Clinical Study

A Pilot Study Of Pembrolizumab And Lenvatinib Combination Therapy In Patients With Previously Treated Advanced Gastroesophageal Adenocarcinoma

Posted Date: Oct 19, 2021

  • Investigator: Davendra Sohal
  • Specialties: Cancer, Head and Neck Cancer, Oncology
  • Type of Study: Drug

The purpose of this study is to study the effect of pembrolizumab and lenvatinib in treating patients with gastroesophageal adenocarcinoma that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may kill more tumor cells. The study will consist of 1 experimental arm where patients will receive pembrolizumab IV over 30 minutes on day 1 and lenvatinib PO QD, and treatment repeats every 42 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Efficacy will be determined by the overall response rate.


Has A Documented, Previously Treated, Advanced (Unresectable And/Or Metastatic) Gastroesophageal Adenocarcinoma That Is Incurable And For Which Prior First-Line Or Later-Line Standard Of Care (Soc) Treatments Have Failed. Has Measurable Disease Based On Recist 1.1 As Assessed By The Investigator. Has A Performance Status Of 0 Or 1 On The Eastern Cooperative Oncology Group (Ecog) Performance Scale Within 5 Days Of Starting Study Treatment. Bp =< 150/90 Mm Hg At Screening And No Change In Antihypertensive Medications Within 1 Week Of Cycle 1 Day 1. Anc >= 1,500/Ul. Platelets >= 100,000/Ul. Hemoglobin >= 9 G/Dl Or >= 5.6 Mmol/L Without Transfusion Or Epo Dependency. Serum Creatinine =< 1.5 X Upper Limit Of Normal. Total Bilirubin < 1.5 X Uln. Albumin >= 2.5 Mg/Dl. No Patient That Is Currently Currently Participating In Or Has Participated In A Study Of An Investigational Agent Or Used An Investigational Device Within 4 Weeks Prior To The First Dose Of Study Treatment. No Patient That Has A Diagnosis Of Immunodeficiency Or Is Receiving Systemic Steroid Therapy (In Dosing Exceeding 10 Mg Daily Of Prednisone Equivalent) Or Any Other Form Of Immunosuppressive Therapy Within 7 Days Prior To The First Dose Of Trial Treatment. No Patient That Has Had Major Surgery Within 3 Weeks Prior To First Dose Of Study Interventions. No Preexisting >= Grade 3 Gastrointestinal Or Non-Gastrointestinal Fistula. No Urine Protein >= 1 G/24 Hours. No Patient That Has Significant Gastrointestinal Malabsorption, Gastrointestinal Anastomosis, Or Any Other Condition That Might Affect The Absorption Of Lenvatinib. No Patient That Has Clinically Significant Hemoptysis Or Tumor Bleeding Within 2 Weeks Prior To The First Dose Of Study Drug. No Significant Cardiovascular Impairment Within 12 Months Of The First Dose Of Study Drug. No Prolongation Of Corrected Qt (Qtc) Interval To > 480 Ms. No Known Additional Progressing Malignancy. No Known Active Central Nervous System (Cns) Metastases And/Or Carcinomatous Meningitis. No Active Autoimmune Disease That Has Required Systemic Treatment In The Past 2 Years.


Adenocarcinoma, Cancer, Head And Neck

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