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

Phase 1

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Biological: AFM13; Biological: Pembrolizumab

• Registration Number: NCT02665650
• Lead Sponsor: Affimed GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-28
• Study Start: 2016-05
• Status Verified: 2019-01
• Primary Completion: 2019-01
• Study Completion: 2019-03
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AFM13 + Pembrolizumab	AFM13	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.
AFM13 + Pembrolizumab	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.

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing dose limiting toxicity (DLT) during combination treatment	Up to 9 months

Secondary Outcome Measures

Name	Time	Method
Number and frequency of adverse events	Up to 30 months
Objective response rate (ORR)	Up to 30 months

Trial Locations

Locations (16)

University of Miami Sylvester Comprehensive Cancer Center; 🇺🇸 Coral Gables, Florida, United States

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Fundacion Privada Instituto de Investigacion Oncologica de Vall Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 de Octubre, Servicio de Hematologia; 🇪🇸 Madrid, Spain

Salamanca University Hospital; 🇪🇸 Salamanca, Spain

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Providence Portland Medical Center, Providence Cancer Center; 🇺🇸 Portland, Oregon, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

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

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States