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

Hodgkin Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665650
• Other study ID #: AFM13-103
• Status: Completed
• Phase: Phase 1
• Start date: May 2016
• Est. completion date: March 2019

Study information

• Verified date: January 2019
• Source: Affimed GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Biological:
• AFM13

• Pembrolizumab

Locations

Country	Name	City	State
Spain	Fundacion Privada Instituto de Investigacion Oncologica de Vall Hebron	Barcelona
Spain	Institut Catala d'Oncologia (ICO) L'Hospitalet	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre, Servicio de Hematologia	Madrid
Spain	Salamanca University Hospital	Salamanca
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Miami Sylvester Comprehensive Cancer Center	Coral Gables	Florida
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	Mayo Clinic	Jacksonville	Florida
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Yale Cancer Center	New Haven	Connecticut
United States	Providence Portland Medical Center, Providence Cancer Center	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Affimed GmbH	Merck Sharp & Dohme Corp., The Leukemia and Lymphoma Society

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing dose limiting toxicity (DLT) during combination treatment		Up to 9 months
Secondary	Number and frequency of adverse events		Up to 30 months
Secondary	Objective response rate (ORR)		Up to 30 months