A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL
Launched by GENMAB · Nov 9, 2020
Trial Information
Current as of April 29, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called epcoritamab, also known as EPKINLY™, for patients with diffuse large B-cell lymphoma (DLBCL) who have not responded to previous treatments or whose lymphoma has returned after treatment. The trial aims to see if epcoritamab is safe and effective compared to standard chemotherapy options. Participants will be randomly assigned to receive either epcoritamab, which is given as an injection under the skin, or a choice of standard chemotherapy drugs, which are delivered through an IV. To be eligible for this trial, patients must have had at least one prior cancer treatment and show signs of their disease on scans.
Participants in the trial can expect a structured treatment schedule that includes regular visits for injections or chemotherapy sessions. The trial will last up to five years, and patients will continue to be monitored even after their treatment ends. Key eligibility criteria include having a specific type of lymphoma, not being eligible for certain transplant options, and having a life expectancy of more than two months with standard care. Importantly, patients with certain other health issues or who have had specific recent treatments may not be able to join the trial.
Gender
ALL
Eligibility criteria
- Main Inclusion Criteria:
- • 1. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis
- 2. One of the confirmed histologies below with CD20-positivity:
- • 1. DLBCL, NOS, including de novo or histologically transformed from FL
- • 2. "Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
- • 3. FL Grade 3B
- • 4. T-cell/histiocyte-rich large B-cell lymphoma
- • 3. ECOG PS score of 0-2
- • 4. Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
- • 5. Patients must have detectable disease by PET scan and measurable by CT scan or MRI
- • 6. Acceptable renal and liver function
- • 7. Life expectancy \>2 months on SOC treatment
- Main Exclusion Criteria:
- • 1. Primary Central Nervous System (CNS) tumor or known CNS involvement
- • 2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
- • 3. Major surgery within 4 weeks prior to randomization
- • 4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
- • 5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
- • 6. ASCT within 100 days of randomization
- • 7. Treatment with CAR-T therapy within 100 days prior to randomization
- • 8. Seizure disorder requiring anti-epileptic therapy
- • 9. Clinically significant cardiac disease
About Genmab
Genmab is a leading biotechnology company focused on the development and commercialization of innovative antibody therapeutics for the treatment of cancer and other serious diseases. Founded in 1999 and headquartered in Copenhagen, Denmark, Genmab leverages its proprietary antibody technology platforms to create differentiated therapies that address unmet medical needs. The company's robust pipeline includes several promising candidates in various stages of clinical development, reflecting its commitment to advancing the field of immunotherapy and improving patient outcomes. Through strategic collaborations and a strong focus on scientific excellence, Genmab aims to transform the landscape of cancer treatment and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Salt Lake City, Utah, United States
Waukesha, Wisconsin, United States
Fort Sam Houston, Texas, United States
Yakima, Washington, United States
Knoxville, Tennessee, United States
Kaohsiung, , Taiwan
Taipei, , Taiwan
Irvine, California, United States
Taipei, , Taiwan
Budapest, , Hungary
Concord, , Australia
Westmead, , Australia
Tel Aviv, , Israel
Barcelona, , Spain
Singapore, , Singapore
Taipei, , Taiwan
Nice, , France
Seoul, , Korea, Republic Of
London, , United Kingdom
Salamanca, , Spain
Pierre Bénite, , France
Rouen, , France
Lyon, , France
Utrecht, , Netherlands
Milan, , Italy
Brussels, , Belgium
Seoul, , Korea, Republic Of
Tampere, , Finland
Jerusalem, , Israel
Rotterdam, , Netherlands
Indianapolis, Indiana, United States
Haifa, , Israel
Seoul, , Korea, Republic Of
Ulsan, , Korea, Republic Of
Jerusalem, , Israel
Ankara, , Turkey
Lexington, Kentucky, United States
Tokyo, , Japan
New Orleans, Louisiana, United States
Lleida, , Spain
Stockholm, , Sweden
Busan, , Korea, Republic Of
Sevilla, , Spain
Santander, , Spain
Bedford Park, , Australia
Cáceres, , Spain
Freiburg, , Germany
Gent, , Belgium
Tainan, , Taiwan
Netanya, , Israel
Beijing, , China
Ravenna, , Italy
Würzburg, , Germany
Mie, , Japan
Tokyo, , Japan
Istanbul, , Turkey
Plymouth, , United Kingdom
Winston Salem, North Carolina, United States
Fukushima, , Japan
Limoges, , France
Kortrijk, , Belgium
Pavia, , Italy
Madrid, , Spain
Okayama, , Japan
Norwich, , United Kingdom
Truro, , United Kingdom
Tokyo, , Japan
Toyoake, , Japan
Seoul, , Korea, Republic Of
Beijing, , China
Sevilla, , Spain
Dordrecht, , Netherlands
Roosendaal, , Netherlands
Vejle, , Denmark
Berlin, , Germany
Paris, , France
Seoul, , Korea, Republic Of
Bayonne, , France
Essen, , Germany
Jette, , Belgium
Madrid, , Spain
Nottingham, , United Kingdom
Seoul, , Korea, Republic Of
Nantes, , France
Córdoba, , Spain
Busan, , Korea, Republic Of
Nanchang, , China
Malmö, , Sweden
Madrid, , Spain
Yantai, , China
Fukuoka, , Japan
Suita, , Japan
Pontoise, , France
Chengdu, , China
Southampton, , United Kingdom
Daegu, , Korea, Republic Of
Manchester, , United Kingdom
Nagoya, , Japan
Sendai, , Japan
Goes, , Netherlands
Haifa, , Israel
Madrid, , Spain
Memphis, Tennessee, United States
Ogden, Utah, United States
Haarlem, , Netherlands
Tours, , France
Brugge, , Belgium
Shenyang, , China
Aalborg, , Denmark
Suzhou, , China
Beersheba, , Israel
Barcelona, , Spain
Wuhan, , China
Szekesfehervar, , Hungary
La Louvière, , Belgium
Tianjin, , China
Kashiwa, , Japan
Waratah, , Australia
Sevilla, , Spain
Moscow, , Russian Federation
Antwerp, , Belgium
Zhengzhou, , China
Woluwe Saint Lambert, , Belgium
Hokkaido, , Japan
Trondheim, , Norway
Tel Hashomer, , Israel
Camden, New Jersey, United States
Ankara, , Turkey
Changchun, , China
Greenville, North Carolina, United States
San Giovanni Rotondo, , Italy
Quimper, , France
Madrid, , Spain
Linz, , Austria
Beijing, , China
Nagoya, , Japan
Arnhem, , Netherlands
Hunan, , China
Dalian, , China
London, , United Kingdom
Ankara, , Turkey
Yamagata, , Japan
Brescia, , Italy
Kraków, , Poland
Meldola, , Italy
Chicago, Illinois, United States
Gothenburg, , Sweden
İzmir, , Turkey
Baoding, , China
Toruń, , Poland
Matsuyama, , Japan
Saitama, , Japan
ōsaka Sayama, , Japan
Linz, , Austria
Hangzhou, , China
łódź, , Poland
Wrocław, , Poland
Montréal, , Canada
Kaposvár, , Hungary
İzmir, , Turkey
La Rochelle, , France
Trabzon, , Turkey
Richmond, Virginia, United States
Hubei, , China
Indianapolis, Indiana, United States
Katowice, , Poland
Jackson, Michigan, United States
Saint Louis Park, Minnesota, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Darlinghurst, , Australia
Frankston, , Australia
South Brisbane, , Australia
Graz, , Austria
Salzburg, , Austria
Leuven, , Belgium
Menen, , Belgium
Sint Niklaas, , Belgium
Turnhout, , Belgium
Kitchener, , Canada
Québec City, , Canada
Saint John's, , Canada
Aarhus, , Denmark
Herlev, , Denmark
Helsinki, , Finland
Kuopio, , Finland
Oulu, , Finland
Turku, , Finland
Amiens, , France
Brest, , France
Caen, , France
Dijon, , France
Marseille, , France
Paris, , France
Pessac, , France
Poitiers, , France
Cologne, , Germany
Kiel, , Germany
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Győr, , Hungary
Nyiregyhaza, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Tatabánya, , Hungary
Bari, , Italy
Bergamo, , Italy
Bologna, , Italy
Milano, , Italy
Milan, , Italy
Novara, , Italy
Turin, , Italy
Venezia, , Italy
Fukuyama, , Japan
Kyoto, , Japan
Nagoya, , Japan
Tokyo, , Japan
Busan, , Korea, Republic Of
Geumam, , Korea, Republic Of
Seoul, , Korea, Republic Of
'S Hertogenbosch, , Netherlands
Breda, , Netherlands
Hague, , Netherlands
Rotterdam, , Netherlands
Oslo, , Norway
Gdańsk, , Poland
Olsztyn, , Poland
Opole, , Poland
Skorzewo, , Poland
Słupsk, , Poland
Warsaw, , Poland
Warszawa, , Poland
łódź, , Poland
Kazan, , Russian Federation
Leningrad, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Nizhny Novgorod, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Tula, , Russian Federation
Kent Ridge, , Singapore
Singapore, , Singapore
Badalona, , Spain
Cadiz, , Spain
Cáceres,, , Spain
Borås, , Sweden
Ankara, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Tekirdağ, , Turkey
Birmingham, , United Kingdom
Sutton, , United Kingdom
Wolverhampton, , United Kingdom
Guangxi, , China
Qingdao, , China
Trieste, , Italy
Guangdong, , China
Shenzhen, , China
Rome, , Italy
Zhenjiang, , China
Dallas, Texas, United States
Shanxi, , China
Wuhan, , China
Roskilde, , Denmark
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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