Back to resultsA Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)
Primary Purpose
Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
favezelimab/pembrolizumab
bendamustine
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Eligibility Criteria
Inclusion Criteria:
- Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
- Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
- Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
- Submits an archival (<5 years) or newly obtained tumor tissue sample which has not been previously irradiated.
Exclusion Criteria:
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
- History of central nervous system (CNS) metastases or active CNS involvement.
- Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic treatment.
- History of hemophagocytic lymphohisticytosis.
- Has an active seizure disorder that is not well controlled.
- Has clinically significant (ie, active) cardiovascular disease.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
- Has not adequately recovered from major surgical procedure.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- History of human immunodeficiency virus (HIV).
- Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.
Sites / Locations
- University of Kentucky Chandler Medical Center ( Site 2201)Recruiting
- Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206)Recruiting
- Cleveland Clinic-Taussig Cancer Center ( Site 2203)Recruiting
- AHN West Penn Hospital ( Site 2213)Recruiting
- UPMC Hillman Cancer Center ( Site 2205)Recruiting
- Fred Hutchinson Cancer Center ( Site 2212)Recruiting
- Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0002)Recruiting
- Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site GodiRecruiting
- UZ Leuven-Hematology ( Site 0101)Recruiting
- Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0202)Recruiting
- Hospital Paulistano-Americas Oncologia ( Site 0207)Recruiting
- Anhui Provincial Cancer Hospital ( Site 0501)Recruiting
- Peking University Third Hospital-Hematology ( Site 0519)Recruiting
- The First Affiliated hospital of Xiamen University ( Site 0512)Recruiting
- Sun Yat-sen University Cancer Center-Internal medicine ( Site 0500)Recruiting
- Henan Cancer Hospital ( Site 0515)Recruiting
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0509)Recruiting
- The First Hospital of Jilin University-Hematology ( Site 0516)Recruiting
- Fudan University Shanghai Cancer Center ( Site 0520)Recruiting
- West China Hospital of Sichuan University-Head and Neck Oncology ( Site 0502)Recruiting
- Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 0506)Recruiting
- Zhejiang Cancer Hospital ( Site 0510)Recruiting
- Ningbo First Hospital ( Site 0518)Recruiting
- Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0706)Recruiting
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0704)Recruiting
- CENTRE LEON BERARD-Medical oncology ( Site 0703)Recruiting
- Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0801)Recruiting
- Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit (Recruiting
- Universitätsklinikum Leipzig ( Site 0803)Recruiting
- Rambam Health Care Campus ( Site 1004)Recruiting
- Hadassah Medical Center-Hemato-Oncology ( Site 1000)Recruiting
- Rabin Medical Center-Hemato-Oncology ( Site 1001)Recruiting
- Sheba Medical Center-Hemato Oncology ( Site 1005)Recruiting
- Sourasky Medical Center ( Site 1002)Recruiting
- Seoul National University Hospital ( Site 1701)Recruiting
- Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1702)Recruiting
- Samsung Medical Center ( Site 1700)Recruiting
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Hematologii, Nowotworów Krwi iRecruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( SiteRecruiting
- Hospital Universitario Marqués de Valdecilla ( Site 1805)Recruiting
- Hospital General Universitario de Alicante ( Site 1806)Recruiting
- Hospital Universitari Vall d'Hebron ( Site 1803)Recruiting
- Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1801)Recruiting
- Skånes Universitetssjukhus Lund ( Site 1901)Recruiting
- Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1900)Recruiting
- Mega Medipol-Hematology ( Site 2005)Recruiting
- Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000)Recruiting
- Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006)Recruiting
- Kocaeli Üniversitesi-Hematology ( Site 2009)Recruiting
- Derriford Hospital ( Site 2107)Recruiting
- St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2105)Recruiting
- GenesisCare - Oxford ( Site 2104)Recruiting
- Leicester Royal Infirmary ( Site 2100)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Favezelimab/Pembrolizumab
Chemotherapy (Bendamustine or Gemcitabine)
Arm Description
Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.
Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by BICR or death due to any cause, whichever occurs first.
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by BICR
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by BICR.
Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR
For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Number of Participants Who Experienced At Least One Adverse Event (AE)
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. The number of participants who experience an AE will be presented.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
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. The number of participants who discontinue study treatment due to an AE will be presented.
Full Information
NCT ID
NCT05508867
First Posted
August 18, 2022
Last Updated
October 19, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05508867
Brief Title
A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)
Official Title
A Phase 3 Randomized Clinical Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
June 16, 2031 (Anticipated)
Study Completion Date
June 16, 2031 (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
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Favezelimab/Pembrolizumab
Arm Type
Experimental
Arm Description
Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.
Arm Title
Chemotherapy (Bendamustine or Gemcitabine)
Arm Type
Active Comparator
Arm Description
Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.
Intervention Type
Biological
Intervention Name(s)
favezelimab/pembrolizumab
Other Intervention Name(s)
MK-4820A
Intervention Description
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
Intervention Type
Drug
Intervention Name(s)
bendamustine
Other Intervention Name(s)
BENDEKA®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
GEMZAR®
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR)
Description
PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by BICR or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 43 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 105 months
Title
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by BICR
Description
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by BICR.
Time Frame
Up to approximately 25 months
Title
Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR
Description
For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 43 months
Title
Number of Participants Who Experienced At Least One Adverse Event (AE)
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. The number of participants who experience an AE will be presented.
Time Frame
Up to approximately 27 months
Title
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
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. The number of participants who discontinue study treatment due to an AE will be presented.
Time Frame
Up to approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
Submits an archival (<5 years) or newly obtained tumor tissue sample which has not been previously irradiated.
Exclusion Criteria:
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
History of central nervous system (CNS) metastases or active CNS involvement.
Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic treatment.
History of hemophagocytic lymphohisticytosis.
Has an active seizure disorder that is not well controlled.
Has clinically significant (ie, active) cardiovascular disease.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
Has not adequately recovered from major surgical procedure.
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
History of human immunodeficiency virus (HIV).
Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.
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
University of Kentucky Chandler Medical Center ( Site 2201)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
832-443-9325
Facility Name
Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
410-502-0882
Facility Name
Cleveland Clinic-Taussig Cancer Center ( Site 2203)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
216-444-0857
Facility Name
AHN West Penn Hospital ( Site 2213)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
585-978-1478
Facility Name
UPMC Hillman Cancer Center ( Site 2205)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
415-572-9678
Facility Name
Fred Hutchinson Cancer Center ( Site 2212)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-388-5811
Facility Name
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0002)
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61395944044
Facility Name
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3281423831
Facility Name
UZ Leuven-Hematology ( Site 0101)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+32 16 34 25 14
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0202)
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
551733216637
Facility Name
Hospital Paulistano-Americas Oncologia ( Site 0207)
City
Sao Paulo
ZIP/Postal Code
01321-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5511992926463
Facility Name
Anhui Provincial Cancer Hospital ( Site 0501)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8618900518383
Facility Name
Peking University Third Hospital-Hematology ( Site 0519)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
86 13661112910
Facility Name
The First Affiliated hospital of Xiamen University ( Site 0512)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8618750918842
Facility Name
Sun Yat-sen University Cancer Center-Internal medicine ( Site 0500)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13808885154
Facility Name
Henan Cancer Hospital ( Site 0515)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13838176375
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0509)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 02785726114
Facility Name
The First Hospital of Jilin University-Hematology ( Site 0516)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 15843073208
Facility Name
Fudan University Shanghai Cancer Center ( Site 0520)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13651603660
Facility Name
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 0502)
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
028-85422114
Facility Name
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 0506)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
022-23340123-6416
Facility Name
Zhejiang Cancer Hospital ( Site 0510)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13857182590
Facility Name
Ningbo First Hospital ( Site 0518)
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
15968985233
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0706)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33531156191
Facility Name
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0704)
City
Limoges
State/Province
Haute-Vienne
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33555058606
Facility Name
CENTRE LEON BERARD-Medical oncology ( Site 0703)
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33 4 78 78 26 84
Facility Name
Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0801)
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4922147898888
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit (
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
493514582311
Facility Name
Universitätsklinikum Leipzig ( Site 0803)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
493419713841
Facility Name
Rambam Health Care Campus ( Site 1004)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97246828114
Facility Name
Hadassah Medical Center-Hemato-Oncology ( Site 1000)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97226776687
Facility Name
Rabin Medical Center-Hemato-Oncology ( Site 1001)
City
Petah-Tikva
ZIP/Postal Code
4910021
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97239378078
Facility Name
Sheba Medical Center-Hemato Oncology ( Site 1005)
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97235305343
Facility Name
Sourasky Medical Center ( Site 1002)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97236973782
Facility Name
Seoul National University Hospital ( Site 1701)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-2-2072-3559
Facility Name
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1702)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-2-2228-1972
Facility Name
Samsung Medical Center ( Site 1700)
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
+82-2-3410-6548
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Hematologii, Nowotworów Krwi i
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48793779909
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
22 546 22 23
Facility Name
Hospital Universitario Marqués de Valdecilla ( Site 1805)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
942204078
Facility Name
Hospital General Universitario de Alicante ( Site 1806)
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34611194484
Facility Name
Hospital Universitari Vall d'Hebron ( Site 1803)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34 932746000
Facility Name
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1801)
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
923291100 ext 55974
Facility Name
Skånes Universitetssjukhus Lund ( Site 1901)
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
004646177858
Facility Name
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1900)
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
46186110213
Facility Name
Mega Medipol-Hematology ( Site 2005)
City
Stanbul
State/Province
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905437870708
Facility Name
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
05055025050
Facility Name
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
05337203142
Facility Name
Kocaeli Üniversitesi-Hematology ( Site 2009)
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905052591227
Facility Name
Derriford Hospital ( Site 2107)
City
Plymouth
State/Province
Devon
ZIP/Postal Code
Pl6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
441752431043
Facility Name
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2105)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02078828264
Facility Name
GenesisCare - Oxford ( Site 2104)
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX4 6LB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 1865 224808
Facility Name
Leicester Royal Infirmary ( Site 2100)
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 808 178 8337
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
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=4280A-008&kw=4280A-008
Description
Plain Language Summary
Learn more about this trial
A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)
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