NCT Number: NCT02665650
Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Institut Catala d'Oncologia (ICO) L'Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
- 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.
- Relapsed or refractory disease after standard therapy including brentuximab vedotin (Adcetris®).
- 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.
- Completion of, if applicable, an autologous stem cell transplantation (ASCT) at least 3 months prior to first dose of study drug.
- Eastern Cooperative Oncology Group (ECOG) performance score (PS) <2.
Main Exclusion Criteria:
- 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.
- 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.
- 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.
- Prior allogeneic stem cell transplantation (SCT) within the last 5 years.
- Major surgery within 4 weeks prior to first dose of study drug.
Treatment and study plan
Pembrolizumab
BiologicalOther names: MK-3475, Keytruda
Primary outcomes
-
Number of participants experiencing dose limiting toxicity (DLT) during combination treatment
Time frame: Up to 9 months
Secondary outcomes
-
Number and frequency of adverse events
Time frame: Up to 30 months
-
Objective response rate (ORR)
Time frame: Up to 30 months
Sponsors and collaborators
Lead sponsor
Affimed GmbH
Industry
Collaborators
- Merck Sharp & Dohme LLC
- The Leukemia and Lymphoma Society
Registry information
Official study 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)
Important dates
- Study start
- 2016
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jan 28, 2016
- Registry last updated
- May 16, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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