Clinical Trials /

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

NCT02665650

Description:

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.

Related Conditions:
  • Hodgkin Lymphoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: AFM13-103
  • NCT ID: NCT02665650

Conditions

  • Hodgkin Lymphoma

Interventions

DrugSynonymsArms
AFM13AFM13 + Pembrolizumab
PembrolizumabMK-3475, KeytrudaAFM13 + Pembrolizumab

Purpose

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 Arms

NameTypeDescriptionInterventions
AFM13 + PembrolizumabExperimentalParticipants receive AFM13 in escalating doses intravenously (IV) for up to 25 weeks, pembrolizumab as a fixed dose intravenously (IV) for up to 52 weeks.

    Eligibility 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 status (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).
    
              5. Major surgery within 4 weeks prior to first dose of study drug.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Number of participants experiencing dose limiting toxicity (DLT) during combination treatment
    Time Frame:Up to 9 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Number and frequency of adverse events
    Time Frame:Up to 30 months
    Safety Issue:
    Description:
    Measure:Objective response rate (ORR)
    Time Frame:Up to 30 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Affimed GmbH

    Last Updated

    August 24, 2017