What this study is
The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). 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 goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.
What's being tested
- I-DXd
Intervention · BIOLOGICAL
IV Infusion
- Rescue Medication
Intervention · DRUG
Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid, administered per approved product label
Study details
- Official title
- A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Oesophageal Squamous Cell Carcinoma
- Enrolling
- 60 people
- Starts
- 2026-03-27
- Est. completion
- 2028-06-12
- Design
- Open-label, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)
- Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC
- Has measurable disease
- If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy
- Has adequate organ function
You can't join if
- Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
- Has clinically significant corneal disease
- Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event
- If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has uncontrolled or significant cardiovascular disease
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has 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 other than those permitted.
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (32)
32 openUPMC Hillman Cancer Center ( Site 3904)
Pittsburgh, Pennsylvania, United States
- Study Coordinator · Contact816-898-9413
Recruiting
31 sites outside the US
Liga Norte Riograndense Contra o Cancer ( Site 3301)
Natal, Rio Grande do Norte, Brazil
- Study Coordinator · Contact+55 84 4009-5595
RecruitingHospital Nossa Senhora Da Conceicao ( Site 3300)
Porto Alegre, Rio Grande do Sul, Brazil
- Study Coordinator · Contact+555135160954
RecruitingFundación Arturo López Pérez ( Site 3400)
Santiago, Region M. de Santiago, Chile
- Study Coordinator · Contact+56224457398
RecruitingBradfordhill ( Site 3401)
Santiago, Region M. de Santiago, Chile
- Study Coordinator · Contact+56229490970
Recruiting- Recruiting
Beijing Cancer Hospital ( Site 2500)
Beijing, Beijing Municipality, China
- Study Coordinator · Contact+8601088140650
RecruitingThe First Affiliated hospital of Xiamen University ( Site 2504)
Xiamen, Fujian, China
- Study Coordinator · Contact+865922139767
Recruiting- Recruiting
- Recruiting
- Recruiting
Zhejiang Cancer Hospital ( Site 2511)
Hangzhou, Zhejiang, China
- Study Coordinator · Contact+8660571-88122261
RecruitingMasarykuv onkologicky ustav ( Site 4000)
Brno, Brno-mesto, Czechia
- Study Coordinator · Contact+420543131111
Recruiting- Recruiting
Kanagawa Cancer Center ( Site 2701)
Yokohama, Kanagawa, Japan
- Study Coordinator · Contact+81-45-520-2222
RecruitingNational Cancer Center Hospital ( Site 2700)
Chūō, Tokyo, Japan
- Study Coordinator · Contact+81-3-3542-2511
RecruitingOslo universitetssykehus, Radiumhospitalet ( Site 3501)
Oslo, Norway
- Study Coordinator · Contact+4722934000
RecruitingNational Cancer Center ( Site 2902)
Goyang-si, Kyonggi-do, South Korea
- Study Coordinator · Contact+8219200440
Recruiting- Recruiting
- Recruiting
Kantonsspital Graubünden-Medizin ( Site 3700)
Chur, Kanton Graubünden, Switzerland
- Study Coordinator · Contact+41 81 256 61 11
RecruitingHopitaux Universitaires de Geneve HUG ( Site 3701)
Geneva, Switzerland
- Study Coordinator · Contact+41 22 372 29 01
RecruitingChang Gung Memorial Hospital at Kaohsiung ( Site 3003)
Kaohsiung City, Taiwan
- Study Coordinator · Contact+88677317123
RecruitingChina Medical University Hospital ( Site 3007)
Taichung, Taiwan
- Study Coordinator · Contact886-4-22052121
RecruitingNational Cheng Kung University Hospital ( Site 3001)
Tainan, Taiwan
- Study Coordinator · Contact+886-6-235-3535
RecruitingNational Taiwan University Hospital ( Site 3000)
Taipei, Taiwan
- Study Coordinator · Contact+886-2-23123456
RecruitingNational Taiwan University Cancer Center (NTUCC) ( Site 3010)
Taipei, Taiwan
- Study Coordinator · Contact+886223220322
RecruitingTaipei Veterans General Hospital ( Site 3005)
Taipei, Taiwan
- Study Coordinator · Contact886-2-28717270
RecruitingChang Gung Memorial Hospital - Linkou Branch ( Site 3006)
Taoyuan, Taiwan
- Study Coordinator · Contact+88633281200
RecruitingFaculty of Medicine Siriraj Hospital ( Site 3102)
Bangkoknoi, Bangkok, Thailand
- Study Coordinator · Contact+6624194488
RecruitingChulalongkorn University ( Site 3104)
Pathumwan, Bangkok, Thailand
- Study Coordinator · Contact02-256-4533
RecruitingSongklanagarind Hospital ( Site 3101)
Hat Yai, Changwat Songkhla, Thailand
- Study Coordinator · Contact+6674451469
Recruiting
Study team
Sponsor
Merck Sharp & Dohme LLC
Study ID 3475-06F
Study director
Medical Director
Merck Sharp & Dohme LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.