LEAP-010
14 Dec 2020
Trial Summary
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.
Acronym:
LEAP-010
ACTRN/NCT /ethics:
NCT04199104
Scientific title:
A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).
Sponsor / Cooperative group:
Merck Sharp & Dohme Corp.
Trial & Patient Characteristics
| Cancer Type | Head and Neck |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | All |
| Tumour Stream | - |
| Cancer Stage | Metastatic or Widespread, Locally Recurrent or Locally Advanced |
| Anticipated Start Date | 2020-02-05 |
| Anticipated End Date | 2024-04-24 |
Participating Hospitals
| Hospital | Royal Adelaide Hospital |
|---|---|
| Clinical Trial Coordinator | Anne Milton |
| anne.milton@sa.gov.au | |
| Phone | 08 7074 2342 |
| Principal Investigator | Dr Anne Taylor |
| Recruitment Status | Recruiting |