NCT03710876 · OUTCOME

Best Response: Objective Response Rate (ORR)

Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma · Source last updated 2026-04-21

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: 4 years and 8 months

What was measured

Best overall response (BOR) was defined as the best response designation, in the order of Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE), for each patient that was recorded between the date of randomization and the date of documented disease progression per mRECIST or mRECIST version 1.1, or the date of subsequent anticancer therapy or cancer-related surgery (i.e., surgical resection of tumour), whichever occurred first. ORR was defined as the proportion of patients with a BOR of CR or PR.

Analysis population: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).

Groups in this outcome

Treatment Group

rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination

Control Group

Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination

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

Analysis denominator · Participants

Group	Source count
Treatment Group	27
Control Group	22

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	2	Not reported	Not reported	Not reported	Not reported
Control Group	1	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
-17.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
24.3
estimate Comment
Risk difference is proportion achieving objective response in r+C+G group minus the proportion achieving objective response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
1.0000
p Value Comment
2-sided
param Type
Risk Difference (RD)
param Value
2.9
statistical Method
Fisher Exact

Complete source fields

analyses

ci Lower Limit
-17.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
24.3
estimate Comment
Risk difference is proportion achieving objective response in r+C+G group minus the proportion achieving objective response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
1.0000
p Value Comment
2-sided
param Type
Risk Difference (RD)
param Value
2.9
statistical Method
Fisher Exact

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1

denoms

counts
group Id
OG000
value
27
group Id
OG001
value
22
units
Participants

description

groups

description
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
id
OG000
title
Treatment Group
description
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
id
OG001
title
Control Group

param Type

COUNT_OF_PARTICIPANTS

population Description

The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).

reporting Status

POSTED

time Frame

4 years and 8 months

title

Best Response: Objective Response Rate (ORR)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice