Table 2.
Ongoing trials evaluating response of Hodgkin’s lymphoma to pembrolizumab at various stages of disease.
| ClinicalTrials.gov identifier | Phase | Title | HL patient population | Recruiting? |
|---|---|---|---|---|
| Previously untreated cHL | ||||
| NCT03226249 | II | Phase II study of PET-directed frontline therapy with pembrolizumab and AVD for patients with classical Hodgkin lymphoma | Previously untreated classical Hodgkin’s lymphoma | Yes |
| Primary refractory early-stage cHL | ||||
| NCT03179917 | II | Pembrolizumab and involved site radiation therapy for early stage relapsed or primary refractory Hodgkin lymphoma | Patients with relapsed or refractory stage I–II classical Hodgkin’s lymphoma. Possible prior treatments include chemotherapy alone or combined with radiation. In cases of prior combined therapy, area of relapse is outside the previous radiation field | Yes |
| Combination with biologic agents | ||||
| NCT02665650 | Ib | A phase Ib dose escalation study to assess the safety of AFM13 in combination with pembrolizumab in patients with relapsed or refractory classical Hodgkin lymphoma (KEYNOTE-206) | CD30+ classical Hodgkin’s lymphoma, relapsed or refractory after standard therapy including BV, SCT, or both | Yes |
| NCT02875067 | I/II | Safety and efficacy study of combination of pembrolizumab and lenalidomide, in patients with relapsed non-Hodgkin and Hodgkin lymphoma | History of at least two prior therapies, not eligible for SCT | Yes |
| NCT02362035 | I/II | A phase Ib/II proof-of-concept study of the combination of ACP-196 (acalabrutinib) and pembrolizumab in subjects with hematologic malignancies | Diagnosis of a hematologic malignancy without central nervous system involvement | No |
| NCT03150329 | I | A phase I study of pembrolizumab plus vorinostat for relapsed or refractory diffuse large B-cell lymphoma, follicular lymphoma, and Hodgkin lymphoma | Relapsed or refractory classical Hodgkin’s lymphoma (all histological subtypes except nodular lymphocyte predominant), stable, partial response or disease progression after at least one prior regimen, ineligible or declining SCT | Yes |
| NCT03179930 | II | Combination therapy with entinostat and pembrolizumab in relapsed and refractory lymphomas | Hodgkin’s lymphoma patients that have received at least two prior regimens | Yes |
| NCT03236935 | Ib | Phase Ib trial of L-NMMA in combination with pembrolizumab in patients with melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, or microsatellite instability-high/mismatch repair deficient cancer | Classical Hodgkin’s lymphoma that has relapsed after three or more lines of therapy or is refractory to treatment | Not yet |
| NCT03010176 | I | Study of MK-1454 alone or in combination with pembrolizumab in participants with advanced/metastatic solid tumors or lymphomas (MK-1454-001) | Histologically or cytologically confirmed advanced/metastatic solid tumor or lymphoma of any type that is refractory to all treatment known to confer clinical benefit and can be tolerated by the patient | Yes |
| Combination with salvage chemotherapy | ||||
| NCT03077828 | II | Phase II trial of pembrolizumab in combination with ICE salvage chemotherapy for relapsed/refractory Hodgkin lymphoma | Relapsed/refractory Hodgkin’s lymphoma, with at least one but no more than two lines of prior chemotherapy | Not yet |
| Other | ||||
| NCT02684292 | III | A phase III, randomized, open-label, clinical trial to compare pembrolizumab with brentuximab vedotin in subjects with relapsed or refractory classical Hodgkin lymphoma | Relapsed/refractory classical Hodgkin’s lymphoma in BV-naïve patients that progressed or did not respond to auto-SCT, or salvage chemotherapy. Patients who are not candidates for auto-SCT received at least two chemotherapy regimens and are BV-naïve are eligible | Yes |
| NCT02362997 | II | A phase II study of pembrolizumab (MK-3475) after autologous stem-cell transplantation in patients with relapsed/refractory classical Hodgkin lymphoma and, diffuse large B cell lymphoma and T-cell non-Hodgkin lymphoma | Classical Hodgkin’s lymphoma that failed to achieve CR after initial chemotherapy regimen or relapsed and was treated with auto-SCT for chemo-sensitive diseases | Yes |
BV, brentuximab vedotin; CR, complete remission; SCT, stem-cell transplant.