Trial · NCT02358031
A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)
NCT02358031, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2020-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048). Trials, record NCT02358031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02358031
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)
- NCT number
- NCT02358031
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 882 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer
- Interventions
- Pembrolizumab, Cisplatin, Carboplatin, 5-FU, Cetuximab
- First posted
- 2015-02-06
- Last updated
- 2025-07-18
- Other registries' IDs
- eudract:2014-003698-41
- Results first posted
- 2020-02-17
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pembro Combo vs Control: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Participants | Up to approximately 47 months | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm. Per protocol, PFS was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record. |
| Primary | Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 | Up to approximately 47 months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as Combined Positive Score ≥1 (hereafter referred to as CPS ≥1). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record. |
| Primary | Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20 | Up to approximately 47 months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as Combined Positive Score ≥20 (hereafter referred to as CPS ≥20). Per protocol, PFS was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record. |
| Primary | Pembro Combo vs Control: Overall Survival (OS) in All Participants | Up to approximately 47 months | 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. Per protocol, OS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm. Per protocol, OS was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record. |
| Primary | Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥1 | Up to approximately 47 months | 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. Per protocol, OS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record. |
| Primary | Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥20 | Up to approximately 47 months | 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. Per protocol, OS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, OS was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record. |
| Primary | Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in All Participants | Up to approximately 47 months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record. |
| Primary | Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 | Up to approximately 47 months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record. |
| Primary | Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20 | Up to approximately 47 months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, PFS was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record. |
| Primary | Pembro Mono vs Control: OS in All Participants | Up to approximately 47 months | 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. Per protocol, OS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm. Per protocol, OS was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pembro Combo vs Control: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Participants | Up to approximately 47 months | All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 | Up to approximately 47 months | Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20 | Up to approximately 47 months | Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Combo vs Control: Overall Survival (OS) in All Participants | Up to approximately 47 months | All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥1 | Up to approximately 47 months | Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥20 | Up to approximately 47 months | Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in All Participants | Up to approximately 47 months | All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 | Up to approximately 47 months | All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20 | Up to approximately 47 months | All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Mono vs Control: OS in All Participants | Up to approximately 47 months | All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis. | Months | MEDIAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pembro Combo vs Control: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Participants | Pembrolizumab + Chemotherapy (Pembro Combo) | 4.9 | 95% Confidence Interval 4.7 to 6.1 | Months | |
| Pembro Combo vs Control: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Participants | Cetuximab + Chemotherapy (Control) | 5.2 | 95% Confidence Interval 4.9 to 6.1 | Months | |
| Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 | Pembrolizumab + Chemotherapy (Pembro Combo) | 5.1 | 95% Confidence Interval 4.7 to 6.2 | Months | |
| Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 | Cetuximab + Chemotherapy (Control) | 5.0 | 95% Confidence Interval 4.8 to 6.0 | Months | |
| Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20 | Pembrolizumab + Chemotherapy (Pembro Combo) | 5.8 | 95% Confidence Interval 4.7 to 7.6 | Months | |
| Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20 | Cetuximab + Chemotherapy (Control) | 5.3 | 95% Confidence Interval 4.9 to 6.3 | Months | |
| Pembro Combo vs Control: Overall Survival (OS) in All Participants | Pembrolizumab + Chemotherapy (Pembro Combo) | 13.0 | 95% Confidence Interval 10.9 to 14.7 | Months | |
| Pembro Combo vs Control: Overall Survival (OS) in All Participants | Cetuximab + Chemotherapy (Control) | 10.7 | 95% Confidence Interval 9.3 to 11.7 | Months | |
| Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥1 | Pembrolizumab + Chemotherapy (Pembro Combo) | 13.6 | 95% Confidence Interval 10.7 to 15.5 | Months | |
| Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥1 | Cetuximab + Chemotherapy (Control) | 10.4 | 95% Confidence Interval 9.1 to 11.7 | Months |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab Monotherapy (Pembro Mono) | 301 | |
| Overall Study | STARTED | Pembrolizumab + Chemotherapy (Pembro Combo) | 281 | |
| Overall Study | STARTED | Cetuximab + Chemotherapy (Control) | 300 | |
| Overall Study | Treated | Pembrolizumab Monotherapy (Pembro Mono) | 300 | |
| Overall Study | Treated | Pembrolizumab + Chemotherapy (Pembro Combo) | 276 | |
| Overall Study | Treated | Cetuximab + Chemotherapy (Control) | 287 | |
| Overall Study | Pembro Mono v Control Efficacy Analyses | Pembrolizumab Monotherapy (Pembro Mono) | 301 | |
| Overall Study | Pembro Mono v Control Efficacy Analyses | Pembrolizumab + Chemotherapy (Pembro Combo) | 0 | |
| Overall Study | Pembro Mono v Control Efficacy Analyses | Cetuximab + Chemotherapy (Control) | 300 | |
| Overall Study | Pembro Combo v Control Efficacy Analyses | Pembrolizumab Monotherapy (Pembro Mono) | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,920
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 Monotherapy (First Course) | 61 | 300 | 82 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + Chemotherapy (First Course) | 153 | 276 | 210 |
| other | Anaemia | Blood and lymphatic system disorders | Cetuximab + Chemotherapy (Control) | 128 | 287 | 251 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab Monotherapy (Second Course) | 2 | 8 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + Chemotherapy (Second Course) | 1 | 6 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab Monotherapy (First Course) | 4 | 300 | 5 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + Chemotherapy (First Course) | 37 | 276 | 57 |
| other | Leukopenia | Blood and lymphatic system disorders | Cetuximab + Chemotherapy (Control) | 41 | 287 | 87 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab Monotherapy (Second Course) | 0 | 8 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + Chemotherapy (Second Course) | 0 | 6 | 0 |
1 to 10 of 1,920Source ClinicalTrials.gov
See all 1,920 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab Monotherapy (First Course) | 260 | 301 |
| Total, all-cause mortality | Pembrolizumab + Chemotherapy (First Course) | 242 | 281 |
| Total, all-cause mortality | Cetuximab + Chemotherapy (Control) | 282 | 300 |
| Total, all-cause mortality | Pembrolizumab Monotherapy (Second Course) | 5 | 8 |
| Total, all-cause mortality | Pembrolizumab + Chemotherapy (Second Course) | 5 | 6 |
| Total, other adverse events | Pembrolizumab Monotherapy (First Course) | 265 | 300 |
| Total, other adverse events | Pembrolizumab + Chemotherapy (First Course) | 266 | 276 |
| Total, other adverse events | Cetuximab + Chemotherapy (Control) | 278 | 287 |
| Total, other adverse events | Pembrolizumab Monotherapy (Second Course) | 6 | 8 |
| Total, other adverse events | Pembrolizumab + Chemotherapy (Second Course) | 6 | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT02358031
GET https://conductscience.org/api/trials/v1/NCT02358031/registered?page=2