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NCT03797326 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 611
- Enrollment target
NCT03797326: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT03797326 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 611 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (359% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03797326, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 611 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.
Primary Outcome
ORR was defined as the percentage of participants who had a best overall response of either 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 as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 611 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2024-10-28 |
| Phase | Phase 2 |
What the finished NCT03797326 record still lists
NCT03797326 is an interventional study that assigns participants to a tested intervention. The registered 611 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (359% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03797326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03797326 about?
NCT03797326 is a clinical study titled "Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)". The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract c...
What is the current status of trial NCT03797326?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 611 participants. The study started on 2019-02-12. Estimated completion is 2024-10-28.
What interventions are being tested in trial NCT03797326?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT03797326?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03797326's enrollment target sits among peer trials
611 53rd of 2000 higher than 1,948 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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