Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
NCT ID: NCT02665650
Last Updated: 2019-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2016-05-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AFM13 + Pembrolizumab
Participants receive AFM13 in escalating doses intravenously (IV) for up to 25 weeks, pembrolizumab as a fixed dose intravenously (IV) for up to 52 weeks.
AFM13
Pembrolizumab
Interventions
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AFM13
Pembrolizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Relapsed or refractory disease after standard therapy including brentuximab vedotin (Adcetris®).
3. Completion of, if applicable, radiotherapy, chemotherapy, antibodies and immunoconjugates including brentuximab vedotin and/or another investigational drug which could interact with this trial not less than 4 weeks (or 5 half-lives of the drug, whichever occurs later) prior to first dose of study drug. Cessation of small molecule tyrosine kinase inhibitors must be at least 7 days prior to first dose of study drug.
4. Completion of, if applicable, an autologous stem cell transplantation (ASCT) at least 3 months prior to first dose of study drug.
5. Eastern Cooperative Oncology Group (ECOG) performance score (PS) \<2.
Exclusion Criteria
2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if the patient has previously participated in MK-3475 clinical trials.
3. Has received a live-virus vaccination within 30 days of planned treatment start. Note: Seasonal flu vaccines that do not contain live virus are permitted.
4. Prior allogeneic stem cell transplantation (SCT) within the last 5 years.
5. Major surgery within 4 weeks prior to first dose of study drug.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
The Leukemia and Lymphoma Society
OTHER
Affimed GmbH
INDUSTRY
Responsible Party
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Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Miami Sylvester Comprehensive Cancer Center
Coral Gables, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Medical Center
St Louis, Missouri, United States
Providence Portland Medical Center, Providence Cancer Center
Portland, Oregon, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Institut Catala d'Oncologia (ICO) L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Fundacion Privada Instituto de Investigacion Oncologica de Vall Hebron
Barcelona, , Spain
Hospital Universitario 12 de Octubre, Servicio de Hematologia
Madrid, , Spain
Salamanca University Hospital
Salamanca, , Spain
Countries
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References
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Bartlett NL, Herrera AF, Domingo-Domenech E, Mehta A, Forero-Torres A, Garcia-Sanz R, Armand P, Devata S, Izquierdo AR, Lossos IS, Reeder C, Sher T, Chen R, Schwarz SE, Alland L, Strassz A, Prier K, Choe-Juliak C, Ansell SM. A phase 1b study of AFM13 in combination with pembrolizumab in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2020 Nov 19;136(21):2401-2409. doi: 10.1182/blood.2019004701.
Other Identifiers
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AFM13-103
Identifier Type: -
Identifier Source: org_study_id
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