Clinical trial NCT05508867: 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 2 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: 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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.


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.

Primary outcomes:
measure: Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by investigator
timeFrame: Up to approximately 39 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 39 months
measure: Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by investigator
timeFrame: Up to approximately 39 months
measure: Duration of Response (DOR) per Lugano Response Criteria as Assessed by investigator
timeFrame: Up to approximately 39 months
measure: Number of Participants Who Experienced At Least One Adverse Event (AE)
timeFrame: Up to approximately 25 months
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center - North Campus ( Site 2216)
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 2208)
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center ( Site 2200)
state: Florida
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center ( Site 2201)
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 2210)
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206)
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan ( Site 2215)
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan ( Site 2222)
state: Michigan
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 2217)
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute ( Site 2220)
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 2214)
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic-Taussig Cancer Center ( Site 2203)
state: Ohio
city: Pittsburgh
country: United States
facility: AHN West Penn Hospital ( Site 2213)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center ( Site 2205)
state: Pennsylvania
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center ( Site 2212)
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Aleman-oncohematologic diseases ( Site 2302)
city: Mendoza
country: Argentina
facility: Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 2301)
city: Townsville
country: Australia
facility: The Townsville Hospital ( Site 0006)
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital ( Site 0005)
state: South Australia
city: St Albans
country: Australia
facility: Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0002)
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital-Haematology ( Site 0004)
state: Western Australia
city: Leuven
country: Belgium
facility: UZ Leuven-Hematology ( Site 0101)
state: Vlaams-Brabant
city: Namur
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0202)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano-Americas Oncologia ( Site 0207)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0313)
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0310)
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0309)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0314)
state: Quebec
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0400)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica Inmunocel ( Site 0407)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital ( Site 0501)
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital ( Site 0514)
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital-Hematology ( Site 0519)
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University ( Site 0512)
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center ( Site 0500)
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 0515)
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0509)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University ( Site 0513)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0503)
state: Hunan
city: Changchun
country: China
facility: The First Hospital of Jilin University-Hematology ( Site 0516)
state: Jilin
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 0520)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University-Head and Neck Oncology ( Site 0502)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 0506)
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0510)
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital ( Site 0518)
state: Zhejiang
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0901)
state: Brno-mesto
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0902)
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0903)
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 0707)
state: Bretagne
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0706)
state: Haute-Garonne
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0704)
state: Haute-Vienne
city: Saint-Cloud
country: France
facility: Institut Curie - site Saint-Cloud ( Site 0708)
state: Hauts-de-Seine
city: Lyon
country: France
facility: CENTRE LEON BERARD-Medical oncology ( Site 0703)
state: Rhone
city: Créteil
country: France
facility: HENRI MONDOR HOSPITAL ( Site 0702)
state: Seine-et-Marne
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart - Katharinenhospital ( Site 0804)
state: Baden-Wurttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm-Department of Internal Medicine III ( Site 0805)
state: Baden-Wurttemberg
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 0807)
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0801)
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 0806)
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit (
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig ( Site 0803)
state: Sachsen
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 1004)
city: Haifa
country: Israel
facility: Carmel Hospital ( Site 1007)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hemato-Oncology ( Site 1000)
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center-Hemato-Oncology ( Site 1001)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-Hemato Oncology ( Site 1005)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1002)
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital-Internal Medicine ( Site 1704)
state: Pusan-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1701)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1702)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Department of Oncology ( Site 1703)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1700)
city: Ciudad de México
country: Mexico
facility: Centro de Infusion Superare ( Site 2503)
state: Distrito Federal
city: Puebla
country: Mexico
facility: Unidad Médica Onco-hematológica ( Site 2507)
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Hematologii, Nowotworów Krwi i
state: Dolnoslaskie
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1406)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1402)
state: Pomorskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S
state: Swietokrzyskie
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla ( Site 1805)
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron ( Site 1803)
state: Cataluna
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1812)
state: La Coruna
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria-Oncology ( Site 1807)
state: Las Palmas
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante ( Site 1806)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 1810)
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria ( Site 1808)
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1801)
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus Lund ( Site 1901)
state: Skane Lan
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1900)
state: Uppsala Lan
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale Bellinzona e Valli-IOSI ( Site 1600)
state: Ticino
city: Stanbul
country: Turkey
facility: Mega Medipol-Hematology ( Site 2005)
state: Istanbul
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006)
city: Antalya
country: Turkey
facility: Antalya Egitim ve Arastırma Hastanesi ( Site 2011)
city: İzmir
country: Turkey
facility: Ege Universitesi Hastanesi ( Site 2001)
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi-Hematology ( Site 2009)
city: Plymouth
country: United Kingdom
facility: Derriford Hospital ( Site 2107)
state: Devon
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre ( Site 2110)
state: Glasgow City
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2105)
state: London, City Of
city: Oxford
country: United Kingdom
facility: GenesisCare - Oxford ( Site 2104)
state: Oxfordshire
city: Leeds
country: United Kingdom
facility: St James's University Hospital ( Site 2109)
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary ( Site 2100)
city: Liverpool
country: United Kingdom
facility: Clatterbridge Cancer Centre - Liverpool-Heamatology ( Site 2108)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: