Rescue Medication: Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase — Up to approximately 28 days Percentage of participants experiencing toxicities that are possibly, probably, or definitely related to study intervention; that meet pre-defined severity criteria; and result in a change in the given dose.
Percentage of Participants who Experience an Adverse Event (AE) — Up to approximately 77 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE will be reported.
Objective Response Rate (ORR) — Up to approximately 77 months ORR is defined as a confirmed complete response (CR: the disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Trial sites (48)
Facility
City
Region
Status
UPMC Hillman Cancer Center ( Site 1904)
Pittsburgh
Pennsylvania
Recruiting
Liga Norte Riograndense Contra o Cancer ( Site 1301)
Natal
Rio Grande do Norte
Recruiting
Hospital Nossa Senhora da Conceicao ( Site 1300)
Porto Alegre
Rio Grande do Sul
Recruiting
IBCC - Instituto Brasileiro de Controle do Cancer ( Site 1303)
São Paulo
São Paulo
Recruiting
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1302)
São Paulo
Brazil
Recruiting
Clínica Puerto Montt ( Site 1406)
Port Montt
Los Lagos Region
Recruiting
FALP ( Site 1400)
Santiago
Region M. de Santiago
Recruiting
Centro de Oncología de Precisión ( Site 1402)
Santiago
Region M. de Santiago
Recruiting
Clínica UC San Carlos de Apoquindo ( Site 1403)
Santiago
Region M. de Santiago
Recruiting
Bradfordhill ( Site 1401)
Santiago
Region M. de Santiago
Recruiting
Bradford Hill Norte ( Site 1405)
Antofagasta
Chile
Recruiting
The Second Affiliated Hospital of Anhui Medical University ( Site 9511)
Hefei
Anhui
Recruiting
Beijing Cancer Hospital ( Site 9500)
Beijing
Beijing Municipality
Recruiting
The First Affiliated Hospital of Xiamen University ( Site 9503)
Xiamen
Fujian
Recruiting
Henan Cancer Hospital ( Site 9509)
Zhengzhou
Henan
Recruiting
Xuzhou Central Hospital ( Site 9512)
Xuzhou
Jiangsu
Recruiting
The First Affiliated Hospital of Nanchang University ( Site 9505)
Nanchang
Jiangxi
Recruiting
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)
Brno
Brno-mesto
Recruiting
C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)
Brest
Finistere
Recruiting
CHU Lille - Institut Coeur Poumon ( Site 9100)
Lille
Nord
Recruiting
Pitie Salpetriere University Hospital ( Site 9102)
Paris
France
Recruiting
HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 1807)
Erdgeschoss
Free and Hanseatic City of Hamburg
Recruiting
Universitaetsklinikum Duesseldorf ( Site 1808)
Düsseldorf
North Rhine-Westphalia
Recruiting
Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)
Dresden
Saxony
Recruiting
Ospedale San Raffaele-Oncologia Medica ( Site 9201)
Milan
Lombardy
Recruiting
Istituto Oncologico Veneto IRCCS ( Site 9202)
Padova
Veneto
Recruiting
Aichi Cancer Center ( Site 9702)
Nagoya
Aichi-ken
Recruiting
National Cancer Center Hospital East ( Site 9701)
Kashiwa
Chiba
Recruiting
National Cancer Center Hospital ( Site 9700)
Chūō
Tokyo
Recruiting
Oslo Universitetssykehus Radiumhospitalet ( Site 1501)
Oslo
Norway
Recruiting
National University Hospital ( Site 9800)
Singapore
Central Singapore
Recruiting
National Cancer Center ( Site 9902)
Goyang-si
Kyonggi-do
Recruiting
Asan Medical Center ( Site 9901)
Seoul
South Korea
Recruiting
Samsung Medical Center ( Site 9900)
Seoul
South Korea
Recruiting
Kantonsspital Graubuenden ( Site 1700)
Chur
Kanton Graubünden
Recruiting
Hopitaux Universitaires de Geneve HUG. ( Site 1701)
Geneva
Switzerland
Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)
Kaoshiung
Kaohsiung
Recruiting
Kaohsiung Chang Gung Memorial Hospital ( Site 1003)
Kaohsiung City
Taiwan
Recruiting
China Medical University Hospital ( Site 1007)
Taichung
Taiwan
Recruiting
National Cheng Kung University Hospital ( Site 1001)
Tainan
Taiwan
Recruiting
+ 8 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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