470
Participants
Start Date
July 11, 2018
Primary Completion Date
September 26, 2025
Study Completion Date
September 26, 2025
MK-4830
MK-4830 will be administered intravenously (IV) Q3W. In Part C, MK-4830 will be administered after completion of pembrolizumab infusion. Dose escalation will proceed based on emerging safety and tolerability data of MK-4830 as monotherapy (Part A and B) and as combination therapy with pembrolizumab (Part C). For each dose level, an assessment will be made of the safety and tolerability data in order to define the next dose level to be tested.
Pembrolizumab
Pembrolizumab will be administered at 200 mg IV Q3W.
Carboplatin
Carboplatin will be administered IV Q3W.
Pemetrexed
Pemetrexed will be administered IV Q3W.
Lenvatinib
Lenvatinib will be administered orally once daily.
Paclitaxel
Paclitaxel will be administered IV QW on Days 1, 8, and 15 of each 21-day cycle until disease progression or prohibitive toxicity (Arm J) and on Days 1, 8, and 15 Q4W until disease progression or prohibitive toxicity (Arm K).
Cisplatin
Cisplatin will be administered IV Q3W.
MK-4830A
MK-4830A, a coformulation of MK-4830 800 mg + pembrolizumab 200 mg, will be administered IV Q3W.
Liverpool Hospital-Medical Oncology ( Site 0250), Liverpool
Wits Clinical Research ( Site 0213), Johannesburg
The Oncology Centre ( Site 0212), Durban
Princess Alexandra Hospital ( Site 0253), Brisbane
Cancercare Rondebosch Oncology ( Site 0210), Cape Town
Laura and Isaac Perlmutter Cancer Center ( Site 0008), New York
Centro Integral Oncologico Clara Campal START Madrid ( Site 0102), Madrid
Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 00, Columbus
Henry Ford Health System ( Site 0002), Detroit
European Interbalkan Medical Center ( Site 0111), Thessaloniki
Centre Oscar Lambret ( Site 2002), Lille
Washington University ( Site 0003), St Louis
Hôpital Européen Georges Pompidou ( Site 2003), Paris
South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001), San Antonio
Utah Cancer Specialists ( Site 0011), Salt Lake City
Centre Hospitalier Universitaire de Poitiers ( Site 2000), Poitiers
University of California at San Francisco ( Site 0004), San Francisco
Seattle Cancer Care Alliance ( Site 0010), Seattle
The First Hospital of Jilin University ( Site 0803), Changchun
Shanghai Chest Hospital-Oncology department ( Site 0801), Shanghai
West China Hospital of Sichuan University ( Site 0804), Chengdu
National Cancer Center Hospital East ( Site 0400), Kashiwa
Rambam Health Care Campus-Oncology Division ( Site 0042), Haifa
Rabin Medical Center ( Site 0043), Petah Tikva
Chaim Sheba Medical Center. ( Site 0044), Ramat Gan
Sourasky Medical Center ( Site 0041), Tel Aviv
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005), Hackensack
Juravinski Cancer Centre ( Site 0034), Hamilton
The Ottawa Hospital ( Site 0031), Ottawa
Princess Margaret Cancer Centre ( Site 0033), Toronto
University General Hospital of Heraklion ( Site 0110), Heraklion
Euromedica General Clinic of Thessaloniki-Oncology Unit ( Site 0112), Thessaloniki
Japanese Foundation for Cancer Research ( Site 0401), Tokyo
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warsaw
Uniwersyteckie Centrum Kliniczne ( Site 0151), Gdansk
Severance Hospital Yonsei University Health System ( Site 0300), Seoul
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0101), L'Hospitalet de Llobregat
Merck Sharp & Dohme LLC
INDUSTRY