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OpenTrials
Completed

NCT Number: NCT02665650

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut Catala d'Oncologia (ICO) L'Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AFM13

Biological

Pembrolizumab

Biological

Other names: MK-3475, Keytruda

Primary outcomes

  1. Number of participants experiencing dose limiting toxicity (DLT) during combination treatment

    Time frame: Up to 9 months

Secondary outcomes

  1. Number and frequency of adverse events

    Time frame: Up to 30 months

  2. Objective response rate (ORR)

    Time frame: Up to 30 months

Sponsors and collaborators

Lead sponsor

Affimed GmbH

Industry

Collaborators

  • Merck Sharp & Dohme LLC
  • The Leukemia and Lymphoma Society

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2016
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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