Trial Outcomes & Findings for Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) (NCT NCT03884101)

Last Updated: 2026-02-02

Results Overview

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. The PFS of pMMR participants was presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

842 participants

Primary outcome timeframe

Up to approximately 44 months

Results posted on

2026-02-02

Participant Flow

Of the 842 total participants randomized in the MK-7902-001 global study, 66 were also randomized in the China extension study for MK-7902-001 (NCT04865289).

Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.

Participant milestones

Participant milestones
Measure	Lenvatinib + Pembrolizumab Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Overall Study STARTED	420	422
Overall Study Treated	420	411
Overall Study Received a Second Course of Pembrolizumab	17	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	420	422

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenvatinib + Pembrolizumab Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Overall Study Death	234	248
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	98	126
Overall Study Sponsor Decision	79	32
Overall Study Withdrawal by Subject	8	15

Baseline Characteristics

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenvatinib + Pembrolizumab n=420 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=422 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.	Total n=842 Participants Total of all reporting groups
Age, Continuous	62.5 Years STANDARD_DEVIATION 10.1 • n=13 Participants	64.0 Years STANDARD_DEVIATION 9.1 • n=15 Participants	63.3 Years STANDARD_DEVIATION 9.7 • n=28 Participants
Sex: Female, Male Female	420 Participants n=13 Participants	422 Participants n=15 Participants	842 Participants n=28 Participants
Sex: Female, Male Male	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	64 Participants n=13 Participants	67 Participants n=15 Participants	131 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	347 Participants n=13 Participants	343 Participants n=15 Participants	690 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=13 Participants	12 Participants n=15 Participants	21 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Asian	114 Participants n=13 Participants	102 Participants n=15 Participants	216 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	1 Participants n=15 Participants	1 Participants n=28 Participants
Race (NIH/OMB) Black or African American	10 Participants n=13 Participants	14 Participants n=15 Participants	24 Participants n=28 Participants
Race (NIH/OMB) White	288 Participants n=13 Participants	300 Participants n=15 Participants	588 Participants n=28 Participants
Race (NIH/OMB) More than one race	8 Participants n=13 Participants	5 Participants n=15 Participants	13 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=0	250 Participants n=13 Participants	240 Participants n=15 Participants	490 Participants n=28 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=1	170 Participants n=13 Participants	182 Participants n=15 Participants	352 Participants n=28 Participants
Prior Chemotherapy and/or Chemoradiation Yes	74 Participants n=13 Participants	68 Participants n=15 Participants	142 Participants n=28 Participants
Prior Chemotherapy and/or Chemoradiation No	346 Participants n=13 Participants	354 Participants n=15 Participants	700 Participants n=28 Participants
Mismatch Repair (MMR) Status dMMR	100 Participants n=13 Participants	100 Participants n=15 Participants	200 Participants n=28 Participants
Mismatch Repair (MMR) Status pMMR	320 Participants n=13 Participants	322 Participants n=15 Participants	642 Participants n=28 Participants

PRIMARY outcome

Timeframe: Up to approximately 44 months

Population: All randomized pMMR participants were analyzed according to the treatment arm to which they were randomized.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=320 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=322 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Progression-free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants	9.6 Months Interval 8.2 to 11.9	10.2 Months Interval 8.4 to 10.4

PRIMARY outcome

Timeframe: Up to approximately 44 months

Population: All randomized participants were analyzed according to the treatment arm to which they were randomized.

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. The PFS of all randomized participants was presented.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=420 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=422 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants	12.5 Months Interval 10.3 to 15.1	10.2 Months Interval 8.4 to 10.4

PRIMARY outcome

Timeframe: Up to approximately 51 months

Population: All randomized pMMR participants were analyzed according to the treatment arm to which they were randomized.

OS was measured from the time of randomization up 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 pMMR participants is presented.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=320 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=322 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Overall Survival (OS) in pMMR Participants	30.9 Months Interval 25.4 to 37.7	29.4 Months Interval 26.2 to 35.4

PRIMARY outcome

Timeframe: Up to approximately 51 months

Population: All randomized participants were analyzed according to the treatment arm to which they were randomized.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=420 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=422 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
OS in All Randomized Participants	37.7 Months Interval 32.2 to 43.6	32.1 Months Interval 27.2 to 35.7

SECONDARY outcome

Timeframe: Up to approximately 51 months

Population: Per protocol, all randomized pMMR participants with measurable disease at the baseline scan were analyzed according to the treatment arm to which they were randomized.

ORR was defined as the percentage of participants 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) as assessed using RECIST 1.1. The percentage of pMMR participants who experienced a CR or PR is presented.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=318 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=317 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants	50.9 Percentage of Participants Interval 45.3 to 56.6	55.2 Percentage of Participants Interval 49.5 to 60.8

SECONDARY outcome

Timeframe: Up to approximately 51 months

Population: Per protocol, all randomized participants with measurable disease at the baseline scan were analyzed according to the treatment arm to which they were randomized.

ORR was defined as the percentage of participants who had a CR: Disappearance of all target lesions or a PR: At least a 30% decrease in the sum of diameters of target lesions as assessed using RECIST 1.1. The percentage of all randomized participants who experienced a CR or PR is presented.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=418 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=416 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants	56.0 Percentage of Participants Interval 51.1 to 60.8	56.0 Percentage of Participants Interval 51.1 to 60.8

SECONDARY outcome

Timeframe: Baseline and up to approximately 18 weeks

Population: All randomized pMMR participants who had at least one assessment available for EORTC QLQ-C30 and received at least one dose of the study intervention were analyzed.

The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of quality of life (QoL): one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=318 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=310 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Mean Change From Baseline in the Global Health Status/Quality of Life Score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR Participants	-5.10 Scores on a scale Interval -7.76 to -2.45	-1.34 Scores on a scale Interval -4.0 to 1.32

SECONDARY outcome

Timeframe: Baseline and up to approximately 18 weeks

Population: All randomized participants who had at least one assessment available for EORTC QLQ-C30 and received at least one dose of the study intervention were analyzed.

The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of QoL: one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=415 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=403 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Mean Change From Baseline in the Global Health Status/Quality of Life Score of the EORTC QLQ-C30 in All Randomized Participants	-4.52 Scores on a scale Interval -6.84 to -2.2	-2.22 Scores on a scale Interval -4.6 to 0.15

SECONDARY outcome

Timeframe: Up to approximately 68 months

Population: All randomized participants who received at least one dose of study intervention were analyzed.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). Per protocol, the number of participants who experienced one or more AEs was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=420 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=411 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Number of Participants Who Experienced an Adverse Event (AE)	418 Participants	405 Participants

SECONDARY outcome

Timeframe: Up to approximately 68 months

Population: All randomized participants who received at least one dose of study intervention were analyzed.

An SAE was an AE that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in persistent or significant disability, was a congenital birth defect, or was another important medical event. Per protocol, the number of participants who experienced one or more SAEs was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=420 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=411 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Number of Participants Who Experienced a Serious Adverse Event (SAE)	230 Participants	84 Participants

SECONDARY outcome

Timeframe: Up to approximately 68 months

Population: All randomized participants who received at least one dose of study intervention were analyzed.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immune-related AEs (irAEs) were AEs that were considered immune-mediated or potentially immune-mediated and are well-documented for pembrolizumab. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. Per protocol, the number of participants who experienced one or more irAEs was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=420 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=411 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Number of Participants Who Experienced an Immune-Related Adverse Event (irAE)	316 Participants	56 Participants

SECONDARY outcome

Timeframe: Up to approximately 68 months

Population: All randomized participants who received at least one dose of study intervention were analyzed.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). Per protocol, the number of participants who discontinued any study intervention (pembrolizumab and/or lenvatinib or paclitaxel and/or carboplatin) due to an AE was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=420 Participants Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression.	Paclitaxel + Carboplatin n=411 Participants Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion.
Number of Participants Who Discontinued Study Intervention Due to an AE	203 Participants	80 Participants

Adverse Events

First Course: Lenvatinib + Pembrolizumab

Serious events: 230 serious events

Other events: 416 other events

Deaths: 233 deaths

Paclitaxel + Carboplatin

Serious events: 84 serious events

Other events: 397 other events

Deaths: 253 deaths

Second Course: Lenvatinib + Pembrolizumab

Serious events: 3 serious events

Other events: 15 other events

Deaths: 3 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 will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER