Ifinatamab deruxtecan for advanced esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional trial gives ifinatamab deruxtecan (I-DXd), an antibody-drug conjugate, to people with unresectable locally advanced or metastatic esophageal squamous cell carcinoma who have progressed after 1–2 prior systemic therapies. The study enrolls patients with measurable disease and adequate organ function and tracks tumor response rates, specifically how many participants experience tumor shrinkage or disappearance. The protocol is conducted under a master screening framework (KEYMAKER-U06) and includes planned management for adverse events, including rescue medication as needed. Sites are at major cancer centers in Japan and the trial is sponsored by Merck with collaboration from Daiichi Sankyo.

Why it matters

Who can join: the full rules

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

Where it's running

• UPMC Hillman Cancer Center ( Site 3904)
  Pittsburgh, Pennsylvania, United States Recruiting
• Liga Norte Riograndense Contra o Cancer ( Site 3301)
  Natal, Rio Grande do Norte, Brazil Recruiting
• Hospital Nossa Senhora Da Conceicao ( Site 3300)
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Fundación Arturo López Pérez ( Site 3400)
  Santiago, Region M. de Santiago, Chile Recruiting
• Bradfordhill ( Site 3401)
  Santiago, Region M. de Santiago, Chile Recruiting
• Anhui Provincial Hospital ( Site 2506)
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.