Trial Outcomes & Findings for A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension (NCT NCT05523323)

Last Updated: 2025-04-18

Results Overview

ORR was defined as the percentage of participants who have 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, taking as reference the baseline sum diameters) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 were reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

112 participants

Primary outcome timeframe

Up to approximately 33 months

Results posted on

2025-04-18

Participant Flow

A total of 112 Chinese participants were randomized in the China extension study. Of 112 Chinese participants, 57 participants were randomized in the global portion of the MK-7902-010 (NCT04199104) study and 56 participants were randomized in the China extension portion.

Participant milestones

Participant milestones
Measure	Pembrolizumab + Lenvatinib Participants received lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).	Pembrolizumab + Placebo Participants received lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).
Overall Study STARTED	61	51
Overall Study Treated	61	50
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	61	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab + Lenvatinib Participants received lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).	Pembrolizumab + Placebo Participants received lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).
Overall Study Death	26	21
Overall Study Ongoing participants	35	30

Baseline Characteristics

A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab + Lenvatinib n=61 Participants Participants received lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).	Pembrolizumab + Placebo n=51 Participants Participants received lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).	Total n=112 Participants Total of all reporting groups
Age, Continuous	59.9 Years STANDARD_DEVIATION 9.4 • n=5 Participants	58.4 Years STANDARD_DEVIATION 11.0 • n=7 Participants	59.2 Years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	48 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants	45 Participants n=7 Participants	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	61 Participants n=5 Participants	51 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 33 months

Population: All randomized Chinese participants

Outcome measures

Outcome measures
Measure	Pembrolizumab + Lenvatinib n=61 Participants Participants received lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).	Pembrolizumab + Placebo n=51 Participants Participants received lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	39.3 Percentage of participants Interval 27.1 to 52.7	9.8 Percentage of participants Interval 3.3 to 21.4

PRIMARY outcome

Timeframe: Up to approximately 33 months

Population: All randomized Chinese participants.

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs 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 must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Lenvatinib n=61 Participants Participants received lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).	Pembrolizumab + Placebo n=51 Participants Participants received lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	7.0 Months Interval 4.1 to 8.7	1.5 Months Interval 1.4 to 1.8

PRIMARY outcome

Timeframe: Up to approximately 33 months

Population: All randomized Chinese participants

OS was the time from randomization to death due to any cause.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Lenvatinib n=61 Participants Participants received lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).	Pembrolizumab + Placebo n=51 Participants Participants received lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).
Overall Survival (OS)	10.9 Months Interval 8.7 to 17.5	11.9 Months Interval 7.4 to 14.1

SECONDARY outcome

Timeframe: Up to approximately 33 months

Population: All randomized Chinese participants with a confirmed CR or PR.

For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Lenvatinib n=24 Participants Participants received lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).	Pembrolizumab + Placebo n=5 Participants Participants received lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (approximately 24 months). Per Amendment (AM) 5, (effective date: 16-Aug-2023), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year).
Duration of Response (DOR)	8.3 Months Interval 4.6 to NA = Upper limit of 95%CI for DOR could not be reached due to insufficient number of participants with a response.	NA Months Interval 5.6 to NA = Median and upper limit of 95%CI for DOR could not be reached due to insufficient number of participants with a response.

SECONDARY outcome

Timeframe: Up to approximately 52 months

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Number of participants who experienced an AE will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 52 months

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab + Lenvatinib - First Course

Serious events: 31 serious events

Other events: 56 other events

Deaths: 26 deaths

Pembrolizumab + Placebo - First Course

Serious events: 17 serious events

Other events: 40 other events

Deaths: 21 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER