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NCT03504397 · OUTCOME

Objective Response Rate (ORR)

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. · Source last updated 2026-05-04

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
From the date of randomization until 62 months and 18 days

What was measured

ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as was assessed by IRC per RECIST 1.1. CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.

Analysis population: FAS

Groups in this outcome

mFOLFOX6 + Zolbetuximab

Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.

mFOLFOX6+ Placebo

Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.

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

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab283
mFOLFOX6+ Placebo282

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab48.1Not reported42.1154.05Not reported
mFOLFOX6+ Placebo47.5Not reported41.5653.52Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4536
    statistical Comment
    Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4536
    statistical Comment
    Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.11
        upper Limit
        54.05
        value
        48.1
      2. group Id
        OG001
        lower Limit
        41.56
        upper Limit
        53.52
        value
        47.5
denoms
  1. counts
    1. group Id
      OG000
      value
      283
    2. group Id
      OG001
      value
      282
    units
    Participants
description
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as was assessed by IRC per RECIST 1.1. CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
    id
    OG000
    title
    mFOLFOX6 + Zolbetuximab
  2. description
    Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
    id
    OG001
    title
    mFOLFOX6+ Placebo
param Type
NUMBER
population Description
FAS
reporting Status
POSTED
time Frame
From the date of randomization until 62 months and 18 days
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice