Back to resultsA Study of Combination Therapies With Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer (MK-3475-06A)
Primary Purpose
Esophageal Squamous Cell Carcinoma (ESCC)
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Coformulation favezelimab/pembrolizumab
MK-4830
Lenvatinib
Irinotecan
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma (ESCC) focused on measuring Esophageal cancer, Programmed Cell Death 1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL-1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL-2, PD-L2)
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC
- Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy.
- Has an evaluable baseline tumor sample (newly obtained or archival) for analysis
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
Exclusion Criteria:
- Direct invasion into adjacent organs such as the aorta or trachea
- Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
- Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in past 2 years
- History of human immunodeficiency virus (HIV) infection
- History of Hepatitis B or known active Hepatitis C virus infection
- History of allogenic tissue/solid organ transplant
- Clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Participants with known gastrointestinal (GI) malabsorption or any other condition that may affect the absorption of lenvatinib
- Has risk for significant GI bleeding, such as:
- Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization
- Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization
Sites / Locations
- Liga Norte Riograndense Contra o Câncer ( Site 2303)Recruiting
- Hospital Nossa Senhora da Conceição ( Site 2301)Recruiting
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)Recruiting
- FALP-UIDO ( Site 2400)Recruiting
- Clínica las Condes ( Site 2403)Recruiting
- Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1104)Recruiting
- Hopital Claude Huriez - CHU de Lille ( Site 1100)Recruiting
- Pitie Salpetriere University Hospital ( Site 1102)Recruiting
- Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 2801)Recruiting
- Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 2804)Recruiting
- Ospedale San Raffaele-Oncologia Medica ( Site 1206)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1200)Recruiting
- Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (Recruiting
- Aichi Cancer Center Hospital ( Site 1702)Recruiting
- National Cancer Center Hospital East ( Site 1701)Recruiting
- Saitama Prefectural Cancer Center ( Site 1703)Recruiting
- Shizuoka Cancer Center ( Site 1704)Recruiting
- National Cancer Center Hospital ( Site 1700)Recruiting
- Asan Medical Center-Department of Oncology ( Site 1901)Recruiting
- Samsung Medical Center-Division of Hematology/Oncology ( Site 1900)Recruiting
- Oslo universitetssykehus, Radiumhospitalet ( Site 2501)Recruiting
- National University Hospital ( Site 1800)Recruiting
- Hôpitaux Universitaires de Genève (HUG) ( Site 2702)Recruiting
- Kantonsspital Graubünden-Medizin ( Site 2700)Recruiting
- Chang Gung Memorial Hospital at Kaohsiung ( Site 2003)Recruiting
- China Medical University Hospital ( Site 2007)Recruiting
- Taichung Veterans General Hospital-Radiation Oncology ( Site 2008)Recruiting
- National Cheng Kung University Hospital ( Site 2001)Recruiting
- National Taiwan University Hospital ( Site 2000)Recruiting
- Taipei Veterans General Hospital ( Site 2005)Recruiting
- Chang Gung Medical Foundation-Linkou Branch ( Site 2006)Recruiting
- Chulalongkorn University ( Site 2104)Recruiting
- Faculty of Medicine Siriraj Hospital ( Site 2102)Recruiting
- Songklanagarind hospital ( Site 2105)Recruiting
- I.E.U. Medical Point Hastanesi-Oncology ( Site 1406)Recruiting
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 1402)Recruiting
- Ankara City Hospital-Medical Oncology ( Site 1405)Recruiting
- Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1410)Recruiting
- Atatürk Üniversitesi-onkoloji ( Site 1416)Recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1403)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Pembrolizumab plus chemotherapy
Coformulation Favezelimab/Pembrolizumab plus Chemotherapy
Pembrolizumab plus MK-4380 plus Chemotherapy
Pembrolizumab plus MK-4380 plus lenvatinib
Arm Description
Participants will receive pembrolizumab intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Participants will receive coformulation of favezelimab/pembrolizumab administered intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Participants will receive pembrolizumab intravenously plus MK-4380 plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Participants will receive pembrolizumab intravenously plus MK-4380 plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Outcomes
Primary Outcome Measures
Number of Participants Experiencing a Dose-limiting Toxicity (DLT) During Safety Lead-in Phase
A DLT is defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.
Number of Participants Experiencing an Adverse Event (AE) During Safety Lead-in Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Secondary Outcome Measures
Progression-Free Survival (PFS)
PFS is defined as the time from allocation to the first documented progressive disease (PD) as assessed by RECIST 1.1 or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Duration of Response (DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Overall Survival (OS)
OS is defined as the time from the date of allocation to death from any cause.
Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Full Information
NCT ID
NCT05342636
First Posted
April 19, 2022
Last Updated
October 11, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05342636
Brief Title
A Study of Combination Therapies With Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer (MK-3475-06A)
Official Title
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
November 8, 2024 (Anticipated)
Study Completion Date
September 21, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previously exposed to programmed cell death 1 protein (PD-1)/ programmed cell death ligand 1 (PD-L1) based treatment.
Detailed Description
The master protocol is MK-3475-U06.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma (ESCC)
Keywords
Esophageal cancer, Programmed Cell Death 1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL-1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL-2, PD-L2)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab plus chemotherapy
Arm Type
Experimental
Arm Description
Participants will receive pembrolizumab intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Arm Title
Coformulation Favezelimab/Pembrolizumab plus Chemotherapy
Arm Type
Experimental
Arm Description
Participants will receive coformulation of favezelimab/pembrolizumab administered intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Arm Title
Pembrolizumab plus MK-4380 plus Chemotherapy
Arm Type
Experimental
Arm Description
Participants will receive pembrolizumab intravenously plus MK-4380 plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Arm Title
Pembrolizumab plus MK-4380 plus lenvatinib
Arm Type
Experimental
Arm Description
Participants will receive pembrolizumab intravenously plus MK-4380 plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
200 mg administered via intravenous (IV) infusion every 3 weeks (Q3W)
Intervention Type
Drug
Intervention Name(s)
Coformulation favezelimab/pembrolizumab
Other Intervention Name(s)
MK-4280A
Intervention Description
800 mg favezelimab + 200 mg pembrolizumab administered via IV infusion on day 1 and then Q3W
Intervention Type
Drug
Intervention Name(s)
MK-4830
Other Intervention Name(s)
anti-immunoglobulin-like transcript 4 (ILT4)
Intervention Description
800 mg administered via IV infusion Q3W
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
MK-7902, LENVIMA®
Intervention Description
20 mg administered via oral capsules each day
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
180 mg/m^2 administered via IV infusion on day 1 of every 14-day cycle.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
80-100 mg/m^2 administered via IV infusion on Days 1, 8 and 15 of every 28 day cycle
Primary Outcome Measure Information:
Title
Number of Participants Experiencing a Dose-limiting Toxicity (DLT) During Safety Lead-in Phase
Description
A DLT is defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.
Time Frame
Up to approximately 3 weeks
Title
Number of Participants Experiencing an Adverse Event (AE) During Safety Lead-in Phase
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 3 Weeks
Title
Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 3 weeks
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time Frame
Up to approximately 119 weeks
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from allocation to the first documented progressive disease (PD) as assessed by RECIST 1.1 or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Time Frame
Up to approximately 216 weeks
Title
Duration of Response (DOR)
Description
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time Frame
Up to approximately 216 weeks
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of allocation to death from any cause.
Time Frame
Up to approximately 216 weeks
Title
Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 216 weeks
Title
Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 104 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC
Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy.
Has an evaluable baseline tumor sample (newly obtained or archival) for analysis
Has adequately controlled blood pressure (BP) with or without antihypertensive medications
Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
Exclusion Criteria:
Direct invasion into adjacent organs such as the aorta or trachea
Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active autoimmune disease that has required systemic treatment in past 2 years
History of human immunodeficiency virus (HIV) infection
History of Hepatitis B or known active Hepatitis C virus infection
History of allogenic tissue/solid organ transplant
Clinically significant cardiovascular disease within 12 months from first dose of study intervention
Participants with known gastrointestinal (GI) malabsorption or any other condition that may affect the absorption of lenvatinib
Has risk for significant GI bleeding, such as:
Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization
Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Liga Norte Riograndense Contra o Câncer ( Site 2303)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59062-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
55 84 991191032
Facility Name
Hospital Nossa Senhora da Conceição ( Site 2301)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5551993590437
Facility Name
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5511993103312
Facility Name
FALP-UIDO ( Site 2400)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56224457254
Facility Name
Clínica las Condes ( Site 2403)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7591047
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56995993148
Facility Name
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1104)
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33298223428
Facility Name
Hopital Claude Huriez - CHU de Lille ( Site 1100)
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33640652949
Facility Name
Pitie Salpetriere University Hospital ( Site 1102)
City
Paris
State/Province
Orne
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33142161041
Facility Name
Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 2801)
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
496976014187
Facility Name
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 2804)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4930450657306
Facility Name
Ospedale San Raffaele-Oncologia Medica ( Site 1206)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390226437624
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1200)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390223903835
Facility Name
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390257490439
Facility Name
Aichi Cancer Center Hospital ( Site 1702)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-52-762-6111
Facility Name
National Cancer Center Hospital East ( Site 1701)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-4-7133-1111
Facility Name
Saitama Prefectural Cancer Center ( Site 1703)
City
Ina-machi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-48-722-1111
Facility Name
Shizuoka Cancer Center ( Site 1704)
City
Nagaizumi-cho,Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-55-989-5222
Facility Name
National Cancer Center Hospital ( Site 1700)
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3542-2511
Facility Name
Asan Medical Center-Department of Oncology ( Site 1901)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82230107179
Facility Name
Samsung Medical Center-Division of Hematology/Oncology ( Site 1900)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82234106518
Facility Name
Oslo universitetssykehus, Radiumhospitalet ( Site 2501)
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4723026600
Facility Name
National University Hospital ( Site 1800)
City
Singapore
State/Province
South West
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+65 6779 5555
Facility Name
Hôpitaux Universitaires de Genève (HUG) ( Site 2702)
City
Genève
State/Province
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
41223729861
Facility Name
Kantonsspital Graubünden-Medizin ( Site 2700)
City
Chur
State/Province
Grisons
ZIP/Postal Code
7000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
41812566884
Facility Name
Chang Gung Memorial Hospital at Kaohsiung ( Site 2003)
City
Kaohsiung Niao Sung Dist
State/Province
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886975056058
Facility Name
China Medical University Hospital ( Site 2007)
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886975680932
Facility Name
Taichung Veterans General Hospital-Radiation Oncology ( Site 2008)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8864235925255613
Facility Name
National Cheng Kung University Hospital ( Site 2001)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886623535354620
Facility Name
National Taiwan University Hospital ( Site 2000)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886223123456
Facility Name
Taipei Veterans General Hospital ( Site 2005)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8862287121212573
Facility Name
Chang Gung Medical Foundation-Linkou Branch ( Site 2006)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88633281200
Facility Name
Chulalongkorn University ( Site 2104)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+ุุ6622564533
Facility Name
Faculty of Medicine Siriraj Hospital ( Site 2102)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6624194488
Facility Name
Songklanagarind hospital ( Site 2105)
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6674451469
Facility Name
I.E.U. Medical Point Hastanesi-Oncology ( Site 1406)
City
Izmir, Karsiyaka
State/Province
Izmir
ZIP/Postal Code
009035575
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905052642353
Facility Name
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1402)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
903123052910
Facility Name
Ankara City Hospital-Medical Oncology ( Site 1405)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905555306271
Facility Name
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1410)
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+90 5421572862
Facility Name
Atatürk Üniversitesi-onkoloji ( Site 1416)
City
Erzurum
ZIP/Postal Code
25070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905072864555
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1403)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905063509061
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
A Study of Combination Therapies With Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer (MK-3475-06A)
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