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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.
 
ClinicalTrials.gov Identifier: NCT02665650
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme LLC
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Affimed GmbH

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
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


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02665650


Locations
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Sponsors and Collaborators
Affimed GmbH
Merck Sharp & Dohme LLC
The Leukemia and Lymphoma Society
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Affimed GmbH
ClinicalTrials.gov Identifier: NCT02665650    
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:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action