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NCT03502746 · OUTCOME

Response Rate

Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma · Source last updated 2024-05-14

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to a maximum of 23 months

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Response rate will be defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.

Analysis population: Out of 34 patients, one patient was not evaluable for response after he withdrew from study because of generalized weakness one day after first infusion of ramucirumab and nivolumab.

Groups in this outcome

Nivolumab + Ramucirumab

Nivolumab 240mg IV + Ramucirumab 8mg/kg IV Nivolumab: Nivolumab 240mg, IV over 30 minutes. Ramucirumab: 8mg/kg, IV over 60 minutes.

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

Analysis denominator · Participants

GroupSource count
Nivolumab + Ramucirumab33

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab22.6Not reported9.641.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.6
        upper Limit
        41.1
        value
        22.6
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Response rate will be defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 240mg IV + Ramucirumab 8mg/kg IV Nivolumab: Nivolumab 240mg, IV over 30 minutes. Ramucirumab: 8mg/kg, IV over 60 minutes.
    id
    OG000
    title
    Nivolumab + Ramucirumab
param Type
NUMBER
population Description
Out of 34 patients, one patient was not evaluable for response after he withdrew from study because of generalized weakness one day after first infusion of ramucirumab and nivolumab.
reporting Status
POSTED
time Frame
Up to a maximum of 23 months
title
Response Rate
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice