Phase
Condition
Lymphoma, B-cell
Lymphoma
Treatment
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab Coformulated With Hyaluronidase
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) or primarymediastinal B-cell lymphoma (PMBCL)
Radiographically measurable cHL or PMBCL disease assessed by investigator as perLugano classification
Have a life expectancy of >3 months
Human immunodeficiency virus (HIV)-infected participants must have well controlledHIV on antiretroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks,and have undetectable HBV viral load before enrollment
Participants with history of hepatitis C virus (HCV) infection are eligible if theyhave completed curative antiviral therapy at least 4 weeks before enrollment and HCVviral load is undetectable at screening
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1assessed within 7 days before or on the day of the first dose of study intervention
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has clinically significant (i.e., active) cardiovascular disease
Has pericardial effusion or clinically significant pleural effusion
Has known additional malignancy that is progressing or has required active treatmentwithin the past 2 years
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any otherform of immunosuppressive therapy within 7 days prior to the first dose of studyintervention
Received prior monoclonal antibody within 4 weeks prior to first dose of studyintervention or has not recovered (i.e., ≤Grade 1 or at baseline) from adverseevents (AEs) due to agents administered more than 4 weeks earlier
Received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1),anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell deathligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory orcoinhibitory T-cell receptor
Received prior systemic anticancer therapy including investigational agents within 4weeks before the first dose of study intervention
Received prior radiotherapy within 2 weeks of start of study intervention, or hasradiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before first dose of studyintervention
Is receiving systemic antineoplastic chemotherapy, immunotherapy, or biologicaltherapy not specified in this protocol
Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis
Active autoimmune disease that has required systemic treatment in the past 2 years
History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease
Active infection requiring systemic therapy except certain protocol-specifiedtherapies
Concurrent active hepatitis B and hepatitis C virus infection
Has undergone solid organ transplant at any time, or prior allogeneic hematopoieticstem cell transplant (SCT) within the last 5 years
Study Design
Connect with a study center
Westmead Hospital ( Site 0901)
Westmead, New South Wales 2145
AustraliaSite Not Available
Westmead Hospital ( Site 0901)
Westmead 2143973, New South Wales 2155400 2145
AustraliaSite Not Available
Biocenter ( Site 0203)
Concepcion, Biobio 4070196
ChileSite Not Available
Biocenter ( Site 0203)
Concepcion., Biobio 4070196
ChileSite Not Available
IC La Serena Research ( Site 0204)
La Serena., Coquimbo 1700000
ChileSite Not Available
IC La Serena Research ( Site 0204)
La Serena 3884373, Coquimbo Region 3893623 1720430
ChileSite Not Available
Bradfordhill-Clinical Area ( Site 0202)
Santiago, Region M. De Santiago 8420383
ChileActive - Recruiting
Clínica Inmunocel ( Site 0201)
Santiago, Region M. De Santiago 7580206
ChileActive - Recruiting
FALP ( Site 0207)
Santiago, Region M. De Santiago 7500994
ChileSite Not Available
Bradfordhill-Clinical Area ( Site 0202)
Santiago 3871336, Region M. de Santiago 8420383
ChileSite Not Available
Clínica Inmunocel ( Site 0201)
Santiago 3871336, Region M. de Santiago 7580206
ChileSite Not Available
FALP ( Site 0207)
Santiago 3871336, Region M. de Santiago 7500921
ChileSite Not Available
Biocenter ( Site 0203)
Concepción 3893894, Región del Biobío 3898380 4070196
ChileSite Not Available
Universitaetsklinikum Essen ( Site 1302)
Essen, Nordrhein-Westfalen 45147
GermanySite Not Available
Universitaetsklinikum Essen ( Site 1302)
Essen 2928810, North Rhine-Westphalia 2861876 45147
GermanySite Not Available
Seoul National University Hospital-Oncology ( Site 1101)
Seoul, 03080
Korea, Republic ofSite Not Available
Health Pharma Professional Research S.A. de C.V: ( Site 0403)
Ciudad de México, Distrito Federal 03100
MexicoSite Not Available
Health Pharma Professional Research S.A. de C.V: ( Site 0403)
Mexico City 3530597, Mexico City 3527646 03100
MexicoSite Not Available
Centro de Investigacion Clinica de Oaxaca ( Site 0405)
Oaxaca, 68020
MexicoSite Not Available
Centro de Investigacion Clinica de Oaxaca ( Site 0405)
Oaxaca City 3522507, 68020
MexicoSite Not Available
Auckland City Hospital ( Site 1001)
Auckland, 1023
New ZealandSite Not Available
Auckland City Hospital ( Site 1001)
Auckland 2193733, 1023
New ZealandSite Not Available
Pratia MCM Krakow ( Site 0503)
Krakow 3094802, Lesser Poland Voivodeship 858786 30-727
PolandSite Not Available
Pratia MCM Krakow ( Site 0503)
Krakow, Malopolskie 30-727
PolandSite Not Available
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 0501)
Warsaw 756135, Masovian Voivodeship 858787 02-781
PolandSite Not Available
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site
Warszawa, Mazowieckie 02-781
PolandActive - Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 0501)
Warszawa, Mazowieckie 02-781
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0502)
Gdansk 3099434, Pomeranian Voivodeship 3337496 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0502)
Gdansk, Pomorskie 80-214
PolandSite Not Available
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0504)
Gliwice 3099230, Silesian Voivodeship 3337497 44-102
PolandSite Not Available
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0504)
Gliwice, Slaskie 44-102
PolandSite Not Available
Seoul National University Hospital-Oncology ( Site 1101)
Seoul 1835848, 03080
South KoreaSite Not Available
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 0703)
L'Hospitalet Del Llobregat, Barcelona 08908
SpainSite Not Available
Hospital Universitario de Salamanca ( Site 0702)
Salamanca, Castilla Y Leon 37007
SpainSite Not Available
Hospital Universitario de Salamanca ( Site 0702)
Salamanca 3111108, Castille and León 3336900 37007
SpainSite Not Available
Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 0701)
Madrid, 28041
SpainSite Not Available
Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 0701)
Madrid 3117735, 28041
SpainSite Not Available
Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)
Ankara, 06100
TurkeyActive - Recruiting
Hacettepe Universite Hastaneleri ( Site 0802)
Ankara, 06230
TurkeySite Not Available
Ondokuz Mayıs Universitesi ( Site 0803)
Samsun, 55270
TurkeySite Not Available
Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)
Ankara 323786, 06100
Turkey (Türkiye)Site Not Available
Hacettepe Universite Hastaneleri ( Site 0802)
Ankara 323786, 06230
Turkey (Türkiye)Site Not Available
Ondokuz Mayıs Universitesi ( Site 0803)
Samsun 740264, 55270
Turkey (Türkiye)Site Not Available
Glan Clwyd Hospital ( Site 0602)
Bodelwyddan, Denbighshire LL18 5UJ
United KingdomSite Not Available
Glan Clwyd Hospital ( Site 0602)
Bodelwyddan 2655283, Denbighshire LL18 5UJ
United KingdomSite Not Available
University College London Hospital ( Site 0605)
London, London, City Of NW1 2PG
United KingdomSite Not Available
University College London Hospital ( Site 0605)
London 2643743, London, City of NW1 2PG
United KingdomSite Not Available
Churchill Hospital ( Site 0604)
Oxford, Oxfordshire OX3 7LE
United KingdomSite Not Available
Churchill Hospital ( Site 0604)
Oxford 2640729, Oxfordshire OX3 7LE
United KingdomSite Not Available
The Christie NHS Foundation Trust ( Site 0603)
Manchester, m20 4bx
United KingdomSite Not Available
The Christie NHS Foundation Trust ( Site 0603)
Manchester 2643123, m20 4bx
United KingdomSite Not Available
University of Iowa-Holden Comprehensive Cancer Center ( Site 0115)
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
University of Iowa - Waukee ( Site 0111)
Waukee 4880981, Iowa 4862182 50263
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada ( Site 0114)
Las Vegas 5506956, Nevada 5509151 89169
United StatesSite Not Available
Clinical Research Alliance ( Site 0101)
Westbury, New York 11590
United StatesSite Not Available
Clinical Research Alliance ( Site 0101)
Westbury 5144040, New York 5128638 11590
United StatesSite Not Available

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