odds ratio

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

Preserved source evidence · Not medical advice