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Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

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ClinicalTrials.gov Identifier: NCT03898180
Recruitment Status : Active, not recruiting
First Posted : April 1, 2019
Results First Posted : October 31, 2023
Last Update Posted : February 6, 2024
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Urothelial Carcinoma
Interventions Biological: Pembrolizumab
Drug: Lenvatinib
Drug: Placebo for lenvatinib
Enrollment 487
Recruitment Details  
Pre-assignment Details This results disclosure is based on a data cutoff date of July-26-2021, at which time 267 participants were ongoing in the study.
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Hide Arm/Group Description Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: September [Sep]-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]). Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Period Title: Overall Study
Started 245 242
Treated 241 242
Completed 0 0
Not Completed 245 242
Reason Not Completed
Ongoing in Study             133             134
Withdrawal by Subject             3             2
Death             109             106
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo Total
Hide Arm/Group Description Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]). Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]). Total of all reporting groups
Overall Number of Baseline Participants 245 242 487
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 245 participants 242 participants 487 participants
72.2  (9.3) 72.0  (8.5) 72.1  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 242 participants 487 participants
Female
76
  31.0%
58
  24.0%
134
  27.5%
Male
169
  69.0%
184
  76.0%
353
  72.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 242 participants 487 participants
Hispanic or Latino
15
   6.1%
10
   4.1%
25
   5.1%
Not Hispanic or Latino
209
  85.3%
209
  86.4%
418
  85.8%
Unknown or Not Reported
21
   8.6%
23
   9.5%
44
   9.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 242 participants 487 participants
American Indian or Alaska Native
0
   0.0%
1
   0.4%
1
   0.2%
Asian
74
  30.2%
70
  28.9%
144
  29.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
162
  66.1%
156
  64.5%
318
  65.3%
More than one race
0
   0.0%
1
   0.4%
1
   0.2%
Unknown or Not Reported
9
   3.7%
14
   5.8%
23
   4.7%
Chemotherapy Ineligibility, Combined positive score (CPS),Eastern Cooperative Oncology Group (ECOG)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 242 participants 487 participants
Ineligible for any platinum agents CPS ≥10 ECOG 2
82
  33.5%
81
  33.5%
163
  33.5%
Ineligible for any platinum agents CPS <10 ECOG 2
114
  46.5%
113
  46.7%
227
  46.6%
Cisplatin-ineligible CPS ≥10 ECOG 2
8
   3.3%
8
   3.3%
16
   3.3%
Cisplatin-ineligible CPS ≥10 ECOG 0 or 1
41
  16.7%
40
  16.5%
81
  16.6%
[1]
Measure Description: Participants were classified as: ineligible for cisplatin or any agent. CPS=PD-L1 positive cell (tumor cell, macrophage, lymphocyte; assessed by immunohistochemistry) number divided by total tumor cells expressed as percentage; classified as CPS ≥10 or <10. ECOG 0=fully active, ECOG 1=strenuous activity restricted, ECOG 2=In bed <50% of time; classified as ECOG =2 or 0/1. Per protocol stratification: (1) Ineligible for any platinum agents CPS ≥10 ECOG 2; (2) Ineligible for any platinum agents CPS <10 ECOG 2; (3) Cisplatin-ineligible CPS ≥10 ECOG 2; (4) Cisplatin-ineligible CPS ≥10 ECOG 0 or 1
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR), 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 have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 is presented. Protocol-specified final analysis for this primary outcome measure was performed with an analysis data cut-off date of July-26-2021.
Time Frame Up to ~25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Overall Number of Participants Analyzed 245 242
Median (95% Confidence Interval)
Unit of Measure: Months
4.5
(4.0 to 6.0)
4.0
(2.7 to 5.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab + Lenvatinib, Pembrolizumab + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4107
Comments Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, programmed cell death ligand 1 (PD-L1) CPS, and ECOG performance status (PS).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.72 to 1.14
Estimation Comments Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.
2.Primary Outcome
Title Overall Survival (OS)
Hide Description 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. Protocol-specified final analysis for this primary outcome measure was performed with an analysis data cut-off date of July-26-2021.
Time Frame Up to ~25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Overall Number of Participants Analyzed 245 242
Median (95% Confidence Interval)
Unit of Measure: Months
11.8
(9.1 to 15.1)
12.9
(9.8 to 17.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab + Lenvatinib, Pembrolizumab + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3505
Comments Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.87 to 1.48
Estimation Comments Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description 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) per RECIST 1.1 as assessed by BICR. The percentage of participants who experienced a CR or PR is presented. Protocol-specified final analysis for this secondary outcome measure was performed with an analysis data cut-off date of July-26-2021.
Time Frame Up to ~25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Overall Number of Participants Analyzed 245 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
33.1
(27.2 to 39.3)
28.9
(23.3 to 35.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab + Lenvatinib, Pembrolizumab + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-4.0 to 12.2
Estimation Comments Based on Miettinen & Nurminen method stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description For participants who demonstrated 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) per RECIST 1.1 as assessed by BICR, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions as well as an absolute increase of ≥5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. The DOR as assessed by BICR per RECIST 1.1 for participants who experienced a confirmed CR or PR is presented. Protocol-specified final analysis for this secondary outcome measure was performed with an analysis data cut-off date of July-26-2021.
Time Frame Up to ~25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who experienced a confirmed complete response or partial response.
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Overall Number of Participants Analyzed 81 70
Median (Full Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median, upper limit and lower limit of range could not be reached at time of data cut-off due to insufficient number of responding participants with relapse.
5.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR was defined at the percentage of participants who have a 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) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD]. DCR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. The DCR as assessed by BICR per RECIST 1.1 is presented. Protocol-specified final analysis for this secondary outcome measure was performed with an analysis data cut-off date of July-26-2021.
Time Frame Up to ~25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Overall Number of Participants Analyzed 245 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
66.9
(60.7 to 72.8)
56.2
(49.7 to 62.5)
6.Secondary Outcome
Title Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Hide Description The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented. A higher score indicates a better outcome.
Time Frame Baseline and Up to ~60 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Hide Description The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in GHS (EORTC QLQ-C30 Item 29) & QoL (EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.
Time Frame Up to ~60 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Number of Participants Who Experience an Adverse Event (AE)
Hide Description An AE was defined as 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 therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented. Protocol-specified final analysis for this secondary outcome measure was performed with an analysis data cut-off date of July-26-2021.
Time Frame Up to ~25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment.
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Overall Number of Participants Analyzed 241 242
Measure Type: Count of Participants
Unit of Measure: Participants
234
  97.1%
235
  97.1%
9.Secondary Outcome
Title Number of Participants Who Discontinue Study Treatment Due to an AE
Hide Description An AE was defined as 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 therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented. Protocol-specified final analysis for this secondary outcome measure was performed with an analysis data cut-off date of July-26-2021.
Time Frame Up to ~25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment.
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Overall Number of Participants Analyzed 241 242
Measure Type: Count of Participants
Unit of Measure: Participants
83
  34.4%
44
  18.2%
Time Frame Up to ~25 months
Adverse Event Reporting Description All-Cause Mortality includes all randomized participants. AEs include all randomized participants who received at least one dose of study treatment. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
 
Arm/Group Title Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Hide Arm/Group Description Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]). Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
All-Cause Mortality
Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   109/245 (44.49%)      108/242 (44.63%)    
Hide Serious Adverse Events
Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   132/241 (54.77%)      95/242 (39.26%)    
Blood and lymphatic system disorders     
Anaemia † 1  2/241 (0.83%)  2 6/242 (2.48%)  6
Febrile neutropenia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Cardiac disorders     
Atrial fibrillation † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Cardiac arrest † 1  4/241 (1.66%)  4 0/242 (0.00%)  0
Cardiac failure † 1  4/241 (1.66%)  4 1/242 (0.41%)  1
Cardio-respiratory arrest † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Coronary artery disease † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Myocardial infarction † 1  2/241 (0.83%)  2 1/242 (0.41%)  1
Prinzmetal angina † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Tachycardia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Ventricular tachycardia † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Ear and labyrinth disorders     
Vertigo † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Endocrine disorders     
Hyperthyroidism † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Hypophysitis † 1  1/241 (0.41%)  1 1/242 (0.41%)  1
Hypothyroidism † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Gastrointestinal disorders     
Anal fistula † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Colitis † 1  3/241 (1.24%)  3 3/242 (1.24%)  3
Colitis microscopic † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Colitis ulcerative † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Constipation † 1  2/241 (0.83%)  3 0/242 (0.00%)  0
Diarrhoea † 1  3/241 (1.24%)  4 0/242 (0.00%)  0
Diverticular perforation † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Duodenal obstruction † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Duodenal ulcer haemorrhage † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Dysphagia † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Enterovesical fistula † 1  0/241 (0.00%)  0 2/242 (0.83%)  2
Gastric ulcer † 1  1/241 (0.41%)  1 1/242 (0.41%)  1
Gastrointestinal haemorrhage † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Ileus † 1  4/241 (1.66%)  4 1/242 (0.41%)  1
Immune-mediated enterocolitis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Intestinal fistula † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Intestinal haemorrhage † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Intestinal obstruction † 1  2/241 (0.83%)  2 1/242 (0.41%)  2
Large intestinal haemorrhage † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Mechanical ileus † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Nausea † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Obstructive pancreatitis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Pancreatitis † 1  2/241 (0.83%)  2 0/242 (0.00%)  0
Small intestinal obstruction † 1  1/241 (0.41%)  1 2/242 (0.83%)  2
Stomatitis † 1  1/241 (0.41%)  2 1/242 (0.41%)  1
General disorders     
Asthenia † 1  3/241 (1.24%)  3 1/242 (0.41%)  1
Chest pain † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Death † 1  6/241 (2.49%)  6 3/242 (1.24%)  3
Fatigue † 1  4/241 (1.66%)  4 1/242 (0.41%)  1
General physical health deterioration † 1  2/241 (0.83%)  2 1/242 (0.41%)  1
Hernia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Hyperthermia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Impaired healing † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Multiple organ dysfunction syndrome † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Oedema peripheral † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Pyrexia † 1  1/241 (0.41%)  1 4/242 (1.65%)  4
Hepatobiliary disorders     
Cholangitis acute † 1  1/241 (0.41%)  2 0/242 (0.00%)  0
Cholecystitis † 1  2/241 (0.83%)  2 1/242 (0.41%)  1
Cholecystitis acute † 1  2/241 (0.83%)  2 0/242 (0.00%)  0
Hepatitis acute † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Hepatotoxicity † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Immune-mediated hepatitis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Jaundice cholestatic † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Infections and infestations     
Abdominal abscess † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Appendicitis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Appendicitis perforated † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Atypical pneumonia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
COVID-19 † 1  2/241 (0.83%)  2 1/242 (0.41%)  1
COVID-19 pneumonia † 1  3/241 (1.24%)  3 3/242 (1.24%)  3
Campylobacter infection † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Cellulitis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Device related infection † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Diverticulitis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Encephalitis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Gastroenteritis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Infection † 1  1/241 (0.41%)  1 1/242 (0.41%)  1
Infectious pleural effusion † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Kidney infection † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Liver abscess † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Pelvic abscess † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Perirectal abscess † 1  1/241 (0.41%)  1 1/242 (0.41%)  1
Peritonitis † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Pneumocystis jirovecii pneumonia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Pneumonia † 1  9/241 (3.73%)  9 4/242 (1.65%)  4
Postoperative wound infection † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Pyelonephritis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Pyelonephritis acute † 1  1/241 (0.41%)  1 2/242 (0.83%)  2
Respiratory tract infection † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Sepsis † 1  3/241 (1.24%)  3 4/242 (1.65%)  5
Septic shock † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Skin infection † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Urinary tract infection † 1  8/241 (3.32%)  8 9/242 (3.72%)  9
Urinary tract infection bacterial † 1  1/241 (0.41%)  1 1/242 (0.41%)  1
Urosepsis † 1  1/241 (0.41%)  1 2/242 (0.83%)  2
Injury, poisoning and procedural complications     
Fall † 1  2/241 (0.83%)  2 0/242 (0.00%)  0
Femoral neck fracture † 1  2/241 (0.83%)  2 1/242 (0.41%)  1
Femur fracture † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Hip fracture † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Multiple injuries † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Subdural haematoma † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Urinary tract stoma complication † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Vascular access site occlusion † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Wound haematoma † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Investigations     
Blood creatinine increased † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Hepatic enzyme increased † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Pancreatic enzymes increased † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Platelet count decreased † 1  3/241 (1.24%)  3 0/242 (0.00%)  0
SARS-CoV-2 test positive † 1  0/241 (0.00%)  0 2/242 (0.83%)  2
Metabolism and nutrition disorders     
Cachexia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Decreased appetite † 1  2/241 (0.83%)  3 0/242 (0.00%)  0
Dehydration † 1  3/241 (1.24%)  3 2/242 (0.83%)  2
Diabetic ketoacidosis † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Hypercalcaemia † 1  1/241 (0.41%)  1 2/242 (0.83%)  2
Hyperglycaemia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Hyperuricaemia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Hypoglycaemia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Hypokalaemia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Hyponatraemia † 1  2/241 (0.83%)  2 0/242 (0.00%)  0
Metabolic acidosis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain † 1  2/241 (0.83%)  2 1/242 (0.41%)  1
Bone lesion † 1  1/241 (0.41%)  1 1/242 (0.41%)  1
Myositis † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Pain in extremity † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Pathological fracture † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Polymyalgia rheumatica † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Bladder neoplasm † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Cancer pain † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Lung neoplasm malignant † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Pancreatic carcinoma † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Parathyroid tumour benign † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Tumour pain † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Nervous system disorders     
Ataxia † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Cerebral infarction † 1  0/241 (0.00%)  0 2/242 (0.83%)  2
Cerebrovascular accident † 1  0/241 (0.00%)  0 2/242 (0.83%)  2
Dizziness † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Encephalopathy † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Epilepsy † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Facial nerve disorder † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Haemorrhagic stroke † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Headache † 1  2/241 (0.83%)  2 0/242 (0.00%)  0
Ischaemic stroke † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Loss of consciousness † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Metabolic encephalopathy † 1  2/241 (0.83%)  2 0/242 (0.00%)  0
Myasthenia gravis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Parkinsonism † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Peripheral sensory neuropathy † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Sciatica † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Somnolence † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Spinal cord compression † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Transient ischaemic attack † 1  2/241 (0.83%)  2 0/242 (0.00%)  0
Product Issues     
Device dislocation † 1  2/241 (0.83%)  3 3/242 (1.24%)  3
Device occlusion † 1  2/241 (0.83%)  2 0/242 (0.00%)  0
Lead dislodgement † 1  0/241 (0.00%)  0 1/242 (0.41%)  2
Psychiatric disorders     
Confusional state † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Delirium † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury † 1  11/241 (4.56%)  16 4/242 (1.65%)  4
Bladder mass † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Bladder obstruction † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Chronic kidney disease † 1  2/241 (0.83%)  2 2/242 (0.83%)  2
Haematuria † 1  5/241 (2.07%)  6 4/242 (1.65%)  4
Hydronephrosis † 1  3/241 (1.24%)  3 1/242 (0.41%)  1
Nephritis † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Perinephric collection † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Postrenal failure † 1  0/241 (0.00%)  0 2/242 (0.83%)  2
Proteinuria † 1  3/241 (1.24%)  3 0/242 (0.00%)  0
Renal failure † 1  1/241 (0.41%)  1 2/242 (0.83%)  2
Renal impairment † 1  1/241 (0.41%)  1 2/242 (0.83%)  2
Urinary bladder haemorrhage † 1  0/241 (0.00%)  0 2/242 (0.83%)  3
Urinary retention † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Urinary tract obstruction † 1  1/241 (0.41%)  1 1/242 (0.41%)  1
Reproductive system and breast disorders     
Pelvic pain † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Vaginal haemorrhage † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1  0/241 (0.00%)  0 4/242 (1.65%)  4
Dyspnoea † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Pleural effusion † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Pneumonia aspiration † 1  4/241 (1.66%)  4 0/242 (0.00%)  0
Pneumonitis † 1  3/241 (1.24%)  3 3/242 (1.24%)  3
Pulmonary embolism † 1  1/241 (0.41%)  1 2/242 (0.83%)  2
Respiratory failure † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Rash papular † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Stevens-Johnson syndrome † 1  2/241 (0.83%)  2 0/242 (0.00%)  0
Vascular disorders     
Blood pressure fluctuation † 1  1/241 (0.41%)  1 0/242 (0.00%)  0
Embolism † 1  0/241 (0.00%)  0 1/242 (0.41%)  1
Hypertension † 1  4/241 (1.66%)  4 0/242 (0.00%)  0
Hypotension † 1  0/241 (0.00%)  0 2/242 (0.83%)  2
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab + Lenvatinib Pembrolizumab + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   225/241 (93.36%)      216/242 (89.26%)    
Blood and lymphatic system disorders     
Anaemia † 1  37/241 (15.35%)  45 49/242 (20.25%)  55
Endocrine disorders     
Hyperthyroidism † 1  15/241 (6.22%)  16 11/242 (4.55%)  12
Hypothyroidism † 1  88/241 (36.51%)  97 21/242 (8.68%)  23
Gastrointestinal disorders     
Abdominal pain † 1  20/241 (8.30%)  25 16/242 (6.61%)  16
Constipation † 1  38/241 (15.77%)  44 25/242 (10.33%)  28
Diarrhoea † 1  61/241 (25.31%)  102 46/242 (19.01%)  64
Nausea † 1  48/241 (19.92%)  62 38/242 (15.70%)  41
Stomatitis † 1  15/241 (6.22%)  20 7/242 (2.89%)  10
Vomiting † 1  35/241 (14.52%)  40 20/242 (8.26%)  23
General disorders     
Asthenia † 1  47/241 (19.50%)  53 28/242 (11.57%)  34
Fatigue † 1  48/241 (19.92%)  51 50/242 (20.66%)  51
Mucosal inflammation † 1  18/241 (7.47%)  19 8/242 (3.31%)  8
Oedema peripheral † 1  24/241 (9.96%)  27 23/242 (9.50%)  24
Pyrexia † 1  20/241 (8.30%)  25 31/242 (12.81%)  39
Infections and infestations     
Urinary tract infection † 1  50/241 (20.75%)  66 36/242 (14.88%)  41
Investigations     
Alanine aminotransferase increased † 1  19/241 (7.88%)  26 14/242 (5.79%)  16
Amylase increased † 1  23/241 (9.54%)  32 23/242 (9.50%)  31
Aspartate aminotransferase increased † 1  18/241 (7.47%)  23 14/242 (5.79%)  15
Blood alkaline phosphatase increased † 1  15/241 (6.22%)  18 16/242 (6.61%)  18
Blood creatinine increased † 1  23/241 (9.54%)  25 14/242 (5.79%)  17
Lipase increased † 1  33/241 (13.69%)  39 22/242 (9.09%)  28
Platelet count decreased † 1  16/241 (6.64%)  22 7/242 (2.89%)  8
Weight decreased † 1  42/241 (17.43%)  43 15/242 (6.20%)  16
Metabolism and nutrition disorders     
Decreased appetite † 1  68/241 (28.22%)  82 35/242 (14.46%)  39
Hypoalbuminaemia † 1  18/241 (7.47%)  21 9/242 (3.72%)  9
Hyponatraemia † 1  17/241 (7.05%)  20 15/242 (6.20%)  16
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  26/241 (10.79%)  34 23/242 (9.50%)  26
Back pain † 1  22/241 (9.13%)  24 15/242 (6.20%)  16
Pain in extremity † 1  14/241 (5.81%)  15 6/242 (2.48%)  6
Nervous system disorders     
Headache † 1  20/241 (8.30%)  24 13/242 (5.37%)  14
Psychiatric disorders     
Insomnia † 1  9/241 (3.73%)  9 16/242 (6.61%)  17
Renal and urinary disorders     
Haematuria † 1  29/241 (12.03%)  31 27/242 (11.16%)  36
Proteinuria † 1  98/241 (40.66%)  140 60/242 (24.79%)  80
Respiratory, thoracic and mediastinal disorders     
Cough † 1  10/241 (4.15%)  10 15/242 (6.20%)  20
Dysphonia † 1  35/241 (14.52%)  44 2/242 (0.83%)  2
Dyspnoea † 1  19/241 (7.88%)  20 11/242 (4.55%)  12
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome † 1  24/241 (9.96%)  27 0/242 (0.00%)  0
Pruritus † 1  30/241 (12.45%)  37 41/242 (16.94%)  50
Rash † 1  30/241 (12.45%)  37 19/242 (7.85%)  23
Vascular disorders     
Hypertension † 1  95/241 (39.42%)  119 20/242 (8.26%)  26
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Publications of Results:
Matsubara N, de Wit R, Balar AV, Siefker-Radtke AO, Zolnierek J, Csoszi T, Shin SJ, Park SH, Atduev V, Gumus M, Su YL, Karaca SB, Cutuli HJ, Sendur MAN, Shen L, O'Hara K, Okpara CE, Franco S, Moreno BH, Grivas P, Loriot Y. Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial. Eur Urol. 2024 Mar;85(3):229-238. doi: 10.1016/j.eururo.2023.08.012. Epub 2023 Sep 29.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT03898180    
Other Study ID Numbers: 7902-011
MK-7902-011 ( Other Identifier: Merck )
E7080-G000-317 ( Other Identifier: Eisai )
LEAP-011 ( Other Identifier: Merck )
194808 ( Registry Identifier: JAPIC-CTI )
2018-003752-21 ( EudraCT Number )
First Submitted: March 29, 2019
First Posted: April 1, 2019
Results First Submitted: October 6, 2023
Results First Posted: October 31, 2023
Last Update Posted: February 6, 2024