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

May 15, 2019 updated by: Affimed GmbH

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre, Servicio de Hematologia
      • Salamanca, Spain, 37007
        • Salamanca University Hospital
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Institut Català d'Oncología (ICO) L'Hospitalet
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama Comprehensive Cancer Center
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Cancer Center
    • Florida
      • Coral Gables, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center, Providence Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390-9020
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Keytruda
  • MK-3475

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affimed GmbH

Collaborators

Merck Sharp & Dohme LLC
The Leukemia and Lymphoma Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFM13-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe