Back to resultsStudy of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Primary Purpose
Hodgkin Lymphoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AFM13
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma
Eligibility Criteria
Main Inclusion Criteria:
- 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.
Main Exclusion Criteria:
- 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.
Sites / Locations
- University of Alabama Comprehensive Cancer Center
- Mayo Clinic
- City of Hope National Medical Center
- Ronald Reagan UCLA Medical Center
- Yale Cancer Center
- University of Miami Sylvester Comprehensive Cancer Center
- Mayo Clinic
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- University of Michigan Comprehensive Cancer Center
- Mayo Clinic
- Washington University Medical Center
- Providence Portland Medical Center, Providence Cancer Center
- University of Texas Southwestern Medical Center
- Institut Catala d'Oncologia (ICO) L'Hospitalet
- Fundacion Privada Instituto de Investigacion Oncologica de Vall Hebron
- Hospital Universitario 12 de Octubre, Servicio de Hematologia
- Salamanca University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AFM13 + Pembrolizumab
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of participants experiencing dose limiting toxicity (DLT) during combination treatment
Secondary Outcome Measures
Number and frequency of adverse events
Objective response rate (ORR)
Full Information
NCT ID
NCT02665650
First Posted
January 25, 2016
Last Updated
May 15, 2019
Sponsor
Affimed GmbH
Collaborators
Merck Sharp & Dohme LLC, The Leukemia and Lymphoma Society
1. Study Identification
Unique Protocol Identification Number
NCT02665650
Brief Title
Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affimed GmbH
Collaborators
Merck Sharp & Dohme LLC, The Leukemia and Lymphoma Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AFM13 + Pembrolizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
AFM13
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, Keytruda
Primary Outcome Measure Information:
Title
Number of participants experiencing dose limiting toxicity (DLT) during combination treatment
Time Frame
Up to 9 months
Secondary Outcome Measure Information:
Title
Number and frequency of adverse events
Time Frame
Up to 30 months
Title
Objective response rate (ORR)
Time Frame
Up to 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
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.
Main Exclusion Criteria:
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.
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Providence Portland Medical Center, Providence Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9020
Country
United States
Facility Name
Institut Catala d'Oncologia (ICO) L'Hospitalet
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Fundacion Privada Instituto de Investigacion Oncologica de Vall Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre, Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Salamanca University Hospital
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32730586
Citation
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.
Results Reference
derived
Learn more about this trial
Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
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