NCT04472429 · BASELINE

Baseline characteristics

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). · Source last updated 2026-09-02

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

denoms

counts
group Id
BG000
value
154
group Id
BG001
value
154
group Id
BG002
value
308
units
Participants

groups

description
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
id
BG000
title
Retifanlimab 500 mg Q4W + Chemotherapy
description
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
id
BG001
title
Placebo + Chemotherapy
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.81
value
61.6
group Id
BG001
spread
10.51
value
61.1
group Id
BG002
spread
10.15
value
61.3
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
104
group Id
BG001
value
118
group Id
BG002
value
222
title
Female
measurements
group Id
BG000
value
50
group Id
BG001
value
36
group Id
BG002
value
86
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
132
group Id
BG001
value
137
group Id
BG002
value
269
title
White/Caucasian
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Black/African-American
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
18
title
Asian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Multiple Races
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Not Reported
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Missing
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Mexican
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Mixed: White/Indian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
White or Other
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
White British
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Captured as "Other" in Database
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
8
group Id
BG002
value
21
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
129
group Id
BG001
value
132
group Id
BG002
value
261
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Not Reported
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
11
group Id
BG002
value
21
title
Unknown
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
154
group Id
BG001
value
154
group Id
BG002
value
308
units
Participants

groups

description
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
id
BG000
title
Retifanlimab 500 mg Q4W + Chemotherapy
description
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
id
BG001
title
Placebo + Chemotherapy
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.81
value
61.6
group Id
BG001
spread
10.51
value
61.1
group Id
BG002
spread
10.15
value
61.3
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
104
group Id
BG001
value
118
group Id
BG002
value
222
title
Female
measurements
group Id
BG000
value
50
group Id
BG001
value
36
group Id
BG002
value
86
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
132
group Id
BG001
value
137
group Id
BG002
value
269
title
White/Caucasian
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Black/African-American
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
18
title
Asian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Multiple Races
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Not Reported
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Missing
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Mexican
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Mixed: White/Indian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
White or Other
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
White British
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Captured as "Other" in Database
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
8
group Id
BG002
value
21
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
129
group Id
BG001
value
132
group Id
BG002
value
261
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Not Reported
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
11
group Id
BG002
value
21
title
Unknown
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants

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Preserved source evidence · Not medical advice