A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)

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

Overview

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.

Detailed description

The master screening protocol is MK-3475-U06 (KEYMAKER-U06)

Interventions

• Biological I-DXd
  IV Infusion
• Drug Rescue Medication
  Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid, administered per approved product label

Primary outcome measures

• Objective Response Rate (ORR) [Time frame: Up to approximately 14 months]

Secondary outcome measures (5)

• Duration of Response (DOR) [Time frame: Up to approximately 18 months]
• Progression-Free Survival (PFS) [Time frame: Up to approximately 18 months]
• Overall Survival (OS) [Time frame: Up to approximately 26 months]
• Number of Participants Who Experience an Adverse Events (AEs) [Time frame: Up to approximately 18 months]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 18 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Taiwan · 7 centers

• Chang Gung Memorial Hospital at Kaohsiung ( Site 3003) — Kaohsiung City
• China Medical University Hospital ( Site 3007) — Taichung
• National Cheng Kung University Hospital ( Site 3001) — Tainan
• National Taiwan University Hospital ( Site 3000) — Taipei
• National Taiwan University Cancer Center (NTUCC) ( Site 3010) — Taipei
• Taipei Veterans General Hospital ( Site 3005) — Taipei
• Chang Gung Memorial Hospital - Linkou Branch ( Site 3006) — Taoyuan

Japan · 3 centers

• Aichi Cancer Center ( Site 2702) — Nagoya
• Kanagawa Cancer Center ( Site 2701) — Yokohama
• National Cancer Center Hospital ( Site 2700) — Chūō

South Korea · 3 centers

• National Cancer Center ( Site 2902) — Goyang-si
• Asan Medical Center ( Site 2901) — Seoul
• Samsung Medical Center ( Site 2900) — Seoul

China · 2 centers

• Beijing Cancer Hospital ( Site 2500) — Beijing
• Jinan Central Hospital ( Site 2507) — Jinan

Switzerland · 2 centers

• Kantonsspital Graubünden-Medizin ( Site 3700) — Chur
• Hopitaux Universitaires de Geneve HUG ( Site 3701) — Geneva

Thailand · 2 centers

• Faculty of Medicine Siriraj Hospital ( Site 3102) — Bangkoknoi
• Songklanagarind Hospital ( Site 3101) — Hat Yai

United States · 1 center

• UPMC Hillman Cancer Center ( Site 3904) — Pittsburgh

Brazil · 1 center

• Liga Norte Riograndense Contra o Cancer ( Site 3301) — Natal

Czechia · 1 center

• Masarykuv onkologicky ustav ( Site 4000) — Brno

Norway · 1 center

• Oslo universitetssykehus, Radiumhospitalet ( Site 3501) — Oslo

Identifiers

NCT: NCT07405151 · 3475-06F · 2026-525213-31-00 · U1111-1329-6558 · MK-3475-06F · jRCT2041250179

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗