Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT02665650|
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : May 16, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Biological: AFM13 Biological: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||March 2019|
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.
- Number of participants experiencing dose limiting toxicity (DLT) during combination treatment [ Time Frame: Up to 9 months ]
- Number and frequency of adverse events [ Time Frame: Up to 30 months ]
- Objective response rate (ORR) [ Time Frame: Up to 30 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665650
|Responsible Party:||Affimed GmbH|
|Other Study ID Numbers:||
|First Posted:||January 28, 2016 Key Record Dates|
|Last Update Posted:||May 16, 2019|
|Last Verified:||January 2019|
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Immunological