Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma
NCT03524326 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-05-13
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
- DRUG
-
Lenvatinib Pill
24 mg oral daily
- DRUG
-
Lenvatinib Pill
20 mg oral daily
- DRUG
-
Lenvatinib Pill
14 mg oral daily
- DRUG
-
400mg/m2 IV, then 500mg/m2 IV weekly
- DRUG
-
Lenvatinib Pill
10 mg oral daily
- DRUG
-
Lenvatinib Pill
4 mg oral daily
Sponsors & Collaborators
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Lara Dunn, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-30
- Primary Completion
- 2022-10-13
- Completion
- 2022-10-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of the Combination of Cetuximab and Methotrexate in Recurrent or Metastatic Cancer of the Head and Neck
NCT02054442 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer
NCT01884623 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
NCT07063212 ·Status: RECRUITING ·Phase: PHASE2
-
Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
NCT03370276 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)
NCT00343083 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Cetuximab With or Without OSI-906 in Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT01427205 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer
NCT05249426 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study of Sorafenib/Cetuximab in Head and Neck Cancer
NCT00815295 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma
NCT00968435 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)
NCT04199104 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT01602315 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)
NCT04428151 ·Status: COMPLETED ·Phase: PHASE2
-
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC
NCT05057247 ·Status: COMPLETED ·Phase: PHASE2
-
A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
NCT01080066 ·Status: COMPLETED
-
Safety, Tolerability, and Efficacy Study of CLL442 in Patients With Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
NCT03333694 ·Status: TERMINATED ·Phase: PHASE1
-
Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
NCT03082534 ·Status: COMPLETED ·Phase: PHASE2
-
Cetuximab and Lenalidomide in Head and Neck
NCT01133665 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC
NCT06855212 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Pilot Study of Imatinib Cetuximab Combo for H & N Cancer
NCT05816785 ·Status: ACTIVE_NOT_RECRUITING ·Phase: EARLY_PHASE1
-
Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer
NCT02177838 ·Status: TERMINATED ·Phase: NA
-
A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer
NCT04722523 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC
NCT00882583 ·Status: TERMINATED ·Phase: PHASE1
-
Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT02643550 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Sunitinib, Cetuximab, and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
NCT00906360 ·Status: TERMINATED ·Phase: PHASE1
-
Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma
NCT03422536 ·Status: COMPLETED ·Phase: PHASE2