Trials / Completed
CompletedNCT03524326
Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma
A Phase I/Ib Study of Lenvatinib and Cetuximab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a phase I study, which tests the safety of different doses of lenvatinib in combination with cetuximab, to see which dose is the safest in people. This study will help find out if lenvatinib and cetuximab is a safe and useful combination for treating patients with HNSCC and cSCC.
Conditions
- Head and Neck Squamous Cell Carcinoma
- Cutaneous Squamous Cell Carcinoma
- Head and Neck Cancer
- Head and Neck Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib Pill | 24 mg oral daily |
| DRUG | Lenvatinib Pill | 20 mg oral daily |
| DRUG | Lenvatinib Pill | 14 mg oral daily |
| DRUG | Cetuximab | 400mg/m2 IV, then 500mg/m2 IV weekly |
| DRUG | Lenvatinib Pill | 10 mg oral daily |
| DRUG | Lenvatinib Pill | 4 mg oral daily |
Timeline
- Start date
- 2018-04-30
- Primary completion
- 2022-10-13
- Completion
- 2022-10-13
- First posted
- 2018-05-14
- Last updated
- 2025-05-13
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03524326. Inclusion in this directory is not an endorsement.