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NCT00623831 · OUTCOME

Number of Participants With Best Overall Tumor Response

A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen · Source last updated 2022-10-25

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 3 months

What was measured

Tumor responses evaluated using computed tomography and categorized according to RECIST version 1.0 at pre-treatment and 4 weeks after the last dose of study treatment. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.

Analysis population: The Tumor Response Analysis Set comprises all subjects who had an end-of-study tumor assessment performed.

Groups in this outcome

Cohort 1 (Tumor Response Analysis Set)

Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.

Cohort 2 (Tumor Response Analysis Set)

Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU \[dose level 6\]) that was determined to be the pyrogenic dose level in Cohort 1.

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

Analysis denominator · Participants

GroupSource count
Cohort 1 (Tumor Response Analysis Set)12
Cohort 2 (Tumor Response Analysis Set)3

Reported measurements

No evidence of disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Tumor Response Analysis Set)2Not reportedNot reportedNot reportedNot reported
Cohort 2 (Tumor Response Analysis Set)1Not reportedNot reportedNot reportedNot reported
Partial response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Tumor Response Analysis Set)1Not reportedNot reportedNot reportedNot reported
Cohort 2 (Tumor Response Analysis Set)0Not reportedNot reportedNot reportedNot reported
Stable disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Tumor Response Analysis Set)0Not reportedNot reportedNot reportedNot reported
Cohort 2 (Tumor Response Analysis Set)1Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Tumor Response Analysis Set)9Not reportedNot reportedNot reportedNot reported
Cohort 2 (Tumor Response Analysis Set)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    No evidence of disease
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Stable disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        1
    title
    Progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Tumor responses evaluated using computed tomography and categorized according to RECIST version 1.0 at pre-treatment and 4 weeks after the last dose of study treatment. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
groups
  1. description
    Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
    id
    OG000
    title
    Cohort 1 (Tumor Response Analysis Set)
  2. description
    Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU \[dose level 6\]) that was determined to be the pyrogenic dose level in Cohort 1.
    id
    OG001
    title
    Cohort 2 (Tumor Response Analysis Set)
param Type
NUMBER
population Description
The Tumor Response Analysis Set comprises all subjects who had an end-of-study tumor assessment performed.
reporting Status
POSTED
time Frame
Up to 3 months
title
Number of Participants With Best Overall Tumor Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice