NCT01721746 · OUTCOME

Objective Response Rate (ORR) by Baseline PD-L1 Expression

A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037) · Source last updated 2022-04-19

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 date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)

What was measured

Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.

Analysis population: All PD-L1 Evaluable Participants for ORR

Groups in this outcome

Nivolumab

Nivolumab 3 mg/kg IV over 60 minutes Q2W

Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W

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
Nivolumab	267
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	131

Reported measurements

<5% PD-L1 expression

Analysis denominator · Participants

Group	Source count
Nivolumab	137
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	58

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	15.3	Not reported	9.7	22.5	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	13.8	Not reported	6.1	25.4	Not reported

>=5% PD-L1 expression

Analysis denominator · Participants

Group	Source count
Nivolumab	111
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	41

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	43.2	Not reported	33.9	53.0	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	12.2	Not reported	4.1	26.2	Not reported

Source statistical analyses

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

ci Lower Limit
0.44
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.16
group Description
For \<5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Odds Ratio (OR)
param Value
1.13
ci Lower Limit
1.92
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.08
group Description
For \>=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Odds Ratio (OR)
param Value
5.49

Complete source fields

analyses

ci Lower Limit
0.44
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.16
group Description
For \<5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Odds Ratio (OR)
param Value
1.13
ci Lower Limit
1.92
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.08
group Description
For \>=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Odds Ratio (OR)
param Value
5.49

classes

categories
measurements
group Id
OG000
lower Limit
9.7
upper Limit
22.5
value
15.3
group Id
OG001
lower Limit
6.1
upper Limit
25.4
value
13.8
denoms
counts
group Id
OG000
value
137
group Id
OG001
value
58
units
Participants
title
<5% PD-L1 expression
categories
measurements
group Id
OG000
lower Limit
33.9
upper Limit
53.0
value
43.2
group Id
OG001
lower Limit
4.1
upper Limit
26.2
value
12.2
denoms
counts
group Id
OG000
value
111
group Id
OG001
value
41
units
Participants
title
>=5% PD-L1 expression

denoms

counts
group Id
OG000
value
267
group Id
OG001
value
131
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Nivolumab 3 mg/kg IV over 60 minutes Q2W
id
OG000
title
Nivolumab
description
Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W
id
OG001
title
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

param Type

NUMBER

population Description

All PD-L1 Evaluable Participants for ORR

reporting Status

POSTED

time Frame

From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)

title

Objective Response Rate (ORR) by Baseline PD-L1 Expression

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice