Trial · NCT04428151

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

NCT04428151, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2025-05-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009). Trials, record NCT04428151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04428151

On this page

Trial

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

Title: Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)
NCT number: NCT04428151
Status: Completed
Phases: Phase 2
Enrollment: 408 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Squamous Cell Carcinoma of Head and Neck
Interventions: Lenvatinib, Pembrolizumab, Docetaxel, Capecitabine, Paclitaxel, Cetuximab, Lenvatinib
First posted: 2020-06-11
Last updated: 2025-12-04
Other registries' IDs: eudract:2019-000569-19
Results first posted: 2025-05-25

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	Up to approximately 45 months	OS was defined as the time from randomization to death due to any cause.
Secondary	Progression-Free Survival (PFS)	Up to approximately 45 months	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. 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 must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD.
Secondary	Objective Response Rate (ORR)	Up to approximately 45 months	ORR was defined as the percentage of participants who had a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Secondary	Duration of Response (DOR)	Up to approximately 45 months	DOR was defined as the time from the first documented evidence of complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR.
Secondary	Number of Participants Who Experienced One or More Adverse Events (AEs)	Up to approximately 5 years	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE was presented.
Secondary	Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)	Up to approximately 5 years	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE was presented.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	Up to approximately 45 months	The analysis population consisted of all participants who were randomized prior to the primary completion data cut-off. Per protocol, participants who received lenvatinib monotherapy were not analyzed.	Months	MEDIAN
SECONDARY	Progression-Free Survival (PFS)	Up to approximately 45 months	The analysis population consisted of all participants randomized by the primary completion data cut-off. Per protocol, participants who received lenvatinib monotherapy were not analyzed.	Months	MEDIAN
SECONDARY	Objective Response Rate (ORR)	Up to approximately 45 months	The analysis population consisted of all participants randomized by the primary completion data cut-off. Per protocol, participants who received lenvatinib monotherapy were not analyzed.	Percentage of Participants	NUMBER
SECONDARY	Duration of Response (DOR)	Up to approximately 45 months	The analysis population consisted of all participants randomized by the primary completion data cut-off who experienced a confirmed CR or PR. Per protocol, participants who received lenvatinib monotherapy were not analyzed.	Months	MEDIAN
SECONDARY	Number of Participants Who Experienced One or More Adverse Events (AEs)	Up to approximately 5 years
SECONDARY	Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)	Up to approximately 5 years

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Overall Survival (OS)	Lenvatinib + Pembrolizumab	8.4	95% Confidence Interval 6.9 to 10.3	Months
Overall Survival (OS)	SOC Chemotherapy	11.3	95% Confidence Interval 9.8 to 14.4	Months
Progression-Free Survival (PFS)	Lenvatinib + Pembrolizumab	3.0	95% Confidence Interval 2.8 to 3.9	Months
Progression-Free Survival (PFS)	SOC Chemotherapy	2.8	95% Confidence Interval 2.6 to 4.0	Months
Objective Response Rate (ORR)	Lenvatinib + Pembrolizumab	13.9	95% Confidence Interval 8.7 to 20.6	Percentage of Participants
Objective Response Rate (ORR)	SOC Chemotherapy	20.4	95% Confidence Interval 14.1 to 28.0	Percentage of Participants
Duration of Response (DOR)	Lenvatinib + Pembrolizumab	4.1	95% Confidence Interval 3.6 to 7.9	Months
Duration of Response (DOR)	SOC Chemotherapy	5.9	95% Confidence Interval 3.7 to 11.8	Months

Source ClinicalTrials.gov

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lenvatinib + Pembrolizumab	144
Overall Study	STARTED	SOC Chemotherapy	142
Overall Study	STARTED	Lenvatinib Monotherapy	88
Overall Study	Treated	Lenvatinib + Pembrolizumab	143
Overall Study	Treated	SOC Chemotherapy	140
Overall Study	Treated	Lenvatinib Monotherapy	88
Overall Study	Switched Over to Pembrolizumab + Lenvatinib	Lenvatinib + Pembrolizumab	0
Overall Study	Switched Over to Pembrolizumab + Lenvatinib	SOC Chemotherapy	61
Overall Study	Switched Over to Pembrolizumab + Lenvatinib	Lenvatinib Monotherapy	18
Overall Study	Switched Over to Pembrolizumab	Lenvatinib + Pembrolizumab	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events1,632

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	Lenvatinib + Pembrolizumab	20	143	24
other	Anaemia	Blood and lymphatic system disorders	SOC Chemotherapy	37	140	40
other	Anaemia	Blood and lymphatic system disorders	Lenvatinib Monotherapy	13	88	18
other	Anaemia	Blood and lymphatic system disorders	SOC Chemotherapy Switched Over to Pembrolizumab+Lenvatinib	4	61	4
other	Anaemia	Blood and lymphatic system disorders	SOC Chemotherapy Switched Over to Pembrolizumab	0	1	0
other	Anaemia	Blood and lymphatic system disorders	Lenvatinib Switched Over to Pembrolizumab+Lenvatinib	2	18	2
other	Necrotic lymphadenopathy	Blood and lymphatic system disorders	Lenvatinib + Pembrolizumab	0	143	0
other	Necrotic lymphadenopathy	Blood and lymphatic system disorders	SOC Chemotherapy	0	140	0
other	Necrotic lymphadenopathy	Blood and lymphatic system disorders	Lenvatinib Monotherapy	0	88	0
other	Necrotic lymphadenopathy	Blood and lymphatic system disorders	SOC Chemotherapy Switched Over to Pembrolizumab+Lenvatinib	0	61	0

1 to 10 of 1,632Source ClinicalTrials.gov

See all 1,632 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lenvatinib + Pembrolizumab	103	144
Total, all-cause mortality	SOC Chemotherapy	42	142
Total, all-cause mortality	Lenvatinib Monotherapy	50	88
Total, all-cause mortality	SOC Chemotherapy Switched Over to Pembrolizumab+Lenvatinib	44	61
Total, all-cause mortality	SOC Chemotherapy Switched Over to Pembrolizumab	1	1
Total, all-cause mortality	Lenvatinib Switched Over to Pembrolizumab+Lenvatinib	10	18
Total, other adverse events	Lenvatinib + Pembrolizumab	139	143
Total, other adverse events	SOC Chemotherapy	135	140
Total, other adverse events	Lenvatinib Monotherapy	80	88
Total, other adverse events	SOC Chemotherapy Switched Over to Pembrolizumab+Lenvatinib	55	61

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33300372	DERIVED

Source 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 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.

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/NCT04428151

GET https://conductscience.org/api/trials/v1/NCT04428151/events?page=2

API reference For AI assistants