Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)
NCT04776148Phase 3Completed
- Lead sponsor
- Merck Sharp & Dohme LLC (Industry)
- Enrollment
- 563 (actual)
- Start date
- 29 Mar 2021
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024
- Last update posted
- 5 Feb 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- pembrolizumab Drug
- lenvatinib Drug
- regorafenib Drug
- TAS-102 (trifluridine and tipiracil) Drug
Conditions and primary outcome
- Colorectal Neoplasms
Primary outcome
Global Cohort: Overall Survival (OS) (Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023)); China Cohort: Overall Survival (OS) (Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024))
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT04776148 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Global Cohort: Overall Survival (OS)
- Time frame
- Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023)
- Measure
- Median
- Unit
- Months
Lenvatinib+Pembrolizumab vs Standard of Care (SOC) TreatmentSuperiority
Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).
- Estimate
- 0.83Hazard Ratio (HR)
- 95% CI, two-sided
- 0.68 to 1.02
- p-value
- 0.0379
- Method
- Log Rank
China Cohort: Overall Survival (OS)
- Time frame
- Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024)
- Measure
- Median
- Unit
- Months
Lenvatinib+Pembrolizumab vs Standard of Care (SOC) TreatmentSuperiority
Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.
- Estimate
- 0.92Hazard Ratio (HR)
- 95% CI, two-sided
- 0.60 to 1.42
- p-value
- 0.3574
- Method
- Log Rank
Serious adverse events
Time frame: Up to approximately 41 months (through End of Trial database cut-off date of 27-Sep-2024)
| Group | Affected | At risk |
|---|---|---|
| Lenvatinib + Pembrolizumab | 117 | 279 |
| Standard Of Care Treatment | 66 | 277 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedLenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 Aug 20
PubMed 38833658 (opens in a new tab)DOI 10.1200/JCO.23.02736 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04776148 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.