Trial · NCT02252042

Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)

NCT02252042, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2018-08-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040). Trials, record NCT02252042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02252042

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)
NCT number: NCT02252042
Status: Completed
Phases: Phase 3
Enrollment: 495 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Head and Neck Squamous Cell Cancer
Interventions: Pembrolizumab, Methotrexate, Docetaxel, Cetuximab
First posted: 2014-09-29
Last updated: 2023-07-17
Other registries' IDs: eudract:2014-001749-26
Results first posted: 2018-08-13

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Initial Overall Survival (OS) for All Participants	Up to approximately 2 years	OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all participants is presented. These initial OS results are based on a data cutoff date of 15-May-2017 with a database lock date of 04-Jun-2017. At the time of the database lock of 04-Jun-2017, there was incomplete collection of survival data for 12 participants.
Primary	Updated Final OS for All Participants	Up to approximately 2 years	OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The updated OS for all participants is presented. These OS results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Secondary	OS for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Expression Defined by ≥1% Combined Positive Score (CPS)(PD-L1 ≥1% CPS)	Up to approximately 2 years	OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants with PD-L1 expression ≥1% CPS was presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Secondary	Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for All Participants	Up to approximately 2 years	PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The PFS per RECIST 1.1 for all participants is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Secondary	PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS	Up to approximately 2 years	PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The PFS per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Secondary	Objective Response Rate (ORR) Per RECIST 1.1 in All Participants	Up to approximately 2 years	ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation. The ORR per RECIST 1.1 for all participants is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Secondary	ORR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS	Up to approximately 2 years	ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation. The ORR per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Secondary	Duration of Response (DOR) Per RECIST 1.1 in All Participants	Up to approximately 2 years	For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a confirmed CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. DOR assessments were based on blinded central imaging vendor review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Secondary	DOR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS	Up to approximately 2 years	For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a confirmed CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. DOR assessments were based on blinded central imaging vendor review with confirmation. The DOR per RECIST 1.1 for all participants with PD-L1 ≥1% CPS who experienced a confirmed CR or PR is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Secondary	Time to Progression (TTP) Per RECIST 1.1 in All Participants	Up to approximately 2 years	TTP was defined as the time from randomization to the first documented disease progression based on assessments by the blinded central imaging vendor review per RECIST 1.1. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The TTP per RECIST 1.1 for all participants is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Initial Overall Survival (OS) for All Participants	Up to approximately 2 years	The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.	Months	MEDIAN
PRIMARY	Updated Final OS for All Participants	Up to approximately 2 years	The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.	Months	MEDIAN
SECONDARY	OS for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Expression Defined by ≥1% Combined Positive Score (CPS)(PD-L1 ≥1% CPS)	Up to approximately 2 years	The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.	Months	MEDIAN
SECONDARY	Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for All Participants	Up to approximately 2 years	The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.	Months	MEDIAN
SECONDARY	PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS	Up to approximately 2 years	The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.	Months	MEDIAN
SECONDARY	Objective Response Rate (ORR) Per RECIST 1.1 in All Participants	Up to approximately 2 years	The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.	Percentage of Participants	NUMBER
SECONDARY	ORR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS	Up to approximately 2 years	The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.	Percentage of Participants	NUMBER
SECONDARY	Duration of Response (DOR) Per RECIST 1.1 in All Participants	Up to approximately 2 years	The efficacy population consisted of all randomized participants who demonstrated a confirmed CR or PR per RECIST 1.1. Participants are included in the treatment group to which they were randomized.	Months	MEDIAN
SECONDARY	DOR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS	Up to approximately 2 years	The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS who demonstrated a confirmed CR or PR per RECIST 1.1. Participants are included in the treatment group to which they were randomized.	Months	MEDIAN
SECONDARY	Time to Progression (TTP) Per RECIST 1.1 in All Participants	Up to approximately 2 years	The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.	Months	MEDIAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Initial Overall Survival (OS) for All Participants	Pembrolizumab	8.4	95% Confidence Interval 6.5 to 9.4	Months
Initial Overall Survival (OS) for All Participants	Standard Treatment	7.1	95% Confidence Interval 5.9 to 8.1	Months
Updated Final OS for All Participants	Pembrolizumab	8.4	95% Confidence Interval 6.4 to 9.4	Months
Updated Final OS for All Participants	Standard Treatment	6.9	95% Confidence Interval 5.9 to 8.0	Months
OS for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Expression Defined by ≥1% Combined Positive Score (CPS)(PD-L1 ≥1% CPS)	Pembrolizumab	8.7	95% Confidence Interval 6.9 to 11.4	Months
OS for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Expression Defined by ≥1% Combined Positive Score (CPS)(PD-L1 ≥1% CPS)	Standard Treatment	7.1	95% Confidence Interval 5.7 to 8.3	Months
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for All Participants	Pembrolizumab	2.1	95% Confidence Interval 2.1 to 2.3	Months
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for All Participants	Standard Treatment	2.3	95% Confidence Interval 2.1 to 2.8	Months
PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS	Pembrolizumab	2.2	95% Confidence Interval 2.1 to 3.0	Months
PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS	Standard Treatment	2.3	95% Confidence Interval 2.1 to 3.0	Months

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pembrolizumab	247
Overall Study	STARTED	Standard Treatment	248
Overall Study	Received First Course of Pembrolizumab	Pembrolizumab	246
Overall Study	Received First Course of Pembrolizumab	Standard Treatment	234
Overall Study	Received Second Course of Pembrolizumab	Pembrolizumab	2
Overall Study	Received Second Course of Pembrolizumab	Standard Treatment	0
Overall Study	COMPLETED	Pembrolizumab	0
Overall Study	COMPLETED	Standard Treatment	0
Overall Study	NOT COMPLETED	Pembrolizumab	247
Overall Study	NOT COMPLETED	Standard Treatment	248

Source ClinicalTrials.gov

Adverse events576

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Pembrolizumab First Course	61	246	77
other	Anaemia	Blood and lymphatic system disorders	Standard Treatment First Course	53	234	72
other	Anaemia	Blood and lymphatic system disorders	Pembrolizumab Second Course	0	2	0
other	Hypothyroidism	Endocrine disorders	Pembrolizumab First Course	41	246	45
other	Hypothyroidism	Endocrine disorders	Standard Treatment First Course	10	234	10
other	Hypothyroidism	Endocrine disorders	Pembrolizumab Second Course	0	2	0
other	Abdominal pain	Gastrointestinal disorders	Pembrolizumab First Course	9	246	12
other	Abdominal pain	Gastrointestinal disorders	Standard Treatment First Course	12	234	12
other	Abdominal pain	Gastrointestinal disorders	Pembrolizumab Second Course	0	2	0
other	Constipation	Gastrointestinal disorders	Pembrolizumab First Course	43	246	49

1 to 10 of 576Source ClinicalTrials.gov

See all 576 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pembrolizumab First Course	228	247
Total, all-cause mortality	Standard Treatment First Course	243	248
Total, all-cause mortality	Pembrolizumab Second Course	2	2
Total, other adverse events	Pembrolizumab First Course	215	246
Total, other adverse events	Standard Treatment First Course	211	234
Total, other adverse events	Pembrolizumab Second Course	0	2
Total, serious adverse events	Pembrolizumab First Course	110	246
Total, serious adverse events	Standard Treatment First Course	92	234
Total, serious adverse events	Pembrolizumab Second Course	0	2

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25979390	DERIVED	PubMed
30509740	DERIVED	PubMed
30944020	DERIVED	PubMed
33239737	DERIVED	PubMed
33371020	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pembrolizumab vs Standard Treatment: Number of Participants Who Experienced At Least One Adverse Event (AE) in All Participants	Trial comparisons
Pembrolizumab vs Standard Treatment: Number of Participants Who Experienced At Least One AE in Participants With PD-L1 ≥1% CPS	Trial comparisons
Pembrolizumab vs Standard Treatment: Number of Participants Who Discontinued Study Treatment Due to an AE in Participants With PD-L1 ≥1% CPS	Trial comparisons
Pembrolizumab vs Standard Treatment: Number of Participants Who Discontinued Study Treatment Due to an AE in All Participants	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02252042

GET https://conductscience.org/api/trials/v1/NCT02252042/results?page=2

API reference For AI assistants