Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
A Phase 1b Dose Escalation Study to Assess the Safety of AFM13 in Combination With Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (KEYNOTE- 206)
1 other identifier
interventional
30
2 countries
18
Brief Summary
The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2016
Typical duration for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2016
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 16, 2019
January 1, 2019
2.7 years
January 25, 2016
May 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants experiencing dose limiting toxicity (DLT) during combination treatment
Up to 9 months
Secondary Outcomes (2)
Number and frequency of adverse events
Up to 30 months
Objective response rate (ORR)
Up to 30 months
Study Arms (1)
AFM13 + Pembrolizumab
EXPERIMENTALParticipants receive AFM13 in escalating doses intravenously (IV) for up to 25 weeks, pembrolizumab as a fixed dose intravenously (IV) for up to 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of CD30+ classical Hodgkin lymphoma reconfirmed by histopathology. Note: where reconfirmation is not possible, patients will still be eligible where they have confirmation clearly documented in their medical records.
- Relapsed or refractory disease after standard therapy including brentuximab vedotin (Adcetris®).
- 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.
- Completion of, if applicable, an autologous stem cell transplantation (ASCT) at least 3 months prior to first dose of study drug.
- Eastern Cooperative Oncology Group (ECOG) performance score (PS) \<2.
You may not qualify if:
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- 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.
- 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.
- Prior allogeneic stem cell transplantation (SCT) within the last 5 years.
- Major surgery within 4 weeks prior to first dose of study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affimed GmbHlead
- Merck Sharp & Dohme LLCcollaborator
- The Leukemia and Lymphoma Societycollaborator
Study Sites (18)
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Yale Cancer Center
New Haven, Connecticut, 06510, United States
University of Miami Sylvester Comprehensive Cancer Center
Coral Gables, Florida, 33136, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Providence Portland Medical Center, Providence Cancer Center
Portland, Oregon, 97213, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9020, United States
Institut Catala d'Oncologia (ICO) L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Fundacion Privada Instituto de Investigacion Oncologica de Vall Hebron
Barcelona, 08035, Spain
Hospital Universitario 12 de Octubre, Servicio de Hematologia
Madrid, 28041, Spain
Salamanca University Hospital
Salamanca, 37007, Spain
Related Publications (1)
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.
PMID: 32730586DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2016
First Posted
January 28, 2016
Study Start
May 1, 2016
Primary Completion
January 1, 2019
Study Completion
March 1, 2019
Last Updated
May 16, 2019
Record last verified: 2019-01