Description:
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.
Title
- Brief Title: Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
- 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 IDs
- ORG STUDY ID:
AFM13-103
- NCT ID:
NCT02665650
Conditions
Interventions
Drug | Synonyms | Arms |
---|
AFM13 | | AFM13 + Pembrolizumab |
Pembrolizumab | MK-3475, Keytruda | AFM13 + Pembrolizumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
AFM13 + Pembrolizumab | Experimental | 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. | |
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants experiencing dose limiting toxicity (DLT) during combination treatment |
Time Frame: | Up to 9 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number and frequency of adverse events |
Time Frame: | Up to 30 months |
Safety Issue: | |
Description: | |
Measure: | Objective response rate (ORR) |
Time Frame: | Up to 30 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Affimed GmbH |
Last Updated
May 16, 2019