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NCT03776136 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)
A Phase 2 study of Advanced Melanoma, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT03776136: Completed Phase 2 study of Advanced Melanoma, sponsored by Merck Sharp & Dohme.
NCT03776136 is a Phase 2 study of Advanced Melanoma that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 103 participants, below the 167-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03776136, a Phase 2 study of Advanced Melanoma, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of combination therapy of lenvatinib (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy and approximately 2 years or more lenvatinib therapy in adult participants with unresectable or advanced melanoma who have been exposed to anti-programmed cell death ligand 1 (PD-1/L1) agents approved for unresectable or metastatic melanoma. No statistical hypothesis will be tested in this study.
Primary Outcome
ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ).
Conditions Studied
Interventions
- BIOLOGICAL pembrolizumab
- DRUG lenvatinib
Study Locations (20)
Other
- Lismore Base Hospital ( Site 0153) - Lismore
- Hospital Clinic i Provincial Barcelona ( Site 0001) - Barcelona
- Hospital General Universitario Gregorio Maranon ( Site 0003) - Madrid
- Hospital Universitario Virgen de la Macarena ( Site 0004) - Seville
- Hospital General Universitario de Valencia ( Site 0002) - Valencia
- Sahlgrenska Universitetssjukhuset ( Site 0052) - Gothenburg
Ontario
- Sunnybrook Research Institute ( Site 0654) - Toronto
- Princess Margaret Cancer Centre ( Site 0655) - Toronto
Quebec
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652) - Montreal
- McGill University Health Centre ( Site 0651) - Montreal
Arizona
- Ironwood Cancer & Research Centers ( Site 0312) - Chandler
California
- John Wayne Cancer Institute ( Site 0301) - Santa Monica
Illinois
- Advocate Medical Group-Park Ridge ( Site 0313) - Park Ridge
Nebraska
- Southeast Nebraska Cancer Center ( Site 0316) - Lincoln
Texas
- Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0317) - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2019-01-30 |
| Est. Completion | 2023-10-11 |
| Phase | Phase 2 |
What the finished NCT03776136 record still lists
NCT03776136 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 167-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Advanced Melanoma appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT03776136 names 20 study sites across 13 states, led by Other, Ontario, Quebec.
Frequently Asked Questions
What is clinical trial NCT03776136 about?
NCT03776136 is a clinical study titled "Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)". This study will evaluate the safety and efficacy of combination therapy of lenvatinib (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy and approximately 2 years or more lenvatinib therapy in adult participants with unresectable or advanced melanoma who have ...
What is the current status of trial NCT03776136?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2019-01-30. Estimated completion is 2023-10-11.
What conditions does trial NCT03776136 study?
This clinical trial studies the following conditions: Advanced Melanoma.
What interventions are being tested in trial NCT03776136?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), lenvatinib (DRUG).
Who is sponsoring clinical trial NCT03776136?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03776136 being conducted?
This trial has 20 study locations across Arizona, California, Illinois, Nebraska, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03776136's enrollment target sits among peer trials
103 8th of 21 higher than 14 of 21 other Advanced Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Melanoma 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.
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