Trial · NCT02811861
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
NCT02811861, Phase 3, Active not recruiting, Eisai Inc.; results first posted 2021-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma. Trials, record NCT02811861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02811861
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
- NCT number
- NCT02811861
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,069 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Renal Cell Carcinoma
- Interventions
- Lenvatinib, Everolimus, Pembrolizumab, Sunitinib
- First posted
- 2016-06-23
- Last updated
- 2026-02-23
- Other registries' IDs
- eudract:2016-000916-14
- Results first posted
- 2021-09-24
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) by Independent Imaging Review (IIR) | From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) | PFS assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 69 months | ORR is defined as the proportion of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by IIR using RECIST 1.1. CR is defined as disappearance of all (targeted and non-target \[NT\]) lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026). |
| Secondary | Overall Survival (OS) | Up to approximately 69 months | OS is defined as the time from the date of randomization to the date of death from any cause. Participants who were lost to follow-up and those who were alive at the data cutoff date were censored, either at the last date the participant was last known alive or at the data cutoff date, whichever occurred first. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026). |
| Secondary | Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to approximately 69 months | TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug.An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026). |
| Secondary | Number of Participants Who Discontinued Treatment Due to Toxicity | Up to approximately 69 months | Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026. |
| Secondary | Time to Treatment Failure Due to Toxicity | Up to approximately 69 months | Time to treatment failure due to toxicity is defined as time from the date of randomization to the date that a participant discontinued study treatment due to TEAEs. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026). |
| Secondary | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Up to approximately 69 months | The FKSI-DRS consisted of 9 items that experts and participants had indicated are important targets for the treatment of advanced kidney cancer, and that clinical experts had indicated are primarily disease-related, as opposed to treatment-related. Symptoms assessed on the FKSI-DRS included lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or hematuria. Each item was scored on a 5-point Likert-type scale (0 = not at all; 4 = very much) where total score ranged from 0 (worst) to 36 (best), where higher scores correspond to better outcomes. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026). |
| Secondary | HRQoL Assessed by European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Score | Up to approximately 69 months | EORTC QLQ-C30 is a questionnaire including 30 questions that rate the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. For the overall HRQoL and functioning scales, a higher score is correlated with better HRQoL, whereas a higher score represents worse HRQoL for symptom scales. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026) |
| Secondary | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Score | Up to approximately 69 months | EQ-5D-3L is a health profile questionnaire consisting of the EQ-5D descriptive system and the EuroQol visual analog scale (EQ-VAS). For the EQ-5D, participants rate 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) at 1 of 3 levels (1=no problems; 2=some problems; 3=extreme problems). The EQ-5D Health Utilities Index (HUI) is derived from the five dimensions of the EQ-5D, using country-specific preference weights (tariffs) to summarize how good or bad each health state is on a scale from 1 (full health) to \<0 (worse health/dead). The EQ-VAS measures self-rated global health status using a vertically oriented VAS, where 100 represents the "best imaginable health state" and 0 represents the "worst imaginable health state." Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026) |
| Secondary | PFS on Next-line of Therapy (PFS2) | Up to approximately 69 months | PFS2 is defined as the time from randomization to disease progression as assessed by investigator on next-line treatment or death from any cause (whichever occurred first). Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) by Independent Imaging Review (IIR) | From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) | The FAS included all randomized participants regardless of the treatment actually received. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 69 months | |||
| SECONDARY | Overall Survival (OS) | Up to approximately 69 months | |||
| SECONDARY | Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to approximately 69 months | |||
| SECONDARY | Number of Participants Who Discontinued Treatment Due to Toxicity | Up to approximately 69 months | |||
| SECONDARY | Time to Treatment Failure Due to Toxicity | Up to approximately 69 months | |||
| SECONDARY | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Up to approximately 69 months | |||
| SECONDARY | HRQoL Assessed by European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Score | Up to approximately 69 months | |||
| SECONDARY | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Score | Up to approximately 69 months | |||
| SECONDARY | PFS on Next-line of Therapy (PFS2) | Up to approximately 69 months |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) by Independent Imaging Review (IIR) | Lenvatinib 18 mg Plus Everolimus 5 mg | 14.7 | 95% Confidence Interval 11.1 to 16.7 | months | |
| Progression-free Survival (PFS) by Independent Imaging Review (IIR) | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 23.9 | 95% Confidence Interval 20.8 to 27.7 | months | |
| Progression-free Survival (PFS) by Independent Imaging Review (IIR) | Sunitinib 50 mg | 9.2 | 95% Confidence Interval 6.0 to 11.0 | months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenvatinib 18 mg Plus Everolimus 5 mg | 357 | |
| Overall Study | STARTED | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 355 | |
| Overall Study | STARTED | Sunitinib 50 mg | 357 | |
| Overall Study | Treated | Lenvatinib 18 mg Plus Everolimus 5 mg | 355 | |
| Overall Study | Treated | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 352 | |
| Overall Study | Treated | Sunitinib 50 mg | 340 | |
| Overall Study | COMPLETED | Lenvatinib 18 mg Plus Everolimus 5 mg | 0 | |
| Overall Study | COMPLETED | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 0 | |
| Overall Study | COMPLETED | Sunitinib 50 mg | 0 | |
| Overall Study | NOT COMPLETED | Lenvatinib 18 mg Plus Everolimus 5 mg | 357 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,269
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Lenvatinib 18 mg Plus Everolimus 5 mg | 233 | 355 | |
| other | Diarrhoea | Gastrointestinal disorders | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 214 | 352 | |
| other | Diarrhoea | Gastrointestinal disorders | Sunitinib 50 mg | 166 | 340 | |
| other | Stomatitis | Gastrointestinal disorders | Lenvatinib 18 mg Plus Everolimus 5 mg | 169 | 355 | |
| other | Stomatitis | Gastrointestinal disorders | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 122 | 352 | |
| other | Stomatitis | Gastrointestinal disorders | Sunitinib 50 mg | 131 | 340 | |
| other | Nausea | Gastrointestinal disorders | Lenvatinib 18 mg Plus Everolimus 5 mg | 139 | 355 | |
| other | Nausea | Gastrointestinal disorders | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 125 | 352 | |
| other | Nausea | Gastrointestinal disorders | Sunitinib 50 mg | 113 | 340 | |
| other | Vomiting | Gastrointestinal disorders | Lenvatinib 18 mg Plus Everolimus 5 mg | 107 | 355 |
1 to 10 of 1,269Source ClinicalTrials.gov
See all 1,269 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenvatinib 18 mg Plus Everolimus 5 mg | 119 | 355 |
| Total, all-cause mortality | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 78 | 352 |
| Total, all-cause mortality | Sunitinib 50 mg | 99 | 340 |
| Total, other adverse events | Lenvatinib 18 mg Plus Everolimus 5 mg | 353 | 355 |
| Total, other adverse events | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 351 | 352 |
| Total, other adverse events | Sunitinib 50 mg | 332 | 340 |
| Total, serious adverse events | Lenvatinib 18 mg Plus Everolimus 5 mg | 164 | 355 |
| Total, serious adverse events | Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 178 | 352 |
| Total, serious adverse events | Sunitinib 50 mg | 113 | 340 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02811861
GET https://conductscience.org/api/trials/v1/NCT02811861/events?page=2