Actively Recruiting
A Phase 2 Open-Label Study of Ifinatamab Deruxtecan in Participants With Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-05
60
Participants Needed
17
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating if ifinatamab deruxtecan (I-DXd), an antibody-drug conjugate, can treat esophageal squamous cell carcinoma (ESCC) that is advanced and cannot be removed by surgery. The study focuses on participants whose cancer has progressed after one or two previous treatments. The goal is to see how many participants have their cancer shrink or disappear with this treatment. Participants will receive I-DXd through an intravenous infusion every three weeks. Treatment continues until the cancer worsens or other reasons require stopping. Rescue medications like 5-HT3 receptor antagonists, NK-1 receptor antagonists, and corticosteroids may be given as needed according to approved guidelines. This is part of a larger master screening protocol called KEYMAKER-U06. During the study, participants will be regularly monitored for how their cancer responds, including measuring tumor size and tracking how long the response lasts. Safety is also closely watched by recording any side effects and treatment discontinuations related to adverse events. The main response rate will be assessed for up to about 14 months, with additional outcomes like survival tracked for up to 26 months. The total participation period depends on individual treatment response and safety.
CONDITIONS
Brief Title
A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal squamous cell carcinoma
- Disease progression after 1 or 2 prior systemic therapies for unresectable locally advanced or metastatic ESCC
- Measurable disease
- Well-controlled HIV on antiretroviral therapy if infected with HIV
- Adequate organ function
You will not qualify if you...
- Histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
- Clinically significant corneal disease
- Cerebrovascular accident, transient ischemic attack, or arterial thromboembolic event within 6 months before screening
- History of Kaposi's sarcoma and/or Multicentric Castleman's Disease if infected with HIV
- Uncontrolled or significant cardiovascular disease
- Known additional malignancy progressing or requiring treatment within past 3 years
- Known active central nervous system metastases and/or carcinomatous meningitis
- Any history of interstitial lung disease/pneumonitis except radiation pneumonitis not requiring steroids
- Active infection requiring systemic therapy other than permitted
- Clinically severe pulmonary compromise from intercurrent illnesses or underlying pulmonary disorders, prior pneumonectomy, or supplemental oxygen requirement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until progressive disease or discontinuation
Participants receive I-DXd by IV infusion every 3 weeks until disease progression or discontinuation criteria are met.
Visits every 3 weeks for IV infusion
Trial Site Locations
Total: 17 locations
1
Masarykuv onkologicky ustav ( Site 4000)
Brno, Brno-mesto, Czechia, 565 53
Actively Recruiting
2
Aichi Cancer Center ( Site 2702)
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
3
Kanagawa Cancer Center ( Site 2701)
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
4
National Cancer Center Hospital ( Site 2700)
Chūō, Tokyo, Japan, 104-0045
Actively Recruiting
5
Oslo universitetssykehus, Radiumhospitalet ( Site 3501)
Oslo, Norway, 0379
Actively Recruiting
6
National Cancer Center ( Site 2902)
Goyang-si, Kyonggi-do, South Korea, 10408
Actively Recruiting
7
Asan Medical Center ( Site 2901)
Seoul, South Korea, 05505
Actively Recruiting
8
Samsung Medical Center ( Site 2900)
Seoul, South Korea, 06351
Actively Recruiting
9
Kantonsspital Graubünden-Medizin ( Site 3700)
Chur, Kanton Graubünden, Switzerland, 7000
Actively Recruiting
10
Hopitaux Universitaires de Geneve HUG ( Site 3701)
Geneva, Switzerland, 1211
Actively Recruiting
11
Chang Gung Memorial Hospital at Kaohsiung ( Site 3003)
Kaohsiung City, Taiwan, 83301
Actively Recruiting
12
China Medical University Hospital ( Site 3007)
Taichung, Taiwan, 40447
Actively Recruiting
13
National Cheng Kung University Hospital ( Site 3001)
Tainan, Taiwan, 704
Actively Recruiting
14
National Taiwan University Hospital ( Site 3000)
Taipei, Taiwan, 10002
Actively Recruiting
15
National Taiwan University Cancer Center (NTUCC) ( Site 3010)
Taipei, Taiwan, 106
Actively Recruiting
16
Taipei Veterans General Hospital ( Site 3005)
Taipei, Taiwan, 11217
Actively Recruiting
17
Chang Gung Memorial Hospital - Linkou Branch ( Site 3006)
Taoyuan, Taiwan, 33305
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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