Table 1.
ClinicalTrials.gov identifier | Type | Title | Population | Outcome | Adverse events |
---|---|---|---|---|---|
NCT01953692 | Phase Ib | Programmed death-1 blockade with pembrolizumab in patients with classical Hodgkin’s lymphoma after brentuximab vedotin failure49 | 31 relapsed or refractory cHL patients previously treated with BV and relapsed after; ineligible for or refused autologous SCT | ORR 65% (90% CI 48–79%); CR 16% (90% CI 7–31%); PR 48%; PFS 69% at 24 weeks and 46% at 52 weeks | Hypothyroidism (16%), diarrhea (16%), nausea (13%) and pneumonitis (10%); Grade 3 AEs in four patients. Two patients discontinued treatment due to AEs |
NCT02453594 | Phase II | Study of pembrolizumab (MK-3475) in participants with relapsed or refractory classical Hodgkin’s lymphoma (MK-3475-087/KEYNOTE-087)53 | 210 patients with relapsed/refractory cHL who progressed or did not respond to either autologous SCT followed by BV (cohort 1), salvage chemotherapy followed by BV (cohort 2) or autologous SCT (cohort 3) | ORR 69.0% (95% CI 62.3–75.2%), CR 22.4% (95% CI 16.9–28.6%). ORRs were 73.9% for cohort 1, 64.2% for cohort 2, and 70.0% for cohort 3. 31 patients had a response ⩾6 months | Immune-mediated events in 28.6% of patients, most common AEs hypothyroidism (12.4%) and pyrexia (10.5%) |
Retrospective | Low-dose pembrolizumab for relapsed/refractory Hodgkin’s lymphoma: high efficacy with minimal toxicity54 | Five patients refractory to 1–6 therapy modalities. four of five patients had previously received BV | ORR 100%, CR 80% at median follow up of 18 months | Grade 1 diarrhea in 20%; grade 1 eczema (20%) |
AEs, adverse events; BV, brentuximab vedotin; cHL, classical Hodgkin’s lymphoma; CI, confidence interval; CR, complete remission; ORR, overall response rate; PFS, progression-free survival; PR, partial response; SCT, stem-cell transplant.