Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02321592 | GHSG-AFM13 An Open-label, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma | PHASE2 | COMPLETED | 23 | — | — | May 1, 2015 | Jul 1, 2020 | Nov 13, 2020 | 1 | Germany |
| NCT02665650 | Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma | PHASE1 | COMPLETED | 30 | — | — | May 1, 2016 | Mar 1, 2019 | May 16, 2019 | 18 | United States, Spain |
| NCT01221571 | A Study to Assess AFM13 in Patients With Hodgkin Lymphoma | PHASE1 | COMPLETED | 28 | — | — | Oct 1, 2010 | Jun 1, 2013 | Jun 26, 2013 | 3 | United States, Germany |
Measure occurrence of adverse events and monitor laboratory safety parameters. Immunogenicity of AFM13.
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | AFM13 is administered three times a week (e.g. monday-wednesday-friday) for 8 consecutive weeks. Arm A ist closed. |
| Arm B | ACTIVE_COMPARATOR | AFM13 is administered three times a week (e.g. monday-wednesday-friday) for 2 consecutive weeks followed by a weekly appication 6 consecutive weeks. Arm B is closed. |
| Arm C | ACTIVE_COMPARATOR | AFM13 is administered for five consecutive days a week as continuous infusion for 8 consecutive weeks |
| 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. |
| AFM13 | EXPERIMENTAL | IV (intravenous) infusion, dose escalation |
| Name | Type | Description |
|---|---|---|
| AFM13 | DRUG | - |
| Pembrolizumab | BIOLOGICAL | - |
| AFM 13 | DRUG | Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations. |
Inclusion Criteria: * Patients with diagnosis of classical HL reconfirmed by histopathology and relapsed or refractory disease after standard therapy including brentuximab vedotin and anti-PD1 or PD-L1 antibodies * Age: 18 years or older (both genders) * ECOG performance status ≤2 * Life expectancy...