Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
Completed · Phase 3
Conditions studied: Metastatic Esophageal Squamous Cell Carcinoma
In brief
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma. The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). As of Amendment 09, Study MK-7902-014 will begin close out activities. Any participant who discontinues study intervention for any reason will be discontinued from the study without further follow-up. Second Course and treatment beyond disease progression will no longer be offered. No safety concerns contributed to the termination of this study.
Key facts
- Study ID
- NCT04949256
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 863
- Starts
- 2021-07-28
- Expected to finish
- 2026-05-20
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
- Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
- Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab, 30 days after the last dose of lenvatinib, or 180 days after the last dose of chemotherapy, whichever occurs last, and agrees not to donate eggs during this period
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization
- Has adequate organ function
You may not qualify if…
- Has had previous therapy for locally advanced unresectable or metastatic esophageal cancer
- Has locally advanced esophageal carcinoma
- Has metastatic adenocarcinoma of the esophagus
- Has direct invasion into adjacent organs such as the aorta or trachea
- Has radiographic evidence of encasement of a major blood vessel, or of intratumoral cavitation
- Has perforation risks or significant gastrointestinal (GI) bleeding
- Has had clinically significant hemoptysis within 3 weeks prior to the first dose of study drug or tumor bleeding within 2 weeks prior to the first dose of study intervention
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
- Has GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent
- Has had major surgery, open biopsy, or significant traumatic injury within 3 weeks prior to first dose of study interventions
- Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
- Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, or has a history of organ transplant, including allogeneic stem cell transplant
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed
- Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
- Has poorly controlled diarrhea
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Has peripheral neuropathy ≥Grade 2
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B or know active Hepatitis C virus infection
- Has a weight loss of >20% within the last 3 months
Where it is running
- MedStar Washington Hospital Center ( Site 0186) — Washington D.C., District of Columbia, United States
- James Graham Brown Cancer Center ( Site 0117) — Louisville, Kentucky, United States
- Norton Cancer Institute ( Site 0116) — Louisville, Kentucky, United States
- Johns Hopkins Bayview Medical Center ( Site 0152) — Baltimore, Maryland, United States
- UMASS Memorial Medical Center ( Site 0120) — Worcester, Massachusetts, United States
- Capital Health Medical Center - Hopewell ( Site 0189) — Pennington, New Jersey, United States
- Hematology-Oncology Associates of CNY ( Site 0173) — East Syracuse, New York, United States
- Memorial Sloan Kettering Cancer Center ( Site 0132) — New York, New York, United States
- Weill Cornell Medical College ( Site 0133) — New York, New York, United States
- St. Luke's University Health Network ( Site 0185) — Bethlehem, Pennsylvania, United States
- AHN Allegheny General Hospital ( Site 0164) — Pittsburgh, Pennsylvania, United States
- Medical University of South Carolina-Hollings Cancer Center ( Site 0177) — Charleston, South Carolina, United States
- VCU Health Adult Outpatient Pavillion ( Site 0160) — Richmond, Virginia, United States
- Seattle Cancer Care Alliance ( Site 0145) — Seattle, Washington, United States
- Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203) — Berazategui, Buenos Aires, Argentina
- IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202) — CABA, Buenos Aires, Argentina
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205) — Mar del Plata, Buenos Aires, Argentina
- Fundacion Estudios Clinicos-Oncology ( Site 0215) — Rosario, Santa Fe Province, Argentina
- Sanatorio Parque ( Site 0206) — Rosario, Santa Fe Province, Argentina
- Hospital Provincial del Centenario ( Site 0217) — Rosario, Santa Fe Province, Argentina
- Fundacion Favaloro ( Site 0201) — Buenos Aires, Argentina
- Fundación Respirar ( Site 0216) — Buenos Aires, Argentina
- Hospital Italiano de Córdoba ( Site 0218) — Córdoba, Argentina
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221) — La Rioja, Argentina
- City of Hope ( Site 0102) — Duarte, California, United States
Full record on ClinicalTrials.gov
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