Clinical Trials List
2025-02-07 - 2032-12-31
Phase I/II
Recruiting7
ICD-10C15.3
Malignant neoplasm of upper third of esophagus
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9150.0
Malignant neoplasm of cervical esophagus
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/06/15
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- TA-CHEN HUANG 無
- Chia-Chi Lin 無
- 郭弘揚 無
- 莊建淮 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien-An Liu 無
- Tien-Hua Chen 無
- Yi-Ping Hung 無
- 陳宥任 無
- Yun-Cheng Hsieh 無
- 姜乃榕 無
- 翁敬堯 無
- Chueh-Chuan Yen 無
- Hung-Yuan Yu 無
- 唐振育 無
- 黃宣恩 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Yu Lien Division of Hematology & Oncology
- 王幸婷 Division of Hematology & Oncology
- Chi-Ching Chen
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Hsun Chen Digestive System Department
- Wang Yao-Kuang
- Li-Tzong Chen Digestive System Department
- 王閔宏 Division of Hematology & Oncology
- Jeng-Shiun Du Division of Hematology & Oncology
- Tsung-Jang Yeh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉奕廷 Division of Hematology & Oncology
- Chih-Chieh Yen Digestive System Department
- Wei-Lun Chang
- Shang-Yin Wu
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Injection
Injection
Injection
Injection
Active Ingredient
1013005400
1008400200
1012001600
CALCIUM FOLINATE (EQ TO FOLINIC ACID)
Dosage Form
270
270
270
270
Dosage
25 mg/ vial
50mg/mL
5mg/ml
Endpoints
Accidental adverse events (AEs).
Objective response: Confirmed complete response (CR) or partial response (PR).
Inclution Criteria
The main inclusion criteria include but are not limited to the following:
Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting.
Has measurable disease per RECIST 1.1 as assessed by the local site. investigator or designee/radiology assessment and verified by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
Has AEs due to previous anticancer therapies of ≤Grade 1 or baseline (except alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone replacement are acceptable.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Has adequate organ function.
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer.
Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula.
Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
Has clinically significant corneal disease, history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.
Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Has inadequate cardiac function assessed as: - corrected QT interval by Fredericia (QTcF) value >470 msec.
Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
Has peripheral neuropathy ≥ Grade 2.
Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Has had (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, and/or suspected interstitial lung disease (ILD)/pneumonitis that cannot be ruled out by imaging at Screening.
Has active infection requiring systemic therapy.
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
228 participants
