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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Affimed GmbH
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Affimed GmbH
ClinicalTrials.gov Identifier:
NCT02665650
First received: January 25, 2016
Last updated: June 12, 2017
Last verified: June 2017
  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.

Condition Intervention Phase
Hodgkin Lymphoma Biological: AFM13 Biological: Pembrolizumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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)

Resource links provided by NLM:


Further study details as provided by Affimed GmbH:

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

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

Estimated Enrollment: 33
Study Start Date: May 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02665650

Contacts
Contact: Gudrun Beck +49 6221 65307 ext 23 g.beck@affimed.com

Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center Recruiting
Coral Gables, Florida, United States, 33136
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Stephen M Ansell, M.D. Ph.D.         
United States, Missouri
Washington University Medical Center Recruiting
Saint Louis, Missouri, United States, 63110
United States, Oregon
Providence Portland Medical Center, Providence Cancer Center Recruiting
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Affimed GmbH
Merck Sharp & Dohme Corp.
The Leukemia and Lymphoma Society
  More Information

Responsible Party: Affimed GmbH
ClinicalTrials.gov Identifier: NCT02665650     History of Changes
Other Study ID Numbers: AFM13-103
Study First Received: January 25, 2016
Last Updated: June 12, 2017

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017