Working… Menu
Trial record 1 of 1 for:    AFM13-103
Previous Study | Return to List | Next Study

Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02665650
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : May 16, 2019
Merck Sharp & Dohme Corp.
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Affimed GmbH

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.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Biological: AFM13 Biological: Pembrolizumab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Biological: AFM13
Biological: Pembrolizumab
Other Names:
  • MK-3475
  • Keytruda

Primary Outcome Measures :
  1. Number of participants experiencing dose limiting toxicity (DLT) during combination treatment [ Time Frame: Up to 9 months ]

Secondary Outcome Measures :
  1. Number and frequency of adverse events [ Time Frame: Up to 30 months ]
  2. Objective response rate (ORR) [ Time Frame: Up to 30 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  1. 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.
  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.

Main Exclusion Criteria:

  1. 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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02665650

Layout table for location information
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06510
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Coral Gables, Florida, United States, 33136
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
United States, Oregon
Providence Portland Medical Center, Providence Cancer Center
Portland, Oregon, United States, 97213
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9020
Institut Catala d'Oncologia (ICO) L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Fundacion Privada Instituto de Investigacion Oncologica de Vall Hebron
Barcelona, Spain, 08035
Hospital Universitario 12 de Octubre, Servicio de Hematologia
Madrid, Spain, 28041
Salamanca University Hospital
Salamanca, Spain, 37007
Sponsors and Collaborators
Affimed GmbH
Merck Sharp & Dohme Corp.
The Leukemia and Lymphoma Society

Layout table for additonal information
Responsible Party: Affimed GmbH Identifier: NCT02665650     History of Changes
Other Study ID Numbers: AFM13-103
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents