NCT03427411 · OUTCOME

Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2

M7824 in Subjects With HPV Associated Malignancies · Source last updated 2023-03-28

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: median of 2 years

What was measured

Response based on adequate similarity defined as P-value \> 0.2 with Fisher's exact test of results in cohorts 1 and 2 was compared with a two-sided Fishers exact test, and response was measured by the response evaluation criteria in solid tumors (RECIST)version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).

Analysis population: Only cohorts 1 and 2 was evaluable for this outcome measure.

Groups in this outcome

Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks

Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.

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
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks	29

Reported measurements

Complete Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks	2	Not reported	Not reported	Not reported	Not reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks	7	Not reported	Not reported	Not reported	Not reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks	10	Not reported	Not reported	Not reported	Not reported

Stable Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks	9	Not reported	Not reported	Not reported	Not reported

Not Evaluable

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks	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.

group Ids
OG000
non Inferiority Comment
Non-inferiority was defined as response rates which were sufficiently similar (p\>0.20 by Fisher's exact test).
non Inferiority Type
NON_INFERIORITY
p Value
0.6143
p Value Comment
The p value was calculated and was 0.6143 which is \> 0.2 (pre-defined threshold).
statistical Method
Fisher Exact

Complete source fields

analyses

group Ids
OG000
non Inferiority Comment
Non-inferiority was defined as response rates which were sufficiently similar (p\>0.20 by Fisher's exact test).
non Inferiority Type
NON_INFERIORITY
p Value
0.6143
p Value Comment
The p value was calculated and was 0.6143 which is \> 0.2 (pre-defined threshold).
statistical Method
Fisher Exact

classes

categories
measurements
group Id
OG000
value
2
title
Complete Response
categories
measurements
group Id
OG000
value
7
title
Partial Response
categories
measurements
group Id
OG000
value
10
title
Progressive Disease
categories
measurements
group Id
OG000
value
9
title
Stable Disease
categories
measurements
group Id
OG000
value
1
title
Not Evaluable

denoms

counts
group Id
OG000
value
29
units
Participants

description

groups

description
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
id
OG000
title
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks

param Type

COUNT_OF_PARTICIPANTS

population Description

Only cohorts 1 and 2 was evaluable for this outcome measure.

reporting Status

POSTED

time Frame

median of 2 years

title

Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice