Mk-7902-009-A Phase 2, Randomized, Open-Label Three-Arm Clinical Study To Evaluate The Safety And Efficacy Of Lenvatinib (E7080/Mk-7902) In Combination With Pembrolizumab (Mk-3475) Versus Standard Of Care Chemotherapy And Lenvatinib Monotherapy In Partici
Posted Date: May 5, 2021
- Investigator: Christopher Lemmon
- Specialties: Cancer, Head and Neck Cancer, Oncology
- Type of Study: Drug
The primary purpose of this study is to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary outcome measure is objective responsive rate.
Criteria:
Histologically Confirmed Recurrent (Not Amenable To Curative Treatment With Local And/Or Systemic Therapies) Or Metastatic (Disseminated) Hnscc Of The Oral Cavity, Oropharynx, Hypopharynx, And/Or Larynx That Is Considered Incurable By Local Therapies, Ecog Of 0 Or 1, Adequately Controlled Blood Pressure (Bp) With Or Without Antihypertensive Medications, Adequate Organ Function. No Life Expectancy Of Less Than 3 Months, No Other Malignancy Within 3 Years, No History Of Organ Transplantation, No Chemotherapy Or Radiation Within 2 Weeks, No Past Or Active Medical Condition That May Impact The Patient's Ability To Adhere To Study Treatment
Keywords:
Head And Neck Cancer, Hnscc
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com