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NCT06780111PHASE1, PHASE2Recruiting

Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)

Merck Sharp & Dohme LLC

Start Date

7/30/2025

Completion Date

1/4/2032

Summary

Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts. Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. Researchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.

Detailed Description

The master protocol is MK-3475-U06.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting. * Has measurable disease per RECIST 1.1 as assessed by the local site. investigator or designee/radiology assessment and verified by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. * Has had AEs due to previous anticancer therapies that have recovered to ≤Grade 1 or baseline. Endocrine-related AEs that are adequately treated with hormone replacement are elegible. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART). * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Has adequate organ function. Exclusion Criteria The main exclusion criteria include but are not limited to the following: * Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer. * Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula. * Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention. * Has clinically significant corneal disease, history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention. * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Has inadequate cardiac function assessed as by a corrected QT interval by Fredericia (QTcF) value ≥470 msec. * Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. * Has peripheral neuropathy ≥ Grade 2. * Has diagnosis of immunodeficiency or is receiving chronic 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 study intervention. * Has 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 active autoimmune disease that has required systemic treatment in the past 2 years. * Has had a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), has a current diagnosis of ILD, or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out. * Has active infection requiring systemic therapy. * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder.

Interventions

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

I-DXd

DRUG

Leucovorin

DRUG

Levoleucovorin

DRUG

5-Fluorouracil (5-FU)

DRUG

Oxaliplatin

BIOLOGICAL

Sacituzumab tirumotecan

DRUG

Rescue Medication

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Conditions

Esophageal Squamous Cell Carcinoma

Locations

UPMC Hillman Cancer Center ( Site 1904)

Pittsburgh, Pennsylvania 15232

United States

Liga Norte Riograndense Contra o Cancer ( Site 1301)

Natal, Rio Grande do Norte 59062-000

Brazil

Hospital Nossa Senhora da Conceicao ( Site 1300)

Porto Alegre, Rio Grande do Sul 91010-004

Brazil

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1302)

São Paulo, 01246-000

Brazil

Clínica Puerto Montt ( Site 1406)

Port Montt, Los Lagos Region 5500243

Chile

FALP ( Site 1400)

Santiago, Region M. de Santiago 7500921

Chile

Centro de Oncología de Precisión ( Site 1402)

Santiago, Region M. de Santiago 7560908

Chile

Clínica UC San Carlos de Apoquindo ( Site 1403)

Santiago, Region M. de Santiago 7620002

Chile

Bradfordhill ( Site 1401)

Santiago, Region M. de Santiago 8420383

Chile

Bradford Hill Norte ( Site 1405)

Antofagasta, 1263521

Chile

The Second Affiliated Hospital of Anhui Medical University ( Site 9511)

Hefei, Anhui 230601

China

Beijing Cancer Hospital ( Site 9500)

Beijing, Beijing Municipality 130021

China

The First Affiliated Hospital of Xiamen University ( Site 9503)

Xiamen, Fujian 361003

China

Henan Cancer Hospital ( Site 9509)

Zhengzhou, Henan 450008

China

Xuzhou Central Hospital ( Site 9512)

Xuzhou, Jiangsu 221000

China

The First Affiliated Hospital of Nanchang University ( Site 9505)

Nanchang, Jiangxi 330006

China

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)

Brno, Brno-mesto 656 53

Czechia

C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)

Brest, Finistere 29609

France

CHU Lille - Institut Coeur Poumon ( Site 9100)

Lille, Nord 59037

France

Pitie Salpetriere University Hospital ( Site 9102)

Paris, 75013

France

Universitaetsklinikum Duesseldorf ( Site 1808)

Düsseldorf, North Rhine-Westphalia 40225

Germany

Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)

Dresden, Saxony 01307

Germany

Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1807)

Hamburg, 20249

Germany

Ospedale San Raffaele-Oncologia Medica ( Site 9201)

Milan, Lombardy 20132

Italy

Istituto Oncologico Veneto IRCCS ( Site 9202)

Padova, Veneto 35128

Italy

Aichi Cancer Center ( Site 9702)

Nagoya, Aichi-ken 464-8681

Japan

National Cancer Center Hospital East ( Site 9701)

Kashiwa, Chiba 277-8577

Japan

National Cancer Center Hospital ( Site 9700)

Chūō, Tokyo 104-0045

Japan

Oslo Universitetssykehus Radiumhospitalet ( Site 1501)

Oslo, 0379

Norway

National University Hospital ( Site 9800)

Singapore, Central Singapore 119074

Singapore

National Cancer Center ( Site 9902)

Goyang-si, Kyonggi-do 10408

South Korea

Asan Medical Center ( Site 9901)

Seoul, 05505

South Korea

Samsung Medical Center ( Site 9900)

Seoul, 06351

South Korea

Kantonsspital Graubuenden ( Site 1700)

Chur, Kanton Graubünden 7000

Switzerland

Hopitaux Universitaires de Geneve HUG. ( Site 1701)

Geneva, 1211

Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)

Kaoshiung, Kaohsiung 807

Taiwan

Kaohsiung Chang Gung Memorial Hospital ( Site 1003)

Kaohsiung City, 83301

Taiwan

China Medical University Hospital ( Site 1007)

Taichung, 40707

Taiwan

National Cheng Kung University Hospital ( Site 1001)

Tainan, 704

Taiwan

National Taiwan University Hospital ( Site 1000)

Taipei, 100225

Taiwan

Taipei Veterans General Hospital ( Site 1005)

Taipei, 11217

Taiwan

Chang Gung Memorial Hospital - Linkou Branch ( Site 1006)

Taoyuan, 33305

Taiwan

Ramathibodi Hospital ( Site 1103)

Ratchathewi, Bangkok 10400

Thailand

Songklanagarind hospital ( Site 1101)

Hat Yai, Changwat Songkhla 90110

Thailand