A Clinical Study of Ifinatamab Deruxtecan in People with Advanced Esophageal Cancer
Descrizione riassuntiva dello studio
This study is open to patients with esophageal cancer (esophageal squamous cell carcinoma, ESCC) that is • non-operable, • advanced or has spread to other parts of the body, • has not responded to a prior treatment that must have included a platinum-based therapy and an anti-PD-1/PD-L1 inhibitor. This study follows a so-called "platform" design. This means that over time, when a drug from a previous study appears promising, new treatments can be added and compared with a control treatment (the current standard therapy), or existing study drugs can be removed if they prove ineffective. Before you participate in the study, the study doctor will discuss with you what treatments you may receive. The investigational drugs used in this study have already been tested for safety in early (Phase 1) studies. This study scientifically investigates how well the drugs work against ESCC that is non-operable and advanced or has spread and has already been treated with a combination of chemotherapy and immunotherapy. This study will also examine whether the drugs can help patients live longer. The safety of the study drugs will also be continuously monitored. Approximately 60 people are expected to participate in this study worldwide. About 2 patients will participate in Switzerland. The study will last approximately 1.5 years.
(BASEC)
Intervento studiato
The study doctor will explain the study to you and ask if you agree to participate (informed consent). Then, it will be checked whether you meet all the requirements for participation in the study, and your medical history will be collected. If all requirements are met, you will be enrolled in the study.
The study doctor will inform you about which medications you may receive and how you will receive them, for example, through an intravenous line. He or she will also inform you how often you need to visit the study center.
You will receive the study drug as long as you tolerate it, your cancer does not progress, and your overall health allows it. During and after treatment, your health will be regularly monitored using imaging tests for any progression of the cancer.
This is an open-label study. This means that both you and the study doctor know what you are receiving.
During study visits, various measures and examinations may be conducted. These include, among others: questioning about your well-being and current medications, administration of the study drug, imaging tests (bone scan, CT and/or MRI), heart examinations (radionuclide ventriculography [MUGA] or echocardiography [ECHO] as well as a 12-lead ECG), collection of blood and urine samples, measurement of vital signs (pulse, blood pressure, etc.), and examination of your eyes.
(BASEC)
Malattie studiate
Esophageal cancer, also known as esophageal carcinoma, begins in the esophagus but can spread to other parts of the body. The esophagus is the tube that carries food and drinks from the mouth to the stomach. There are two main types of esophageal cancer: esophageal adenocarcinoma and esophageal squamous cell carcinoma (ESCC). This study will only include patients with ESCC. The first-line treatment for advanced/metastatic ESCC is usually a combination of chemotherapies that includes a platinum-based drug. Recent scientific findings suggest that the additional administration of immunotherapy (anti-PD-1 inhibitor) may help extend patients' lives. If the first-line treatment is not effective, the second-line treatment typically consists of a chemotherapy drug. However, despite these ESCC therapies, patient survival remains limited. Therefore, better options for second-line therapy and later treatments are needed.
(BASEC)
• Presence of confirmed inoperable (not completely removable by surgery), locally advanced or metastatic (spread to other body parts) ESCC that worsened after one or two different therapies. One of these therapies must have included a platinum-based chemotherapy as well as an anti-PD-1/PD-L1 inhibitor. • Presence of a measurable disease assessed by imaging, evaluated by the study center and a central committee. • Availability of a tumor tissue sample taken after disease progression under previous treatment. (BASEC)
Criteri di esclusione
• Presence of adenocarcinoma or adenosquamous carcinoma. • Occurrence of a stroke, transient ischemic attack, or other arterial thromboembolic event in the past 6 months, or presence of uncontrolled or significant cardiovascular disease. • Current or past pneumonia or suspicion of pneumonia, or presence of a serious lung problem. (BASEC)
Luogo dello studio
Chur, Ginevra
(BASEC)
Sponsor
MSD Merck Sharp & Dohme AG, Switzerland Merck Sharp & Dohme LLC, USA
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Klaudia Georgi
+41 79 512 34 39
gctoch@cluttermsd.comMSD Merck Sharp & Dohme AG Global Clinical Trial Operations Werftestrasse 4 6005 Luzern
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
27.03.2026
(BASEC)
ID di studio ICTRP
NCT07405151 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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 (BASEC)
Titolo accademico
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 (ICTRP)
Titolo pubblico
A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F) (ICTRP)
Malattie studiate
Oesophageal Squamous Cell Carcinoma (ICTRP)
Intervento studiato
Biological: I-DXdDrug: Rescue Medication (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 a history of (noninfectious) pneumonitis/interstitial lung disease irrespective
of requiring steroids or has any current pneumonitis/interstitial lung disease or
has suspected pneumonitis/interstitial lung disease
- 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, Sjgren's syndrome,
sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen (ICTRP)
non disponibile
Endpoint primari e secondari
Objective Response Rate (ORR) (ICTRP)
Duration of Response (DOR);Progression-Free Survival (PFS);Overall Survival (OS);Number of Participants Who Experience an Adverse Events (AEs);Number of Participants Who Discontinue Study Treatment Due to an AE (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Daiichi Sankyo (ICTRP)
Contatti aggiuntivi
Medical DirectorToll Free Number, Trialsites@msd.com, 1-888-577-8839, Merck Sharp & Dohme LLC (ICTRP)
ID secondari
2026-525213-31-00, U1111-1329-6558, MK-3475-06F, jRCT2041250179, 3475-06F (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT07405151 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile