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

Affimed

Status and phase: Completed; Phase 1

Conditions: Hodgkin Lymphoma

Treatments: Biological: Pembrolizumab; Biological: AFM13

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02665650

AFM13-103

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

AFM13 + Pembrolizumab

Experimental group

Description:

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.

Treatment:

Biological: Pembrolizumab

Biological: AFM13